Regulatory Affairs, Specialist Labeling Position Available In Mercer, New Jersey

Regulatory Affairs, Specialist Labeling Sandoz Inc. parental leave, paid time off, sick time, 401(k), remote work United States, Jersey, Princeton 100 College Road West (Show on map) Jun 19, 2025 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! Responsible for supporting Sandoz’ business by preparing, reviewing, and submitting high-quality and compliant regulatory labeling submissions to the FDA based on Reference Listed Drug Labeling, FDA guidelines and regulations, and Sandoz internal policies and procedures.

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. Major Accountabilities /

Your Key Responsibilities:

Your responsibilities include, but not limited to: Maintain all assigned Sandoz approved, pending, and non-marketed products for life cycle management; this includes timely document creation, submission, drug listing, implementation, and archiving all labeling.
Completing all private label approval for implementation by negotiating and supporting individual requirements.
Creating labeling for global development projects (new ANDA) as well as marketed products based on Reference Listed Drug labeling by including research for FDA requirements, Sandoz requirements, current regulations, competitor labels, and site-specific requirements.
Support and maintain labeling for ANDA, NDA, BLA and IND.
Supporting and prioritizing launch labeling components readiness for a successful launch.
Applying strategic thinking, pharmaceutical educational knowledge, and regulatory intelligence for complex labeling creation, development, maintenance, and responding FDA deficiencies/queries.
Creating and Maintaining SPLs for products in alignment with changing technical requirements.
Providing recommendation and input for the work process which can help to improve the efficiency and clarification. What you’ll bring to the role:

Required Qualifications:

Education:

Bachelor’s degree in a scientific discipline

Experience:

Bachelor’s degree plus 6+ years in the pharmaceutical industry experience, with 5+ years in regulatory affairs labeling

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 $89,600 – 166,400 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. 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.

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. Join our

Sandoz Network:

If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: Sandoz Talentpool (novartis.com) #Sandoz