Sanofi Group Head Regulatory CMC Vaccines, US in Swiftwater, Pennsylvania
The Head Regulatory CMC Vaccines is responsible for developing the global regulatory CMC strategies and CMC dossiers for IA and R&D driven projects which include Initial filings, New Market Authorizations and product changes for products manufactured at the responsible site and subcontracting sites to achieve initial approvals and to ensure all products and facilities maintain regulatory approval in compliance with current industrial and regulatory practices. These strategies identify risks and support IA and BU financial targets. The local head also provides regulatory support during regulatory inspections if appropriate. This position ensures that the group develops and maintains effective working relationships across GRA and cross-functional teams and with various regulatory agency personnel. This position drives discussions with health authorities to influence the regulatory CMC environment and CMC related guidance’s.
The local head has overall managerial responsibility of the Regulatory CMC staff at his or her site meeting the requirements for local HR processes.
Proactively participates in the CMC management team (CMC MT) to ensure effective contributions to the group and sharing of experiences and knowledge. Contributes to develop synergies between all Regulatory CMC groups globally to ensure consistent strategies and submission, follow up and approval.
Embodies a single CMC voice with common standards and practices across sites and dossiers that is geared towards maximization of IA flexibility and BU profitability.
Participates to set up global CMC processes and strategies to ensure the organizations functions in unison.
Oversees the creation and compilation of CMC dossiers for IA and R&D projects to achieve target submission dates.
Provides guidance on regulatory compliance regarding: the reporting level to Health Authorities and strategies consistently across the sites for changes as required by the CMC customers, assesses change controls to ensure appropriate reporting level is maintained.
Provides management for local RA CMC staff, including coaching, mentoring/support (technical and regulatory oversight and guidance), appraisal and development, as well as being responsible for recruitment within the function. Develops and promotes coaching and training programs to enhance both regulatory and technical expertise within the CMC group. Participates in local management of the overall site RA department. Contributes to the site and global Reg CMC Conformance function budget and operating plans. Participates in developing high quality standards within RA and participates in the development of operating procedures.
Participates (or appoints delegate) in one or more site committees or boards ensuring that the regulatory opinion is presented and the issues, actions, and concerns from and to the RA department is established and communicated.
Health Authority (HA) Inspection Preparation/Support : May participate and provide support in inspection preparation and inspections, as requested.
Education / experience
BS in science or equivalent
5 to 10 years prior Regulatory Affairs experience or relevant industry experience required
Demonstrated experience with Biopharmaceuticals
3+ years’ experience in a leadership position with demonstrated managerial and communication skills
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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.