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Find your job with Sintetica SA

R&d laboratory analyst

Sintetica SA
Switzerland, Ticino, Mendrisio - Sintetica SA
Pharmaceutical
Research and Development

Established in 1921 in Switzerland, Sintetica is now in its first century of activity and growth. Leader in its field in Switzerland, Sintetica is a pharmaceutical company delivering injectable anesthetics and analgesics to patients worldwide through innovative solutions with excellence in development, production and marketing. People are our most valuable asset and our values put the patient and the quality of our products at the heart of our business. That is why we believe in the Great Place to Work culture that promotes creativity and informed risk-taking in an exciting and comfortable work environment.   To strengthen our Pharmaceutical Development team at our headquarter in Mendrisio (Switzerland), we are currently looking for a R&D Laboratory Analyst (fulltime position).   Position summary The main activities will be the execution of chemical analyses on finished products within the Stability Group of the Pharmaceutical Development Laboratory. Other activities will be the execution of experiments and analysis related to pharmaceutical development projects as well as participation in the validation and transfer of analytical method. He/She will operate under the direct coordination of the Pharmaceutical Development Laboratory Manager and in collaboration with the other people working in the R&D Laboratory team and in the Pharmaceutical Development Department which the R&D Laboratory is part of.   Essential tasks and responsibilities - Analytical control of finished products. - Instrumental analysis executions (HPLC, UV-Vis, IR, pH, Karl Fisher, particle size, titrator, LOD, GC). - Data analysis and interpretation. - Stability studies and related changes or requests from regulatory authorities. - Editing of SOPs, Batch Records and CoA. - Support to the Project Leader in the implementation of the new LIMS in the laboratory.   Position skills and requirements - Bachelor's degree in a scientific discipline (Chemistry and Pharmaceutical Science). - 5-10 years' experience as R&D Laboratory Analyst. - Knowledge of principal analytical instruments as HPLC, GC, UV, FT-IR. - Good Knowledge of GMP guidelines. - Good English communication and writing skills. - Experience in implementing a LIMS laboratory will be considered an asset - The knowledge of French would be an asset. - Able to work independently and to complete assigned tasks within established deadlines. - Able to work in a team. - Strong attention to details. - Commitment to continuous improvement.   We offer Fulltime permanent employment in a young, dynamic working environment and positive culture. Sintetica promotes Diversity and Gender Equality.  

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15/09/2021

Production manager

Sintetica SA
Switzerland, Ticino, Mendrisio - Sintetica SA
Pharmaceutical
Production

Established in 1921 in Switzerland, Sintetica is now in its first century of activity and growth. Leader in its field in Switzerland, Sintetica is a pharmaceutical company delivering injectable anesthetics and analgesics to patients worldwide through innovative solutions with excellence in development, production and marketing. People are our most valuable asset and our values put the patient and the quality of our products at the heart of our business. That is why we believe in the Great Place to Work culture that promotes creativity and informed risk-taking in an exciting and comfortable work environment. For our production site in our headquarter in Mendrisio (Switzerland), we are currently looking for a fulltime highly motivated and experienced Production Manager.     Position summary   The Production Manager coordinates and controls the activities of the production departments in Mendrisio in order to deliver the products on time and within budget.   Essential tasks and responsibilities   The Production Manager will: - Be responsible for managing and allocation of the staff of the production lines following the Company guidelines. - Define the tasks of the production departments and verify that the employees are trained, the SOPs are distributed, that the work environment is safe, secure, cleaned and disinfected. - Approve the weekly production programs together with Supply Chain, ensuring optimal management of the resources at disposal. - Be responsible for the maintenance of the production departments and coordinate activities to ensure production continuity and efficiency. - Be responsible for defining flows within the production departments, manufacturing and packaging processes, unit product formulas, as well as for drafting and approving Master Batch Records and SOPs, in conjunction with the departments involved. - Ensure that production departments collaborate on innovation and digitalization projects, guaranteeing plant availability, critically checking the impact on business continuity and alignment with company objectives. - Participate in the definition of production processes, in the drafting and approval of Master Batch Records and in the preparation of validation protocols together with the Qualified Person (QP) and the managers of the Quality Assurance and Regulatory Affairs Departments. - Participate in the management of deviations and the implementation of appropriate corrective and preventive actions for the department, collaborating with the competent departments. - Consolidate the information on the efficiency status of the production infrastructure and reports any shortcomings to the Technical Direction, needs to the Engineering Department and collaborate in defining the investment budget for the production areas. - Cooperate with the R&D Manager on the definition and scale-up of processes.   Required skills and core competences   - Degree in engineering, scientific subjects or similar - At least 5 years' experience in a similar position in the pharmaceutical manufacturing field. Experience in injectable will be considered an asset - Planning and organization skills - Excellent experience in personnel management. - Leadership, open-mindset and innovative approach. - Digital and innovation orientation. - Excellent knowledge of spoken and written English, French will be considered an asset.   We offer  Fulltime permanent employment in a young, challenging working environment and positive culture. Sintetica promotes Diversity and Gender Equality.              

