(Senior Director) North America Regulatory Affairs Therapeutic Lead – Immunology/Neurology
Cambridge, Massachusetts, Bridgewater, New Jersey
The North America Therapeutic Lead for Immunology/Neurology will be primarily responsible for the development of US regulatory strategy to advance Sanofi’s Immunology and Neurology portfolios 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 Immunology and Neurology portfolios. 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 Immunology and Neurology indications which adhere to US regulatory and company guidelines.
- Have an understanding of the regulatory environment for the various 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 immunology or neurology therapeutic areas
- 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
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.
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