Biosimilars Regulatory Lead (US)

Sandoz; Princeton (NJ); Hybrid; USD 146,000 - 279,000; Full time

Job summary

Sandoz, located at Princeton, NJ, seeks an Associate Director of Regulatory Affairs for Biosimilars. The role leads US regulatory strategy across biosimilar programs from development through post‑approval lifecycle, interfacing with FDA and cross‑functional teams to ensure timely submissions and approvals.

The position supports labeling updates, post‑approval commitments, and regulatory governance within a hybrid work environment.

Qualifications

• Lead preparation, review, and submission of regulatory applications (registrations, supplements, amendments, post‑approval reports).
• Provide regulatory strategy and guidance to cross‑functional teams for approvals.
• Represent Regulatory Affairs with agencies to address inquiries and facilitate submissions.

Responsibilities

• Develop and lead US regulatory strategies for biosimilar programs through lifecycle.
• Serve as regulatory SME on US biosimilar regulations and FDA expectations.
• Oversee INDs, BLAs (351(k)), amendments, supplements and information requests.
• Lead FDA interactions (Pre‑IND, BPD, and other meetings).
• Provide regulatory leadership with Clinical, Nonclinical, CMC, and other teams.

Skills

Regulatory strategy

US biosimilar regulations

FDA interactions

Cross-functional collaboration

Regulatory submissions

Strategic leadership

Education

Bachelor’s degree in Life Sciences

Advanced degree (MS/PhD/PharmD) preferred

Job description

Sandoz, located at Princeton, NJ, seeks an Associate Director of Regulatory Affairs for Biosimilars. The role leads US regulatory strategy across biosimilar programs from development through post‑approval lifecycle, interfacing with FDA and cross‑functional teams to ensure timely submissions and approvals.

The position supports labeling updates, post‑approval commitments, and regulatory governance within a hybrid work environment.