Associate Director, Regulatory Affairs - Biosimilars (US)

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. 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 Demonstrates advanced expertise in global health authority regulations and guidance across drug development, labeling, and post‑marketing compliance. Provides strategic oversight in interpreting and applying regulatory requirements to shape submission strategies, accelerate approvals, and ensure sustained compliance throughout the product lifecycle. Project & Portfolio Management Expertise Leads and oversees complex regulatory portfolios, effectively prioritizing multiple concurrent projects across development stages. Drives cross‑functional alignment on timelines, deliverables, and strategic objectives to ensure consistent, high‑quality execution and achievement of key milestones. Communication & Interpersonal Skills Exhibits strong communication and influencing skills, with the ability to engage and align diverse stakeholders across functions and levels. Builds and sustains strategic relationships while clearly articulating complex regulatory strategies to support informed decision‑making in a dynamic, team‑oriented environment. Analytical & Problem‑Solving Skills Applies strong analytical and strategic thinking to evaluate regulatory challenges, identify risks, and develop proactive mitigation approaches. Guides decision‑making through sound judgment, data‑driven insights, and a focus on balancing compliance with business objectives. Strategic Leadership & Vision Demonstrates the ability to shape and execute forward‑looking regulatory strategies that enable successful product development and launches. Aligns regulatory initiatives with broader business objectives while driving cross‑functional collaboration, influencing key stakeholders, and ensuring proactive, business‑focused decision‑making. What you’ll bring to the role Required Qualifications Education & Experience 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. Preferred Requirements Strong organizational skills with the ability to manage multiple priorities effectively. Experience in a global regulatory environment and collaboration with ex‑US regulatory teams. You’ll Receive Sandoz offers a generous employee benefits package that includes a competitive salary, health insurance coverage for medical, prescription drugs, dental and vision, a generous company match for retirement savings accounts, and generous paid time off. We also follow a hybrid work policy that combines a mix of in‑person and remote work to allow our employees flexibility. Why Sandoz? Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more! With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low‑cost, high‑quality medicines, sustainably. Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible‑hybrid careers, where diversity is welcomed and where personal growth is supported! Join us! EEO 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. Accessibility and Reasonable Accommodations Sandoz, Inc. is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to View email address on click.appcast.io or call View phone number on click.appcast.io and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $145,600.00 - $270,400.00 Skills Desired Clinical Trials, Cross‑Functional Teams, Detail‑Oriented, Drug Development, Lifes sciences, Negotiation Skills, Problem Solving Skills, Regulatory Compliance, Risk Management #J-18808-Ljbffr