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

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.   

  

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 

Salary Range

$145,600.00 - $270,400.00

Skills Desired

Clinical Trials, Cross-Functional Teams, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Problem Solving Skills, Regulatory Compliance, Risk Management