Biosimilars Regulatory Lead (US): Submissions & Strategy

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

Benefits offered by this job

Hybrid work policy

Health insurance

Retirement match

Generous paid time off

Job summary

Sandoz invites experienced Regulatory Affairs professionals to join our Princeton, NJ headquarters in a hybrid role that supports US regulatory strategy for biosimilar programs and guides submissions and lifecycle activities.

You will lead preparation and submission of INDs, BLAs, and supplements, coordinate FDA interactions, and ensure compliant strategies enabling timely approvals and ongoing post‑market compliance.

Qualifications

• Bachelor’s degree in Life Sciences (Biology, Pharmacy, Chemistry, Biotechnology, or related field) required.
• Advanced degree (MS, PhD, PharmD) preferred.
• Minimum of 7 years of regulatory affairs experience within the biopharmaceutical industry, including hands-on experience with US biosimilar programs and BLA (351(k)) submissions.
• Strong working knowledge of FDA regulations, guidance, and processes applicable to biosimilar development and post-marketing activities.
• Demonstrated experience preparing regulatory submissions and leading FDA interactions.
• Ability to work independently while effectively influencing and collaborating within cross-functional, matrixed teams.
• Excellent written and verbal communication skills with strong attention to detail.

Responsibilities

• Develop and lead US regulatory strategies for biosimilar programs from early development through post-approval lifecycle management.
• Serve as the regulatory subject matter expert on US biosimilar regulations, guidance, and evolving FDA expectations.
• Oversee the preparation, review, and submission of INDs, BLAs (351(k)), amendments, supplements, information request responses, post-approval commitments, and annual reports.
• Lead and support FDA interactions, including Pre-IND, Biosimilar Product Development (BPD), and other regulatory and scientific advice meetings.
• Provide regulatory leadership and guidance in partnership with Clinical, Nonclinical, CMC, Analytical Development, Quality, Pharmacovigilance, Medical Affairs, Legal, and Commercial teams.
• Manage post-approval US regulatory activities, including labeling updates, safety-related submissions, manufacturing and comparability changes, and inspection readiness support.
• Partner with global development and technical operations teams to ensure high-quality BLAs, amendments, and supplements that meet FDA requirements.
• Ensure ongoing regulatory compliance with US pre- and post-approval filing, reporting, and regulatory obligations.
• Represent US Regulatory Affairs at internal (US and global) governance forums and external meetings with regulatory authorities and partners.

Skills

Regulatory strategy

Cross-functional collaboration

FDA interactions

Project leadership

Regulatory communications

Education

Bachelor’s degree in Life Sciences

Advanced degree preferred

Job description

Sandoz invites experienced Regulatory Affairs professionals to join our Princeton, NJ headquarters in a hybrid role that supports US regulatory strategy for biosimilar programs and guides submissions and lifecycle activities.

You will lead preparation and submission of INDs, BLAs, and supplements, coordinate FDA interactions, and ensure compliant strategies enabling timely approvals and ongoing post‑market compliance.