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03/09/2021

Welcome desk & event - intern

Sintetica SA
Switzerland, Ticino, Mendrisio - Sintetica SA
Pharmaceutical
Telephonist / Secretariat / General services

Established in 1921 in Switzerland, Sintetica is now in its first century of activity and growth. Leader in its field in Switzerland, Sintetica is a pharmaceutical company delivering injectable anesthetics and analgesics to patients worldwide through innovative solutions with excellence in development, production and marketing. People are our most valuable asset and our values put the patient and the quality of our products at the heart of our business. That is why we believe in the Great Place to Work culture that promotes creativity and informed risk-taking in an exciting and comfortable work environment.   To strengthen our Welcome Desk & Event Planner team at our headquarter in Mendrisio (Switzerland), we are currently looking for a highly motivated Welcome Desk & Event Intern (internship position).   Position Description The "Welcome Desk & Event" trainee will be supporting the Welcome Desk & Event Planning Team.   Essential tasks and responsibilities: ? Welcome guests, management of calls, e-mails, and common areas? Coordinate and support the organization of events and meetings? Assist the Event Manager in the daily activities and during events? Manage contacts with F&B and Catering suppliers? Organization of various meetings and gatherings (preparation of necessary material anddocumentation)? Preparation of documents, drafting of texts and PowerPoint presentations for the department? Drafting of letters and communications and management of the flow of information to otherbusiness units or externally? Organization of travel and hotel reservations for employees? Manage the appointment diary Position skills and requirements: ? Fluency in English, Italian, French, knowledge of German will be considered an asset? Willingness to travel? Commercial or communication background? Flexibility, proactiveness and commitment to continuous improvement.? Ability to work in a team.? Excellent organization and time management skills.? Preferably previous experience in welcome desk & event field gained in internships or similar   We offer Fulltime internship in a young, dynamic working environment and positive culture. Sintetica promotes Diversity and Gender Equality.  

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30/08/2021

Clinical development specialist

Sintetica SA
Switzerland, Ticino, Mendrisio - Sintetica SA
Pharmaceutical
Research and Development

Established in 1921 in Switzerland, Sintetica is now in its first century of activity and growth. Leader in its field in Switzerland, Sintetica is a pharmaceutical company delivering injectable anesthetics and analgesics to patients worldwide through innovative solutions with excellence in development, production and marketing. People are our most valuable asset and our values put the patient and the quality of our products at the heart of our business. That is why we believe in the Great Place to Work culture that promotes creativity and informed risk-taking in an exciting and comfortable work environment. To strengthen our Clinical Development Department at our headquarter in Mendrisio (Switzerland), we are currently looking for a Clinical Development Specialist (fulltime position).   Position summary   The Clinical Development Specialist will manage and support the clinical development of the global company portfolio (a mix of established products and innovative therapies), following all the steps of clinical projects, from clinical trial design to the submission of the registration dossier. She/He will operate under the direct coordination of the Clinical Development Corporate Manager and in collaboration with the Clinical Development Team and the Scientific Affairs Department. She/He will be the projects' scientific reference point for all the relevant internal and external stakeholders.   Essential tasks and responsibilities   - Responsible for clinical research and development projects. - Coordination and support of strategic activities related to the assigned project. - Provides scientific expertise to functional areas such as marketing, non-clinical development, pharmacovigilance and regulatory affairs in accordance with the company's strategy. - Overview of clinical study protocols and other critical documents. - Support to clinical operations and scientific supervision during clinical trials. - Preparation of scientific advices with EU and US authorities. - Medical writing: contribution to the preparation of pre-clinical and clinical (CTD modules 2, 4 and 5) sections for FDA and EMA dossiers, preparation of EU Pediatric Investigation Plans (PIP), US Pediatric Study Plan (PSP), Investigator Brochures, Briefing Documents, answers to objections, etc. - Support during European Authorities and FDA GCP inspections.   Required skills and core competences   - Master's Degree in health-related subjects (e.g., pharmacy, biotechnology, biology, or similar disciplines). - Previous 3-5 years' experience in the pharmaceutical industry. - Fluent in written and spoken English. - Excellent communication skills, proactivity, autonomy, precision, teamwork aptitude. - Management and organizational skills, flexibility, learning agility and strategic thinking. - Commitment to continuous improvement. - Adaptability to a multicultural environment.   We offer Fulltime permanent employment in a young working environment and positive culture. Sintetica promotes diversity and gender equality.

