Manager, Regulatory Affairs Biosimilars

Company: Novartis Group Companies
Location: Princeton
Posted on: January 26, 2023

Job Description:

346763BR















Manager, Regulatory Affairs Biosimilars











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


















EEO Statement



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: https://talentnetwork.novartis.com/network

The pay range for this position at commencement of employment is expected to be between $118,400 and $177,600/year; however, while salary ranges are effective from 1/1/23 through 12/31/23, 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.

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 tas.nacomms@novartis.com 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.

https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings







Division



SANDOZ







Business Unit



COMMERCIAL OPS NA SZ







Country



USA







Work Location



Princeton, NJ







Company/Legal Entity



Sandoz Inc







Functional Area



Research & Development







Job Type



Full Time







Employment Type



Regular







Shift Work



No







Early Talent



Yes

Keywords: Novartis Group Companies, Trenton , Manager, Regulatory Affairs Biosimilars, Executive , Princeton, New Jersey