Sanofi Pasteur, the vaccines division of Sanofi, is the largest company in the world devoted entirely to human vaccines. Our driving goal is to protect people from infectious diseases by creating safe and effective vaccines. Our company distributes more than 1 billion doses of vaccine each year, making it possible to vaccinate more than 500 million people across the globe. Sanofi Pasteur offers the broadest range of vaccines in the world, providing protection against 20 bacterial and viral diseases.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
- The Regulatory CMC Conformance Product Focal Point (PFP) is a motivated and results driven individual that has the responsibility of one or several drug substances (antigens) in the Reg CMC Conformance Group. The PFP develops the drug substance CMC submission strategy and is responsible for managing all the regulatory CMC aspects throughout the life cycle of the drug substances he/she has in charge from development through post licensure.
- The PFP provides support to RA R&D and represents RA on IA project teams when drug substance-related regulatory CMC expertise is required.
- An PFP can also be mandated to lead a transversal regulatory project (such as coordination of a variation impacting several products/drug substances), or one submission in a given country, where all product/drug substance/facility/equipment related activities justify several PFPs.
- The PFP could be mandated by the manager to organize and lead contacts with regulatory agencies, or third parties regarding CMC submissions and/or activities.
- As per the assignment, the PFP, develops the regulatory CMC strategy for products/drug substances/facilities/equipment/projects. The PFP:
- Compiles all the relevant information necessary to support the best regulatory CMC strategy for registration of a new vaccine, or a license update in all concerned countries.
- Develops the Global Regulatory CMC Strategy Document (GRCSD) when applicable and keeping the document updated throughout the life of the products/drug substances/facility/equipment/project. Ensuring the coordination with the different areas concerned.
- Performs change control assessment of the proposed changes by IA for Canada, US and Europe and prepares the GRCSD and implementation plan with a global view for the impacted products/drug substances/facilities/equipment.
- Marketing applications, related amendments or variations and all routine license maintenance activities and support for products in all phases of development. For new marketing applications, the PFP coordinates the creation of the module 2.3 and module 3 Common Technical Documents (CTD) for filing in the targeted countries. As per the assignment, the PFP:
- Executes and implements the defined regulatory strategy via relevant CMC submissions
- Prepares and coordinates the creation of the CMC documents in support of complete license applications (MAA, BLA, etc.) and other regulatory submissions for regulatory agencies and/or third parties
- Authors, reviews and approves CMC related documents/summaries and provides editorial review for all CMC of regulatory applications and submissions
- Ensures preparation of the CMC components of the submission within pre-defined schedules in accordance with relevant RA procedures, tools and templates and coordinates the final submissions
- Anticipates any delays in pre-defined submissions, finds the root cause, sets-up corrective action plan and/or proposes alternate solutions
Organizational Reporting and Communication:
- PFP is responsible for reporting on progress and specific issues pertaining to product/drug substance/facility/equipment/project CMC responsibilities.
As per the assignment, the PFP will work jointly with IA groups and project managers for the planning and coordination of regulatory CMC activities relating to products/drug substances/facilities/equipment/projects from initiation to approval, which includes:
- Detailed plan prioritization and coordination of activities
- Developing CMC related regulatory objectives and target dates
- Providing timelines for critical CMC regulatory activities to be incorporated into the project plan.
- Health Authority (HA) Contacts and Communications
As per the assignment, the PFP manages contacts with regulatory agencies or third parties related to CMC issues:
- Responsible for the notification and recommends the inclusion of the most appropriate individuals within the company based upon the criticality of the issues to be addressed.
- Discusses and may negotiate issues with regulatory agencies/third parties. Communicates, documents and archives information for the organization.
- Responsible for notification to relevant functional areas and impacted project team(s) and individuals regarding communications/feedback from regulatory agencies.
- Sets up the necessary meetings with regulatory agencies/third parties and co-ordinates the preparation of the pre-reads and the presentations.
Health Authority (HA) Commitments and Documents:
- Responsible for timely and accurate tracking of CMC related regulatory agency requests and commitments and to manage completion.
Health Authority (HA) Inspection Preparation/Support and Other RA Process Development Support:
- Participates and provides support in inspection preparation and inspections, as requested.
- Provides product/drug substance/facility/equipment/project-related input and resources towards the development and implementation of new RA systems, procedures and/or tools.
Responsible for providing regulatory CMC advice and guidance to product/drug substance/facility/equipment/project team members and other functional areas on regulatory matters:
- Provides information from regulatory requirements and documents and other appropriate guidance documents
- Provides training and education/guidance on regulatory policies, procedures and other regulatory documents in collaboration with Regulatory Operations and Regulatory Quality & Continuous Improvement (Q&CI)
- Responsible for staying up-to-date on regulatory guidances and technical/scientific developments. Assesses impact on areas of product/drug substance/facility/equipment responsibilities, communicates to the organization and, comments on draft regulations and assesses future areas for influencing the regulatory environment. The PFP may participate in management of RA staff, including development, coaching and performance appraisal of staff, as appropriate.
Education & Experience
- BA/BS, Pharm D, or DVM or MSc in Biology, Life Science or a related field of study; 3-5 years prior Regulatory Affairs experience.
- Demonstrated knowledge of microbiology, immunology, virology or bacteriology.
- Experience working on project teams preferred.
- Ability to manage multiple priorities efficiently.
- Requires in depth knowledge and understanding of the North American, European and International regulations/guidelines.
- Good skills in communication and teamwork.
Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request.
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