Biosimilars Regulatory Strategy Leader — Sr. Dir/VP

EPM Scientific; United States; On-site; USD 150,000 - 200,000; Full time

Job summary

A leading global biosimilars organization is seeking a Senior Director or Vice President, Regulatory Affairs, to support regulatory strategy for biosimilar products in the U.S. This strategic role involves engaging with the FDA and shaping biosimilar regulatory policies. Ideal candidates will have extensive experience in regulatory strategy, especially with biosimilars, and prior experience at the FDA. Join us to influence biosimilar adoption in the U.S. and contribute to evolving regulatory frameworks.

Qualifications

• Extensive experience in biosimilars regulatory strategy and policy.
• Prior experience at the U.S. FDA strongly preferred.
• Deep understanding of biosimilar regulatory pathways.

Responsibilities

• Serve as the primary regulatory interface with the U.S. FDA.
• Develop regulatory policy strategies to advance U.S. biosimilar adoption.
• Engage with academic institutions and policy stakeholders.

Skills

Biosimilars regulatory strategy

FDA engagement

Regulatory policy advocacy

External collaboration

Education

Advanced degree in biological sciences, pharmaceutical sciences, medicine

Job description

A leading global biosimilars organization is seeking a Senior Director or Vice President, Regulatory Affairs, to support regulatory strategy for biosimilar products in the U.S. This strategic role involves engaging with the FDA and shaping biosimilar regulatory policies. Ideal candidates will have extensive experience in regulatory strategy, especially with biosimilars, and prior experience at the FDA. Join us to influence biosimilar adoption in the U.S. and contribute to evolving regulatory frameworks.