Regulatory Associate

Job Description

This position will be located at the Princeton, NJ U.S. Headquarters site.

Our Sandoz flexible hybrid working approach allows U.S. office-based employees to work up to 50% of their monthly workday remotely. This role will not have the ability to be located remotely. Preference will be given to local candidates not requiring relocation.

U.S. work visa sponsorship not available for this role. Must have U.S. work authorization.

• Prepare U.S. eCTD documents for submissions to support the biosimilar pipeline
• Coordinate U.S. regulatory activities with the publishing team and other global RA functions as needed (submission tracking, document templates, creation of U.S. FDA forms, cover letters, etc.)
• Manage high-quality regulatory documents and track regulatory activities in relevant IT systems to support team deliverables
• Provide support to regulatory teams on project-specific needs, as defined by each project.
• Coordinate key regulatory documents/information between various departments
• Maintain regulatory archives
• Support local regulatory requirements such as preparation of NDC forms, annual reports, etc.
• Execute and manage operational activities for assigned projects under the supervision of the regulatory teams

• Timely availability, accuracy and completeness of regulatory documents
• Active participation in relevant regulatory teams providing valuable operational input
• Adherence to Sandoz policies and SOPs
• Positive feedback from project team members, operational support teams, etc.
• Proactive working style demonstrating leadership and embracing Sandoz cultural principles

What you’ll bring to the role:

• Bachelor in a science‑related degree
• Experience (internships) in regulatory affairs preferred
• Fluent English required (oral and written)

• General understanding of drug development and regulatory affairs
• Proven expertise in organization and prioritization of tasks
• Strong interpersonal, communication and negotiation skills
• Ability to quickly familiarize with new IT tools
• Ability to work independently, under pressure, demonstrating initiative and flexibility
• Ability to operate effectively in an international and cross‑functional environment
• Strong organizational and planning skills

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 $70,000 – 130,000 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 may also include other elements, such as a sign‑on bonus, restricted stock units, and discretionary awards, in addition to full range of medical, financial, and other benefits (including 401(k) eligibility and various paid time off benefits). 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 and other discretionary payment or compensation programs at any time.

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.

Generic and biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader…