Regulatory Affairs Operations Specialist

Sandoz • Princeton, NJ

1d • Hybrid

About The Position

The Regulatory Affairs Operations Specialist is responsible for supporting Sandoz’s regulatory operations with a strong focus on regulatory submissions and publishing activities, ensuring high‑quality, compliant, and timely submissions. This role requires solid experience working with regulatory systems, data management, and electronic submission tools, as well as a strong understanding of FDA guidelines and internal processes. This position supports registration data management, product life cycle activities, business process validation, and the preparation, review, compilation, and publishing of submission packages. The Specialist will also be responsible for tracking, indexing, and documenting regulatory information in a structured, efficient, and compliant manner. The role requires an independent contributor who is process‑oriented and capable of owning operational projects. The Specialist will liaise and collaborate with cross‑functional teams, contribute to process harmonization efforts, act as a system/process subject matter expert (SME), and provide operational guidance to ensure alignment with regulatory and business expectations. 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. Travel Requirements: Occasional travel, up to 5%. 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. Accessibility and reasonable accommodations 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 in order to perform the essential functions of a position, please send an email to [email protected] 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. Our Purpose here at Sandoz is pioneering access for patients. As the global leader in 'off-patent' high quality medicines, we are able to make medicine more affordable and accessible. Our broad global portfolio comprises of approximately 1,300 quality biosimilar and generic medicines, enabling us to provide more than 900 million patient treatments across 100+ countries per year, and while we are proud of this achievement, we have an ambition to do more! Powered by our talented and ambitious colleagues, who, in return for dedication and skills, experience a flexible, collaborative & inclusive culture where diversity of thought is welcomed and where personal growth is nurtured!

Requirements

• Education: Bachelor’s or associate degree in Information Management System, Information Management, Computer Science, Programming or Liberal studies, Advanced degree (masters) preferred.
• Work Experience: Minimum of 6 years in the pharmaceutical industry with 4 plus of those years in regulatory affairs operations.
• Regulatory submissions (publishing) background.
• System/data experience.
• MS Office Suite (Word, PowerPoint, Excel, Access, Outlook, MS Project), Adobe acrobat Pro, and Veeva vault.

Nice To Haves

• Project Management (A plus)
• GMP
• Problem solving
• Documentation and communication

Responsibilities

• Engages with cross-functional teams and independently manages deliverables with SME confirmation. Must effectively communicate without authority.
• Facilitates discussions to explore data challenges with the goal of driving sound decisions. Where appropriate, pushes for most favorable outcomes and solutions.
• Embraces digital and technological strategies to improve outcomes. Identifies opportunities, assess’ s for practicality, and builds sensible justifications. Including being a representative on business process validation and implementation.
• Demonstrates excellent communication skills; listens to audience and tailors messaging appropriately. Builds and leverages network to proactively address challenges and champion improvements.
• Facilitates, and when required, leads cross functional team meetings.
• Support harmonization process for efficiency
• Update and maintain procedures
• Supports drug product registration data and submission process through the accurate and timely completion of activities.
• Make and support decisions with independently clear actions
• Effectively prioritizes competing tasks in a fast-paced and dynamic environment.
• Develops and supports process for data governance creation and update
• Follows all procedures and proactively maintain all training I system/ information.
• Perform duties with the highest ethical standards, delivering only high-quality, compliant submissions to FDA.
• Accepts responsibility for results and outcomes and honors all commitments.
• Is a cooperative partner and works well with others for the benefit of the organization.
• Maintains a high degree of professionalism; builds trust with leadership and peers.
• Demonstrates ability to maintain focus and performance when faced with emergency situations; recovers from setbacks and demanding activities.
• Communicates confidently with superiors and peers; is transparent in all requests and responses.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree