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Princeton, New Jersey, United States
Hybrid
Not Available
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
Major Accountabilities / Your Key Responsibilities:
Key Performance Indicators:
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
Preferred Requirements:
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.
The pay range for this position at commencement of employment is expected to be between $145,600 - $279,400 USD/year; however, while salary ranges are effective from 1/1/26 through 12/31/26, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
On September 30, 2021, Sandoz entered into a 5-year Corporate Integrity Agreement. Certain positions will have responsibilities to support the execution and adherence to CIA obligations, CIA-related deliverables, and any relevant audit, monitoring or Independent Review Organization (IRO) remediation.
Sandoz - Notice at Collection to Employees Applicants 4.15.24[16].pdf
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!
#Sandoz
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 reasonable.accommodations@sandoz.com or call 1-609-422-4098 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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Salary Range
$145,600.00 - $270,400.00Skills Desired
Clinical Trials, Cross-Functional Teams, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Problem Solving Skills, Regulatory Compliance, Risk Management