Regulatory Associate

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. 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.

Major Accountabilities / Your Key Responsibilities:

Your responsibilities include, but not limited to:

• Prepare US eCTD documents for submissions to support the biosimilar pipeline

• Coordination of US regulatory activities with the publishing team and other global RA functions as needed (such as submission tracking, document templates, creations of US FDA forms, cover letters, etc)

• Management of high-quality regulatory documents and tracking of regulatory activities in relevant IT systems to support team deliverables

• Provide support to regulatory teams on project specific needs, as defined by each project.

• Provide coordination of 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

Key Performance Indicators:

• 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.

• Pro-active working style demonstrating leadership and embraces the Sandoz cultural principles

What you'll bring to the role:

Required Qualifications:

Education & Experience (Required):

• Bachelor in a science related degree

• Experience (internships) in regulatory affairs preferred

• Fluent English required (oral and written)

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

Preferred Requirements:

• 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

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. Preference will be given to local candidates not requiring relocation.

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 $70,000 - 130,000 USD/year; however, while salary ranges are effective from 1/1/25 through 12/31/25, 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.

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.

Sandoz Reasonable Accommodations Statement:

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 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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