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Senior Specialist - RSPM - Temp

Employer
Regeneron Pharmaceuticals, Inc.
Location
Tarrytown, New York
Start date
Aug 25, 2021

View more

Discipline
Clinical, Clinical Medicine
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work

Job Details

Responsible for supporting document management of Clinical Trial Applications (CTA) and related health authority submissions through collaborations with internal and external key stakeholders: including Chemistry Manufacturing and Controls (CMC) team members and Contract Research Organizations (CROs), as well as corporate and collaborative partners, Regulatory Liaisons, vendor management and other cross-functional team members.

Responsible for supporting the tracking of Reference Safety Information (RSI) approvals by global health authorities. Additional responsibilities may include other documentation management needs for U.S. and other health authority submission activities.

Job Responsibilities

  • Responsible for tracking Clinical Trial Application (CTA) submission deliverables 
  • Manage CTA regulatory submission/document transfers between Regeneron and CROs. This can include scheduling meetings (Microsoft Teams) and applicable follow-up communication for deliverables.
  • Downloading of CTA deliverables from numerous CRO web-based systems and communicating updates to key stakeholders in a timely fashion. Uploading will also include numerous tracking platforms to help obtain metrics and communicate study updates to other teams. 
  • Collect, upload and manage Regulatory Agency communications, in all formats (e.g. emails, Phone conversations, hard copy letters, etc.) within the Veeva Vault RIM document repository. 
  • Brief review of regulatory packages and tracking of any issues or gaps in data collection.
  • Collaborates with the functional area team and key stakeholders
  • Communicates key RSPM related information to consumers, collects feedback, and takes action
  • Identifies and communicates regulatory system enhancement needs or technical issues

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
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States

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