Multiple Locations: Bridgewater, NJ; Cambridge, MA
The North America Therapeutic Lead Oncology will be primarily responsible for the development of US regulatory strategy to advance Sanofi’s Oncology portfolio of development pipeline candidates and life cycle management of marketed products. Reporting to the Sanofi Genzyme Associate Vice President of North America Regulatory Affairs, this individual will work within the Global Regulatory Team to provide strategic input and ensure operational execution of US submission activities for the Sanofi Genzyme Oncology portfolio. The individual will be responsible to interface directly with the US FDA as the primary contact for the company for assigned programs and lead a small team of North America Regulatory Leads (NARLs). The position may be based at either Bridgewater, NJ or Cambridge, MA.
Specific Responsibilities Include
Responsible to proactively develop innovative, robust US regulatory strategies and ensure their efficient and effective execution for pipeline and lifecycle assets in clinical development for Oncology indications which adhere to US regulatory and company guidelines.
Have an understanding of the regulatory environment for the various oncology indications and support NARLs in developing products that are differentiated.
Represent the NA GRA perspective as a member of project specific cross functional global regulatory team (GRT) and be accountable to develop and maintain US aspects of regulatory strategy documents.
Lead the strategic development of briefing materials and prepare teams for US FDA meetings.
Accountable to define document content/strategy to align with US regulatory expectations.
Participate in the development of and assess the appropriateness of submission documentation to support successful INDs/NDAs/BLAs.
Represent Sanofi at US FDA for assigned projects.
Work with the NA labeling strategist, Global Regulatory Team Leads, Global Regulatory Therapeutic Head and the Global Regulatory Team to develop US prescribing information.
Work with and participate on multi-disciplinary matrixed teams to successfully meet project US regulatory deliverables while adhering to regulatory requirements for programs and products.
Consult with senior management to develop and communicate US regulatory strategies and advice for products and programs.
Participate in the development and monitoring of the US regulatory environment and updating of standards and processes related to drug and biologics US regulations.
Function as a player/coach to develop high level regulatory strategies for assigned projects.
Supervise, and/or coach mentor, junior staff supporting global regulatory teams.
Ensure compliance with all regulatory and internal Sanofi policies
BS degree in a relevant scientific discipline required. Advanced degree is preferred (MS/PhD/PharmD)
15-20 years industry experience, with at least 10 years working in regulatory affairs (regionally or globally).
Delivery of a number of major applications (NDA/BLA/IND, etc…)
Experience with late stage development/marketed products
Prior experience in the oncology therapeutic area
Prior experience in managing people desired
Knowledge, Skills And Other Experience
Strong strategic skills including the ability to make complex decisions and willingness to defend difficult positions.
Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving US regulatory policy and guidance
Direct interaction/negotiation with regulatory authorities (e.g. FDA)
Ability to motivate and lead others
Team player, ability to work well within cross-functional teams and in a multicultural/multinational environment
Excellent oral communication and writing skills
Change management/ change enabler : embraces the challenges of a fast changing environment
Generates innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities
Excellent operational skills
Unquestionable ethics, professional integrity, and personal values consistent with the Sanofi values
Internal Number: R2516449
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.