Quality/Risk Management, US Regulatory Affairs, Worldwide Regulatory Affairs
This position has multiple locations: Marcy-l'Etoile;Toronto, ON;Swiftwater, PA
Global Regulatory Team Lead (GRTL) is responsible for developing the global regulatory strategy for the project or projects in his/her remit. In this capacity, the GRTL has regulatory accountability globally for the program, working with the Global Regulatory sub-team (regions, Regulatory CMC, Regulatory Operations, labeling) to develop and execute robust regulatory strategies and drive business objectives.
Represents Global Regulatory Affairs (GRA) as a member of the cross-functional project team and Brand team. In this capacity, the GRTL is the single point of contact for the business and R&D on regulatory issues for the project. The GRTL provides regulatory advice and strategy for the project(s) and ensures the timely execution of regulatory activities.
Manages the Global Regulatory project sub-team(s). Ensures effective communication between cross-functional project team and regulatory sub-team; oversees the planning and execution of global regulatory activities and submissions. This includes ownership of a GRT (Global Regulatory Team).
Ensure the development of robust global regulatory strategies for the program and is accountable for developing and maintaining a regulatory strategy document (GRPS). The regulatory strategy addresses the Target Product Profile, regional specific needs, regulatory environment, regulatory risks and mitigations, global submission strategies, and reimbursement strategies. The GRTL will work with the global regulatory sub-team to ensure relevant input from all GRA functions is vetted and included in the regulatory strategy framework.
Responsible for developing regulatory strategy information for presentation during leadership governance meetings. The GRTL is accountable for ensuring GRA Sr. Management alignment with strategy, risks and mitigation and for presenting a unified regulatory voice.
The GRTL is responsible for ensuring communications from HAs and meetings with HA are fully supported. In addition that minutes are disseminated in a timely manner and properly interpreted, to the project teams, the business unit, and GRA Sr. Management.
Provide regulatory due diligence assessments of new business opportunities as required.
7-10 years pharmaceutical industry experience in R&D, Regulatory or related functions, with at least 5 years working in regulatory affairs (regionally or globally). Regulatory lead experience in the US or EU. BA/BS in a scientific discipline or related field of study.
Advanced degree preferred.
Experience with at least one major marketing application (NDA/BLA/MAA/JNDA etc.) our extensive experience with late-stage development/marketed products.
Licensed product knowledge and experience with post-approval changes is also desired.
Knowledge, Skills and Other Experience:
Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance.
Experience / Exposure to vaccines is desired.
Direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA, BGTD).
Strong strategic skills including the ability to make complex decisions and willingness to defend difficult positions.
Excellent operational skills including planning, organizing and ability to motivate and lead others.
Ability to work well within cross-functional teams.
Demonstrate solid oral communication and writing skills.
Understanding of the Global pharmaceutical market place and familiarity with medical terminology. Understands issues, problems, and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution.
Develops collaborative relationships to facilitate the accomplishment of work goals.
Generates innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities.
Shows the ability to use appropriate interpersonal styles and techniques and can modify behavior to gain acceptance of ideas or plans.
Can build networks to obtain cooperation without relying on authority
Strong sensitivity for a multicultural/multinational environment.
Internal Number: R2525155
Sanofi, a global healthcare leader, discovers, develops, and distributes therapeutic solutions focused on patients' needs. With 12 locations in Massachusetts, many located within close proximity to Boston, you'll have easy access to public transportation, popular restaurants, some of the best education, and most of all the history.