Regulatory Strategy Lead (Pharma)

Regeneron Pharmaceuticals, Inc (USA); Village of Tarrytown (NY); Presencial; USD 176.000 - 287.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Bonuses

Equity awards

Pension plan

401(k)

Health benefits

Paid time off

Family benefits

Descripción de la vacante

Regeneron Pharmaceuticals, Inc. is seeking an Associate Director to join the Regulatory Affairs Strategy team in the United States (Tarrytown, NY).

The role emphasizes developing regulatory strategies, liaising with FDA and other authorities, and leading crossfunctional teams to ensure timely approvals. You will oversee regulatory filings, provide guidance on BLA/MAA content, monitor new guidelines, and mentor staff while ensuring compliance across development programs and manufacturing

Formación

• MD/PhD/PharmD or equivalent advanced degree; a relevant scientific discipline is strongly preferred.
• Minimum of 10 years in the pharmaceutical industry with at least 5 years in regulatory affairs.

Responsabilidades

• Develop regulatory strategies for assigned programs in collaboration with Regeneron senior management.
• Liaison with FDA and other health authorities for assigned programs.
• Manage all regulatory activities for Regeneron drug development programs.
• Lead multidisciplinary teams and provide regulatory guidance for clinical development.
• Prepare and maintain IND/CTA filings and ensure completeness of regulatory submissions.
• Oversee development of regulatory filings in support of programs.
• Analyze data (clinical, preclinical, manufacturing) and develop interpretations.
• Review clinical protocols and study reports for regulatory clarity and completeness.
• Author and review regulatory communications and briefing packages.
• Ensure timelines and budgets are managed with project management oversight.
• Monitor new FDA guidance and international documents and provide training as needed.

Conocimientos

Communication skills

Educación

MD/PhD/PharmD or equivalent

Descripción del empleo

Regeneron Pharmaceuticals, Inc. is seeking an Associate Director to join the Regulatory Affairs Strategy team in the United States (Tarrytown, NY).

The role emphasizes developing regulatory strategies, liaising with FDA and other authorities, and leading crossfunctional teams to ensure timely approvals. You will oversee regulatory filings, provide guidance on BLA/MAA content, monitor new guidelines, and mentor staff while ensuring compliance across development programs and manufacturing