This job has expired

You will need to login before you can apply for a job.

Manager, Regulatory Intelligence

Regeneron Pharmaceuticals, Inc.
Rensselaer, New York
Start date
Sep 8, 2023

View more

Regulatory, Regulatory Affairs
Required Education
Bachelors Degree
Position Type
Full time
Pharm Country, Best Places to Work

Job Details

The Manager, Regulatory Intelligence will be involved in supporting the gap analysis/readiness planning for critical regulatory initiatives such as the EU CTR (Clinical Trial Regulations), EU Pharma regulation, PUDFA etc, across different functions at Regeneron. We believe the Manager will be responsible for Regulatory Intelligence activities for global monitoring and surveillance of changes in the regulatory landscape focused on drug development lifecycle starting from preclinical through commercialization, as well as supporting GxP focused intelligence queries from various departments within the organization.

In this role, a typical day might include the following:

  • Supervise and analyze regulatory intelligence sources for the most recent changes and information in the drug development space
  • Assess regulatory intelligence information for relevance and impact to companys internal processes, drug development projects and/or regulatory strategies
  • Provide regulatory intelligence in support of a range of operational study design and operational planning activities. This includes regular updates on new GxP information including non-clinical, clinical and CMC, that could impact clinical trial execution.
  • Collaborate with cross-functional teams from preclinical to commercial to identify and assess key regulatory requirements, regulations, guidances, and information
    • Primarily, this role will focus on support of CMC requests
    • Support of requests from other Parent organization will be secondary

This role might be for you if:

  • You have prior experience in CMC, Quality, Companion Diagnostics
  • You bring a strong understanding of the drug development and commercialization process, with a focus on CMC, preferred experience with IVDR, EU MDR
  • You understand and interpret regulatory guidelines and documents
  • You are capable to research, analyze and extrapolate critical regulatory information with a focused on clinical requirements

To be considered, we look for 4+ years of life science experience with a focus in CMC Regulatory with a focus on IVD. We also expect candidates to be onsite a couple days a week as well.

#GDRAJobs #LI-Hybrid

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)

$108,200.00 - $176,600.00


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

FacebookTwitterInstagramYouTube Logo

Company info
Corporate Headquarters
777 Old Saw Mill River Road
New York
United States

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert