Associate Director, Regulatory Affairs - Biosimilars (US)

Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. This position is located at the Princeton, NJ US Headquarters site. Our flexible hybrid working approach allows US office-based employees to work up to 50% of their monthly workday remotely. This role requires on-site presence and is not eligible for full remote work. Candidates must be authorized to work in the U.S.; visa sponsorship is not available.

About the Role

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.

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.

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 health authority issues and participation in relevant regulatory boards leading to valuable input.
• Successful participation in health authority interactions to achieve business objectives.
• Adherence to Sandoz policy and guidelines, with positive project and stakeholder feedback.

Skills

• 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.

Requirements

• 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.
• Strong organizational skills with the ability to manage multiple priorities effectively.
• Experience in a global regulatory environment and collaboration with ex-US regulatory teams (preferred).

Benefits

• Competitive salary and generous company match for retirement savings accounts.
• Health insurance coverage for medical, prescription drugs, dental, and vision.
• Generous paid time off, including vacation, sick time, and parental leave.
• Hybrid work policy combining in-person and remote work for flexibility.
• Additional elements of the total compensation package may include a sign-on bonus, restricted stock units, and discretionary awards.

Pay

The pay range for this position at commencement of employment is expected to be between $145,600 - $279,400 USD/year. Final pay determinations will depend on factors including geographical location, experience level, knowledge, skills, and abilities.

About 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. We are investing in new development capabilities, production sites, acquisitions, and partnerships 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 talented and ambitious colleagues, who experience an agile and collegiate environment with impactful, flexible-hybrid careers. Diversity is welcomed, and personal growth is supported.