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Sr. Manager Regulatory Labeling

Employer
Regeneron Pharmaceuticals, Inc.
Location
Working from Home
Start date
Nov 29, 2022
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Job Details

The Sr. Manager of Regulatory Labeling manages the development, review, approval, and maintenance of the Company Core Data Sheets (CCDS), USPI, EU SmPC and Rest of World (RoW) labeling. Provides labeling expertise to the Labeling Working Group and other relevant stakeholders, typically carrying out responsibilities with minimal guidance. Leads development of labeling strategies and is responsible for the management of marketed or pipeline products, across the product lifecycle.

JOB DUTIES:  

  • Manages the Regulatory labeling process throughout the product lifecycle.

  • Leads the Labeling Working Group and manages development, review, approval, and maintenance of labeling for CCDS, USPI, EU SmPC, and RoW labeling. Manages complex programs with minimal support from the Labeling Director.

  • Leads development of labeling strategies through interpretation of labeling regulations, guidelines and competitor analyses, and application to product situation.

  • Leads the development of target labeling documents to support the design and analysis plan for clinical trials, with guidance from the Labeling Director.

  • Leads or contributes to discussions on labeling topics at relevant management interactions.

  • Effectively communicates labeling rationales to various levels of management to enable decision making.

  • Provides labeling expertise on complex issues to stakeholders. Anticipates Health Authority (HA) perspectives and broader implications of strategies, proposing alternatives and providing advice to mitigate risk. Communicates consequences to product portfolio.

  • Prepares submission-ready labeling documents. Maintains labeling documents in the electronic document management system and relevant labeling trackers as appropriate.

  • Contributes to the development of the Regulatory Labeling Group through active knowledge sharing andmentoring of junior staff members to build labeling expertise.

  • Monitors worldwide regulation changes pertaining to Labeling regulations and maintains the labeling SOP and work instructions. May be responsible for leading or contributing to various continuous improvement projects.

JOB REQUIREMENTS:

  • You have in-depth knowledge of worldwide regulations, guidance and review standards, and industry best practices and standards pertaining to labeling. Ability and competencies to rapidly establish therapeutic class working knowledge.
  • You have the capability to contribute to and lead a team
  • You are a strong communication with interpersonal skill to influence others in a positive and effective manner to build consensus
  • You can deliver results in a dynamic environment with a high level of professionalism and attention to detail or thoroughness.
  • You are able  manage staff and develop talent by mentoring them through increased levels of responsibility

To be considered for the opportunity, we expect you to have at 10 regulatory affairs, preferably within labelin. You have a scientific degree (i.e., Masters, PharmD, Ph.D) or at minimum, a Bachelor's degree (BS) from an accredited college or university in Life Sciences. We would appreciate if the individual has a PMP certificate

#GDRAJOBS #LI-Hyrbid

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)

$131,900.00 - $215,100.00

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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Find Us
Website
Mini-site
Regeneron Pharmaceuticals, Inc.
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
US
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