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Senior Manager, Regulatory Affairs - Rest of World

Employer
Regeneron Pharmaceuticals, Inc.
Location
Tarrytown, New York
Start date
Dec 3, 2023

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Discipline
Regulatory, Regulatory Affairs
Required Education
Doctorate/PHD/MD
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work

Job Details

As part of our global expansion, we are now looking to fill a meaningful role in our regulatory affairs function. This newly created role in International Regulatory Affairs offers an exciting opportunity to demonstrate your knowledge of local regulations and experience in leading regulatory strategy for our products in Rest of the World (ROW) markets, with a focus on oncology. In this outstanding position you will get along with a wide and diverse range of colleagues across the organization, both within market, within region and internally within Regeneron.

In this role, a typical day might include the following

  • Serve as a Rest of the World (ROW) liaison between the Regeneron central organization including but not limited to Global Regulatory Sub-teams, Global Clinical Sub-teams, labelling teams and local entities including partners.
  • Proactively develop ROW regulatory strategies for assigned programs in collaboration with Global Regulatory Lead (GRL) and Regeneron's Regulatory senior management and communicate evolving regulatory strategy insights within Local and Global organizations to maximize the potential of assigned assets in Local regions.
  • With oversight from GRL, lead marketing authorization application submissions in the ROW countries, including development of strategies and preparation of responses to Health Authority inquiries, support interactions with local Health Authorities to clear CTAs.
  • Work with regional leads and external partners to maintain licenses for approved Regenerons marketed products and ensure post-marketing commitments are fulfilled in a timeline manner.
This role might be for you if:
  • Knowledge of regulatory requirements and ability to problem-solve local procedures.
  • Ability to broker both CMC (biologics) as well as clinical aspects of local requirements will be a major advantage.
  • Excellent communication and organizational skills are essential.
  • Experience of leading regulatory activities for approved products with local

To be considered, we expect our Liaisons to have a PharmD, PhD or MD degree along with at least 5 years industry experience in biopharma regulatory affairs. We also require you to be in the Tarrytown, NY office a couple days a week.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$141,800.00 - $231,400.00

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Company info
Website
Telephone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States

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