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27/08/2021

Cmc specialist

Sintetica SA
Switzerland, Ticino, Mendrisio - Sintetica SA
Pharmaceutical
Research and Development

Established in 1921 in Switzerland, Sintetica is now in its first century of activity and growth. Leader in its field in Switzerland, Sintetica is a pharmaceutical company delivering injectable anesthetics and analgesics to patients worldwide through innovative solutions with excellence in development, production and marketing.People are our most valuable asset and our values put the patient and the quality of our products at the heart of our business. That is why we believe in the Great Place to Work culture that promotes creativity and informed risk-taking in an exciting and comfortable work environment.To strengthen our Pharmaceutical Development Department at our headquarter in Mendrisio (Switzerland), we are currently looking for a CMC Specialist (fulltime position). Position summary The CMC Specialist will manage projects related to both:? Preparation of new finished products dossier.? Quality change dossiers to be approved. He/She will operate under the direct coordination of the CMC Strategy Manager and in collaboration with the Pharmaceutical Development Team and the colleagues in the Scientific Affairs Department. He/She will follow the project starting from the input, which could be a new product dossier or a change implementation in an approved dossier, until the submission of the complete CMC part (Module 3 and 2.3) or specific sections. Essential tasks and responsibilities ? Collaborations with Regulatory Affairs and Technical Departments to define regulatory CMC strategies and identification of potential regulatory risks.? Identification of the required documentation for CMC submissions and negotiation with the Technical Departments of the approved technical data and documents delivery.? Review of post-approval CMC changes (Change Controls) and assessment of the regulatory impact on the affected dossiers in collaboration with Regulatory Affairs. Definition of the regulatory strategies for variation and preparation of the concerned CMC section.? Planning and preparation of CMC documentation for both new product registration and variation applications.? Collecting the responses to inquiries from Regulatory agencies on CMC content of regulatory submissions.? Preparation of meeting materials and attending to Health Authority advice related to CMC drug development activities and submissions.? Responsible to identify critical CMC/CMC regulatory issues, drive strategies and implementation for their resolution.? Able to drive cross functional scientific/technical expertise in pharmaceutical development and sound knowledge of worldwide regulatory guidelines to proactively drive cross functional CMC content, in close collaboration with development project management and technical functions. Required skills and core competences ? Bachelor's degree in a scientific discipline (Chemistry, Industrial Chemistry, Pharmaceutical Chemistry)? +5 years of experience in scientific/ technical line functions (e.g., upstream/ downstream/ analytical or drug product development)? Experience in eCTD CMC Part (Module 3 and 2.3) compilation and management? Knowledge of EU/US/Swiss regulations related to the eCTD CMC Part (Module 3 and 2.3) and guidelines related to manufacturing equipment, process validation, stability and photostability studies, elemental impurities, extractable & leachable, analytical methods validation.? Substantial work experience in analytical development, scale-up manufacturing process, preferably with cGMP experience.? Knowledge of CMC requirements for regulatory filings and working in a matrix organization highly desired.? Good experience in the use of MS software and documental tools.? Very good English communication and writing skills. The knowledge of French will be considered an asset.? Excellent communication skills, proactivity, autonomy, precision, teamwork attitude, excellent planning skills, good stress management? Management and organizational skills, flexibility, learning agility and strategic thinking.? Ability to work effectively within a cross-functional team.? Flexible to work simultaneously on multiple projects, able to adjust CMC plans to deal with changes and obstacles.? Commitment to continuous improvement.? Adaptability to a multicultural environment.   We offer Fulltime permanent employment in a young working environment and positive culture.Sintetica promotes diversity and gender equality.

