Regulatory CMC Product Focal Point

Job description

Regulatory CMC Product Focal Point (m/w/d)

About the Opportunity

As a Product Focal Point you will be accountable for global strategic management of a portfolio of development projects and/or marketed products in the Vaccines team. Within Global Regulatory Affairs (GRA) CMC & Devices, you are responsible for regulatory CMC strategies including direct contact with Health Authorities.

In this position you collaborate with a wide range of departments such as Global and Regional Regulatory Affairs, Country Regulatory Groups, Technical and Quality Groups within R&D and Industrial Affairs, External Alliance Partners, Project Direction/Management (R&D Development, Vaccines Operations teams), Regulatory Health Authorities and others. You are also engaged in internal and external Regulatory Policy Organizations/Programs in order to develop and maintain appropriate Sanofi representation in these activities.

About growing with us

In this role you will…

·  Develop global regulatory CMC strategies and risk assessments for development projects and/or marketed products (vaccines) in collaboration with other parts of GRA (Global Regulatory Affairs). Assure that positive and collaborative relationships are developed with CMC teams to achieve the implementation of appropriate regulatory strategies. Assure that, for major CMC activities that have a critical regulatory and/or financial impact, appropriate strategies are developed to manage the activities, and risks are identified, communicated and mitigated as necessary.
·  Assure that appropriate contacts with Health Authorities, in collaboration with Country Regulatory Groups, are initiated and addressed in an effective and timely manner, whilst developing positive and favourable relationships. Support strategic negotiations with worldwide Regulatory Health Authorities so that appropriate and pragmatic positions are negotiated with the highest Probability of Success (POS).
·  Assess the impact of regulatory changes, or changes in the production process or control for development projects and/or marketed products (vaccines). Manage the CMC CTD sections writing, preparation, review and approval of the regulatory CMC dossiers for submission in collaboration with R&D Functions, Industrial Affairs Functions and GRA Regulatory Operations. Assure that submission dossiers meet appropriate quality standards; strategies and mitigated risks are developed and communicated, and deadlines are achieved. Assure that technical and regulatory CMC issues are appropriately resolved with optimal solutions. As applicable, support the regulatory inspection process for development projects and marketed products.
·  Contribute knowledge and expertise on GRA Regulatory Science and Policy activities, as well as other related internal or external policy initiatives, in order to assure that appropriate Sanofi visibility and input is recognized. Monitor the review of local and international Health Authority regulations and guidelines, contribute to the commenting process and/or develops position papers. Assure that current Health Authority thinking and trends are understood and broadly communicated.

About You

Qualifications/education & work experience: 

·  Minimum of a bachelor’s degree; advanced degree (Masters, PhD) in a science/health field (e.g., Analytical, Chemistry, Pharmacy, Biological/Biotechnology Sciences etc.), or equivalent.
·  Technical pharmaceutical CMC experience (laboratory, manufacturing, etc.). 
·  Typically, an additional 1-5 years of direct Regulatory CMC experience is preferred.
·  Global operational experience with a mid/large-size Regulatory CMC and Devices Organization. Must have some knowledge of global regulations/guidelines, key Health Authority/Industry thinking and trends.
·  Experience working for a Regulatory Health Authority is helpful but not essential.

Competencies:

·  Ability to work in multidisciplinary and multicultural environment and be capable of resolving strategic technical and regulatory issues.
·  Initiative, independent thinking, leadership skills, anticipatory foresight.
·  Expertise in planning methods and tools, ability to coordinate, organize and plan in an efficient and effective manner.
·  Ability to deal with conflicting priorities in constantly changing environment and be able to negotiate and communicate effectively to internal and external stakeholders. 
·  Fluency (oral and written) in French language is helpful but not essential.

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Inspire your Journey: what Sanofi can offer you:

·  An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team.
·  An attractive, market-oriented salary aligned with your qualifications and including social benefits above average (e.g. company pension plans, health management).
·  An individual and well-structured introduction and training when you onboard.
·  You can create your own career path within Sanofi. Your professional and personal development will be supported purposefully.
·  As a globally successful and constantly growing company, Sanofi provides international career paths as well.

This is our Sanofi. Discover yours.

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.