Regulatory Affairs Compliance Sr. Specialist

Job Description Summary

Work closely and at the direction of the Associate Director Regulatory Affairs Compliance on all but not limited to the following:

Drive best practices and operational excellence within the department and cross-functionally by providing key regulatory intelligence updates via knowledge sharing and training to advance US regulatory expertise within Sandoz.

Ensure compliance with internal procedures as the RA point of contact for onboarding activities and global contact for training and reporting.

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

Major Accountabilities / Your Key Responsibilities:

Your responsibilities include but not limited to:

• Work with QA to author and maintain RA SOPs and Work Instructions
• Work with QA to maintain and update the curriculums and training for individuals in RA
• Work with the Associate Director of Compliance to manage onboarding for new employees in RA
• Assist the Associate Director of Compliance with user fee related activities CARES Act reporting FDARA reporting and FDA registration and listing activities.
• Prepare and submit License renewals
• Monitor regulatory changes and assess their impact on existing and future products advising stakeholders accordingly.
• Responsible for addressing requests for CoPPs FOIA information Samples and Apostille documentation
• Oversee the Annual Reports process and maintain the master schedule.
• Manages regulatory projects within the regulatory group and with other departments including creating and tracking deadlines and progressing projects

Key Capabilities Required:

• Knowledge of relevant laws and regulations
• Able to work independently and in a team environment
• Excellent communication and interpersonal skills
• Technical system skills (e.g. MS office applications databases efficient online research)

What youll bring to the role:

Required Qualifications:

Education:

• BS in a scientific field

Experience:

• 7 years of professional related experience including a minimum of 5 years of regulatory experience

Preferred Requirements:

• Generic experience

Youll 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$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 or call 1- and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

#Sandoz

EEO Statement:

Sandoz Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion gender national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status. We are committed to building diverse teams representative of the patients and communities we serve and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Accessibility and reasonable accommodations

Sandoz Group of Companies are 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 connect with us outling the job requisition number in your message.

Salary Range

$0.00 - $0.00

Skills Desired

Analytical Skill Clinical Trials Collaboration Detail-Oriented Lifesciences Project Planning Regulatory Compliance