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09/08/2021

Quality control laboratory coordinator

Sintetica SA
Switzerland, Ticino, Mendrisio - Sintetica SA
Pharmaceutical
Quality Control

Established in 1921 in Switzerland, Sintetica is now in its first century of activity and growth. Leader in its field in Switzerland, Sintetica is a pharmaceutical company delivering injectable anesthetics and analgesics to patients all over the world through innovative solutions with excellence in development, production, and marketing.People are our most valuable asset therefore patients, as well as the quality of our products, are at the heart of our business. That is why we believe in the Great Place to Work culture that promotes creativity and informed risk-taking in an exciting and comfortable work environment. To strengthen our Quality Control Team, we are currently looking for a Quality Control Laboratory Coordinator.   Position summaryIn a context of growth and renewal, the Quality Control (QC) Laboratory Coordinator will have to coordinate the activities assigned to the laboratory by interfacing with the various operational departments and, in collaboration with the Industrial Automation, Engineering, Digital Affairs and Site Quality Assurance Departments, will have to manage the structural implementation of the new QC laboratory, the installation and qualification of new instruments, the classification of the new premises, the transfer of instruments from the old to the new laboratory in parallel with the implementation of computerised systems (LIMS). Finally, he/she will have to manage the operational staff of the QC laboratory.   Essential tasks and responsibilitiesThe QC Laboratory Coordinator will:? Coordinate control activities on incoming materials and raw materials, processes and finished products;? Supervise control operations by verifying compliance with procedures.? Draw up sampling instructions and control methods, verifying that they are official or validated. If these are carried out by an external laboratory, supervise their performance and results.? Ensuring that laboratory operational records (paper or digital) are true, accurate and in accordance with the instructions given.? Arranging routine and extraordinary maintenance work on the instrumentation in the areas under his/her responsibility with the relevant personnel/agencies (external companies).? Planning checkpoints with respect to the management of personnel working in the laboratory.? Verifying analytical data relating to batches produced, issuing and approving certificates of analysis.? Developing and setting up microbiological and chemical/physical control methods as well as planning and managing validation studies relating to the QC department.? Supporting and collaborating with the management of strategically important projects for the company from both a documentary and an operational point of view.? Supporting the Project Leader in the implementation of the LIMS.   Required skills and core competences? Degree in a scientific discipline (chemistry, biology, pharmaceutical or related discipline).? At least 8 years' experience as a senior technician and 2 years' experience as laboratory coordinator/manager in the Quality Control department of a pharmaceutical company.? Excellent experience in personnel management.? Leadership, open-minded and innovative approach.? Ability to manage multiple projects by planning activities and adherence to timelines.? Digital and innovation orientation.? Experience in implementing a LIMS laboratory will be considered an asset.? Excellent knowledge of spoken and written English, French will be considered an asset.   We offerFulltime permanent employment in a young, dynamic work environment and positive culture.Sintetica promotes Diversity and Gender Equality.

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15/07/2021

Pharmacovigilance project manager

Sintetica SA
Switzerland, Ticino, Mendrisio - Sintetica SA
Pharmaceutical
Project / Program Management

