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Manager, Regulatory Affairs Biosimilars

Princeton, New Jersey, United States
Closing date
Dec 20, 2022

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Other, Legal/Regulatory Affairs
Position Type
Full Time
Job Type
Organization Type
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Job Description

500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.

How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

An exciting opportunity to join Sandoz biosimilars; an important area of drug development bringing patients affordable medicines. Manage multiple products across different therapeutic areas. Be a contributor of regulatory strategies in drug development in all phases of development, including post-approval and life-cycle management. The individual will work closely with US regulatory affairs associates.

Your responsibilities include, but are not limited to:
Understands US regulations, guidance’s, and is aware of precedents: Provides input into global regulatory strategy of marketed products LCM, and identifies gaps or risks for FDA review
• Understands biosimilar, interchangeability and technical regulatory guidance’s
• Possibly serve as FDA liaison depending on experience
• Coordinates and implements regulatory readiness with other line functions

• Submissions:
- Responsible for coordinating US regulatory submissions, including IND, sBLA product line extension applications, change control and labeling supplements.
- Insure high quality submissions
- Help set up rapid response team to answer US information requests
- Contribute US labeling and artworks preparation

• Executes and manages operational activities for assigned projects

• Contributes to development of departmental goals and objectives

• Maintain compliance for assigned products (annual reports, DSURs, HA correspondence, monitor reference product label updates, adheres to SOPs

Diversity & Inclusion / EEO

The Novartis 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.

Minimum Requirements

What you'll bring to the role:
• Bachelor in a science required
• 1-5 years regulatory or relevant experience
• Experience in global matrix environment preferred
• Regulatory operational experience
• Ability to multi-task across various products, operational expertise
• Organizational awareness( interdepartmental relations, business priorities)

Why Sandoz?
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Sandoz!

Commitment to Diversity & Inclusion:

Novartis embraces diversity, equal opportunity and inclusion. 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.

Join our Novartis Network:

If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis
Network here:

Accessibility and reasonable accommodations:

The Novartis 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 send an e-mail to [email protected] call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Vaccine Policy:

While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to [email protected]
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