Associate Director, Regulatory Affairs - Biosimilars (US)

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.
• Major Accountabilities / Your Key Responsibilities:
• Key Performance Indicators:
• Successful implementation of global regulatory strategy for timely submissions and approvals with the best possible labels based on available data.
• Identification of main HA issues -Participation in relevant regulatory Boards leading to valuable input from these Boards.
• Successful Participation in HA interactions to achieve business objectives.
• Adherence to Sandoz policy and guidelines -Project & stakeholder feedback
• Key Capabilities Required:
• Regulatory & Compliance Expertise
• Project & Portfolio Management Expertise
• Leads and oversees complex regulatory portfolios, effe

Benefits

Additional Information

Job Description Summary The Associate Director, Regulatory Affairs - Biosimilars (US) is responsible for leading US regulatory strategy and execution for biosimilar development programs and marketed products. This role serves as the US regulatory lead for assigned biosimilar assets, providing strategic direction, leadership in FDA interactions, and hands on oversight of regulatory submissions. The position partners cross functionally to enable timely approvals and maximize lifecycle value while ensuring compliance with US regulatory requirements. Job Description Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape! Position Location: This position will be located at the Princeton, NJ US Headquarters site. Our Sandoz flexible hybrid working approach allows US office-based employees to work up to 50% of their monthly workday remotely. This role will not have the ability to be located remotely. Must be authorized to work in the U.S. U.S. work visa sponsorship is not available for this role now or in the future. Job Description: Leads and manages the preparation, review, and submission of regulatory applications, including product registrations, progress reports, supplements, amendments, and periodic experience or safety reports. Provides regulatory strategy and guidance to cross‑functional development and project teams, contributing to evidence generation and regulatory positioning to support product approvals. Serves 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. Supports the maintenance of approved status for marketed products and contributes to the successful approval of new drugs, biologics/biotechnology products, and/or medical devices. Represents Regulatory Affairs on research, development, and marketing project teams, ensuring regulatory considerations are integrated into development and commercialization plans. Advises internal stakeholders on regulatory implications of manufacturing changes, line extensions, labeling updates, and regulatory interpretations. Coordinates and reviews regulatory documents and, as needed, authors submission components to ensure compliance with applicable regulations and alignment with business objectives.

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