Established in 1921 in Switzerland, Sintetica is a pharmaceutical company delivering injectable anesthetics and analgesics to patients worldwide, through innovative science and excellence in development, production and marketing. Our people are the biggest asset. That is why we believe in the great place to work culture that promotes creativity, informed risk-taking, an exciting environment and a good feeling in every day work. To strengthen our Pharmacovigilance Team at our headquarter in Mendrisio (Switzerland), we are currently looking for a Pharmacovigilance Project Manager (fulltime position).   Position summary Under the supervision of the Drug Safety Manager, the Pharmacovigilance Project Manager will provide general support for the maintenance and continuous improvement of the Pharmacovigilance (PV) System. He/she is responsible for leading and managing our global/regional partners and PV service provider/s. He/she will ensure compliance with company procedures, national and international regulations/standards/guidelines for PV.   Essential tasks and responsibilities - Acting as the primary contact point for Global/regional project-related matters. - Oversight maintenance of clients and vendor/s; monitoring the current status and results of delegated activities also through the implementation of dedicated KPIs. - Guarantees the participation in strategic activities performed by external providers (e.g. audit, selection of local providers in EU and extra EU, etc) in order to implement a documented method to assure oversight of the PV service providers. - Monitor and manage the workflow for assigned projects to ensure all deadlines are met and compliant safety reporting in accordance with international reporting regulations, Standard Operating Procedures (SOPs) and local PV documents. - Project activities planning. - Drafting of company PV agreements with partners; maintenance of Company's agreement archive to guarantee adherence to the contracts and to PV obligations. - Conduct reconciliation activities with partners according to information sources and agreement in place. - Maintenance of adverse event reporting in all countries. Responsible for making decisions regarding adverse event reporting within the local guidelines in collaboration with local responsible persons. - Provide oversight of the receipt and processing of all adverse event reports/ expedited safety reports coming either spontaneously from any source or from a clinical trial for assigned projects. This might include, but is not limited to, executing routine quality review of AE reports, ensuring that case processing and data quality meet global regulatory compliance needs. - Supports development, implementation and ensures compliance of PV procedures such as SOPs, Work Instructions (WIs) and guidelines, escalating any deviation from procedure when required. - Provide support to the team activities for case processing and maintenance of Global Safety database. - Knowledge of Eudravigilance database and related tools for submission and signal detection. - Contribute to the development and maintenance of the company's main documents: Pharmacovigilance Site Master File (PSMF), Risk Management Plan (RMP), signal detection reports, aggregate reports (PSURs, DSURs etc.).   Required skills and core competences - Degree in health sciences discipline (e.g. pharmacist, Pharmaceutical Science or related disciplines). - At least 6 years' pharmacovigilance experience. - Deep knowledge of pharmacovigilance legislation and regulations (CH/EU/GCC/LATAM). - Work experience in a pharmaceutical company. - Fluent in written and spoken English. - Experience with the use of safety databases and Eudravigilance tools. - Preferably regulatory knowledge. - Organizational skills and PV project management skills. - Strong communication skills. - Proactivity, autonomy, precision, good teamwork skills, excellent planning skills, meeting deadlines, good stress management, ability to cope with tight schedules. - Ability to prioritize and to be flexible and receptive in changing process demands. - Commitment to continuous improvement.   We offer Fulltime permanent employment in a young working environment and positive culture. Sintetica promotes diversity and gender equality.

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15/07/2021

Regulatory affairs specialist

Sintetica SA
Switzerland, Ticino, Mendrisio - Sintetica SA
Pharmaceutical
Research and Development

Established in 1921 in Switzerland, Sintetica is now in its first century of activity and growth. Leader in its field in Switzerland, Sintetica is a pharmaceutical company delivering injectable anesthetics and analgesics to patients worldwide through innovative solutions with excellence in development, production and marketing.People are our most valuable asset and our values put the patient and the quality of our products at the heart of our business. That is why we believe in the Great Place to Work culture that promotes creativity and informed risk-taking in an exciting and comfortable work environment.To strengthen our Regulatory Affairs Department at our headquarter in Mendrisio (Switzerland), we are currently looking for a Regulatory Affairs Specialist (fulltime position).   Position summary The Regulatory Affairs Specialist will provide regulatory support to ensure regulatory compliance and obtain national and international authorizations and their lifecycle maintenance under the direct control of a supervisor. He/She will join the Regulatory Affairs RoW Team managing registrations and maintenance in Third Countries through interactions with local partners.   Essential tasks and responsibilities - Support the preparation, submission, and maintenance of world-wide product registrations in the main global markets, with a focus on RoW Countries. - Critically and autonomously prepare/revise the regulatory documentation for registration purposes (MAA, variations, renewals, etc.) intercommunicating with internal departments, local partners/MAHs, and external consultants. - Constantly remain updated on new regulations issued by HAs and other regulatory organizations. - Review product labeling for compliance with global labeling regulations. - Ensure the registration documents are prepared and kept updated according to the regulatory requests of each relevant Health Authority. - Collaborate with the Quality Assurance and Pharmaceutical Development department to assess the regulatory impact of Change Controls according to the internal SOP. - Ensure that the Company products' national texts are regularly updated and uploaded to national databases, where necessary, either directly or through local partners or consultants. Knowledge and Skills - Master's degree in a scientific discipline (Pharmaceutical Science, Chemistry, Biology). - At least 6 years' regulatory affairs experience. - Deep knowledge of pharmaceutical legislation and regulations. - Experience in EU registration procedures (MRP/DCP MAA, post approval changes, extensions, and renewals). - Preferably previous experience with global registrations and CMC (quality part of the dossier) knowledge. - Organizational and regulatory project management skills. - Very good English communication and writing skills (knowledge of French or German would be an asset). - Ability to understand and communicate regulatory information. - Strong communication skills, both oral and written. - Proactivity, autonomy, precision, good teamwork skills, excellent planning skills, meeting deadlines, good stress management, ability to cope with tight schedules. - Cultural awareness and sensitivity to achieve results across regional, national, and international borders. - Ability to work effectively within a cross-functional team. - Able to work independently and complete assigned tasks within established deadlines. - Analytical thinker with strong problem-solving skills and strong attention to detail. - Commitment to continuous improvement.   We offer Fulltime permanent employment in a young, dynamic work environment and positive culture.Sintetica promotes Diversity and Gender Equality.

