Job title:Product Focal Point

About the job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

Within the “GRA Regulatory CMC & Devices (Vaccines)” department, the Product Focal Point (PFP) is responsible for managing a portfolio of projects and/or marketed products. The PFP is responsible for the global CMC regulatory strategy definition, managing variation approvals and questions as well as direct interactions with the Health Authorities.

The PPF works closely with Global Regulatory Affairs (GRA), Regions (“Regional GRA”), local regulatory teams, quality groups within R&D and Industrial Affairs, including in particular the RSO (Regulatory Site Officer) teams, with partners but also with Human Resources, Legal Services, Finance or Health Authorities.

The PFP is also involved in internal or external programs/organizations leaded by Sanofi and ensures representation of the company by demonstrating the values of Sanofi and Global Regulatory Affairs.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main responsibilities:

• Develop CMC regulatory strategies and assess associated risks for development projects and/or registered products (new products or marketed products) in collaboration with all Global Regulatory Affairs entities

• Participate in Change Control assessment

• Guarantee strong collaboration within CMC teams for the implementation of defined regulatory strategies

• Ensure that for CMC activities with a major regulatory and/or financial impact, appropriate strategies are implemented, risks are identified, communicated and taken into account

• Ensure that requests from Health Authorities are taken into account in an effective and timely manner. Develop lasting relationships with the Health Authorities

• Provide the necessary support for strategic negotiations with the Global Health Authorities, including the FDA (US) and the EMA (Europe), to take pragmatic decisions with the greatest probability of success

• Draft or contribute to the drafting, preparation, review and approval of supporting documents for consultation with health authorities in order to define the future submission strategy; in collaboration with R&D functions, Industrial Affairs, Global Regulatory Affairs

• Coordinate the submission of CMC regulatory files and contribute to the preparation and review; in collaboration with R&D functions, Industrial Affairs, Global Regulatory Affairs. To ensure the monitoring and management of post-approval commitments in connection with CMC activities

• Ensure that variation files are prepared in accordance with requirements, quality standards and within the time allotted

• Author the CMC strategy document “Global Regulatory CMC Strategy Document” in connection with the Blue Print model if applicable

• Ensure that CMC regulatory issues are considered and resolved optimally

• If applicable, support the regulatory inspection process

• Contribute to Sanofi initiatives, review of local and international regulations and guidelines. Ensure that the requirements of the Health Authorities are taken into account and communicated

About you

Experience:

• Operational experience within an organization (medium to large) in Regulatory CMC department

• Knowledge of global regulations/guidelines; Health Authorities, their modes of operation and their expectations. Ability to solve strategic technical and regulatory problems. (3-5 years of experience in Regulatory department)

• Demonstrate initiative, reflection, foresight and the ability to communicate effectively with internal or external partners

Education:

• BS/BA degree in a relevant scientific discipline required. Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field) preferred

Why choose us? 

• Bring the miracles of science to life alongside a supportive, future-focused team

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs

PursueProgress. Discover Extraordinary.

Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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