Associate Director, Regulatory Affairs - Biosimilars (US)

Job Description Summary

The Associate Director, Regulatory Affairs – Biosimilars (US) leads U.S. regulatory strategy and execution for biosimilar development and marketed products. The role serves as the U.S. regulatory lead for assigned biosimilar assets, delivering strategic direction, FDA interactions, and hands‑on regulatory submission oversight, partnering cross‑functionally to secure timely approvals and maximize lifecycle value while ensuring compliance with U.S. regulatory requirements.

Location

This position is located at the Princeton, NJ U.S. Headquarters site. Employees must be office‑based (up to 50% of the monthly workday can be remote). The role is not eligible for remote work or U.S. work‑visa sponsorship.

Responsibilities

• Lead and manage the preparation, review, and submission of regulatory applications, including product registrations, progress reports, supplements, amendments, and periodic experience or safety reports.
• Provide regulatory strategy and guidance to cross‑functional development and project teams, contributing to evidence generation and regulatory positioning to support product approvals.
• Serve as a key regulatory liaison throughout the product lifecycle, interacting with regulatory agency personnel to address inquiries, negotiate requirements, and facilitate timely review and approval of submissions.
• Support maintenance of approved status for marketed products and contribute to the approval of new drugs, biologics/biotechnology products, and/or medical devices.
• Represent Regulatory Affairs on research, development, and marketing project teams, ensuring regulatory considerations are integrated into development and commercialization plans.
• Advise internal stakeholders on regulatory implications of manufacturing changes, line extensions, labeling updates, and regulatory interpretations.
• Coordinate and review regulatory documents and, as needed, author submission components to ensure compliance with applicable regulations and alignment with business objectives.
• Develop and lead U.S. regulatory strategies for biosimilar programs from early development through post‑approval lifecycle management.
• Serve as the regulatory subject‑matter expert on U.S. biosimilar regulations, guidance, and evolving FDA expectations.
• Oversee 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 U.S. 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 U.S. pre‑ and post‑approval filing, reporting, and regulatory obligations.
• Represent U.S. Regulatory Affairs at internal (U.S. and global) governance forums and external meetings with regulatory authorities and partners.

Key Capabilities

• Regulatory & Compliance Expertise – advanced knowledge of global health authority regulations and guidance across drug development, labeling, and post‑marketing compliance.
• Project & Portfolio Management Expertise – lead and oversee complex regulatory portfolios and prioritize multiple concurrent projects across development stages.
• Communication & Interpersonal Skills – strong communication and influencing skills to engage and align diverse stakeholders.
• Analytical & Problem‑Solving Skills – apply analytical and strategic thinking to evaluate regulatory challenges, identify risks, and develop mitigation approaches.
• Strategic Leadership & Vision – shape and execute forward‑looking regulatory strategies aligned with broader business objectives.

Qualifications

• Required – Bachelor's degree in Life Sciences (Biology, Pharmacy, Chemistry, Biotechnology, or related field); advanced degree (MS, PhD, PharmD) preferred; minimum 7 years regulatory affairs experience within the biopharmaceutical industry with U.S. 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.
• Preferred – strong organizational skills with the ability to manage multiple priorities; experience in a global regulatory environment and collaboration with ex‑U.S. regulatory teams.

Benefits

• Competitive salary in the range $145,600 – $279,400 USD per year (base). Final pay may be adjusted based on various factors.
• Generous medical, prescription drug, dental and vision insurance coverage.
• Company match for retirement savings accounts.
• Paid time off, including vacation, sick time and parental leave.
• Potential sign‑on bonus, restricted stock units and discretionary awards.
• Hybrid work policy combining in‑person and remote work.

EEO & Accessibility Statement

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Sandoz, Inc. is committed to working with and providing reasonable accommodation to individuals with disabilities. If you need a reasonable accommodation, please email View email address on click.appcast.io or call View phone number on click.appcast.io and include the job requisition number, name and contact information.