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30/06/2021

Regulatory affairs development manager

Sintetica SA
Switzerland, Ticino, Mendrisio - Sintetica SA
Pharmaceutical
Research and Development

Established in 1921 in Switzerland, Sintetica is now in its first century of activity and growth. Leader in its field in Switzerland, Sintetica is a pharmaceutical company delivering injectable anesthetics and analgesics to patients worldwide through innovative solutions with excellence in development, production and marketing. People are our most valuable asset and our values put the patient and the quality of our products at the heart of our business. That is why we believe in the Great Place to Work culture that promotes creativity and informed risk-taking in an exciting and comfortable work environment. To strengthen our Regulatory Affairs Department at our headquarter in Mendrisio (Switzerland), we are currently looking for a Regulatory Affairs Development Manager (fulltime position).     Position summary Sintetica is facing a huge transformation which impacts its structure, strategies, culture, policies, and technology. The new Company policy will bring to embrace new business opportunities that go beyond anesthetic and analgesic therapeutic area. New policy of product acquisition, aimed to widen the Company portfolio, implies the creation of a Task force engaged in due diligence to evaluate regulatory risks and opportunities in the concerned worldwide markets. This new direction together with the increasing number of registration applications triggers for a re-design of the Regulatory Affairs department to bring in highly experienced people with new competencies and talents to manage increased complexity of projects and to deliver successful results, contributing effectively to the Company growth. The candidate will report directly to the Corporate Regulatory Affairs Manager and supervise and mentor the Regulatory Team. He/She will also collaborate with the various internal functions external stakeholders (CMOs, commercial partners, etc.).     Essential tasks and responsibilities With the support of the Regulatory Affairs Team and with the aim of promoting the team members' individual growth, the responsibilities include: - Establishing a strategy from development to registration and supporting the execution (directly and/or through supervising the operational resources) of the global regulatory affairs lifecycle and manage approved registrations through collaborating with the various internal and external stakeholders (CMOs, commercial partners, etc.). - Overseeing development projects and performing Due Diligence activities to evaluate regulatory risks and opportunities. - Identifying in advance potential hurdles that might impact the regulatory success of development activities and/or potential licensing in processes. - Supporting the Regulatory Corporate Manager in IND, NDA, and ANDA strategy preparation, involving and training the RA Team members responsible for operational activities. - Providing operational support with strategic regulatory documents to help drive timely deliverables. - Coordinating and driving team meetings to ensure quality and timely responses to health authority queries. - Securing global submission plans together with the main area Project Manager and ensuring these plans can be executed on time. - Supervising the marketing application submission team (EU/CH/US and RoW), helping to develop strategy and content for global dossiers. - Translating regulatory requirements into practical workable submission plans. - Supervising the resources currently managing patents and trademarks by navigating the relevant multiple legal domains in pharmaceutical research, development, and innovation. - Remaining constantly updated on pharmaceutical regulations and sharing knowledge within the RA team members to promote their growth.     Required skills and core competences[] - Solid scientific background (BSc, MSc, PhD, PharmD, in life sciences, chemistry, pharmacy, medicine). - At least 15 years' experience in regulatory affairs preferably in global/HQ positions and/or across different geographic locations. - Deep knowledge of drug development processes, European regulations, FDA regulations and procedures. - Consolidated Experience in performing due diligence activities in early and late-stage product development (EU/US, mainly) and in pre-submission meetings with HAs (FDA, EMA and EU HAs) to define regulatory strategy for NDA, centralised, and decentralised procedures. - Previous experience in intellectual property protection regulatory management in the pharmaceutical industry and in development and submission strategies for emerging countries (e.g., China, India, Russia, Brazil…) would be a plus. - Excellent level of written and spoken English. - Strong leadership skills, including the ability to set goals, provide constructive feedback, build positive relationships, and improve business results. - Indirect or direct people management experience. - Autonomous, efficient, proficient in project management, precise and detail oriented. Able to handle multiple projects with good prioritization skills. - Confident in using Project, Excel, and Power Point to present project planning and Gantt charts.     We offer Fulltime permanent employment in a young, dynamic working environment and positive culture. Sintetica promotes Diversity and Gender Equality.

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30/06/2021
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