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CMC Regulatory Manager

  • LocationRaleigh, NC 27616 - United States
  • Work TypeFull Time - Permanent
  • Positions1 Position
  • Published At:a month ago


  • Job no: 37394
  • Categories: Regulatory Affairs

Job Description

Our client, a leading biopharmaceutical company, is currently seeking an accomplished CMC Regulatory Manager to join the team. Here is an overview of the role:

1) Provide guidance on ICH, FDA and EU CMC guidelines specifically on ATMP and keep up to date with the latest regulatory requirements

2) Manage the planning, scheduling and direct activities and programs through regulatory staff and project team members

3) Participate in short- and long-term planning of regulatory submissions related to drug products

4) Participate in writing and assembling CMC sections and technical files of regulatory submissions for drug products

5) Assist with preparing responses to inquiries from regulatory authorities related to site CMC activities with a focus on FDA submissions and European Health Authorities

6) Assist with regulatory assessment of changes to GMP documents and evaluation of Changes Controls

7) Support regulatory review of documentations which could be included in regulatory dossiers

8) Participate in preparing a book of specifications, QTA, contract and document review for subcontractors and suppliers for products manufactured at company

9) Maintain familiarity with company’s product ranges

Critical Requirements

1) A university degree is required. Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field

2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)

3) Recent experience in the biopharmaceutical industry is strongly preferred

4) Preference will be given to candidates with recent experience in regulatory management

This role is a great opportunity for the right person looking to advance their career with a wonderful company. If you are qualified and think that you are a strong fit for this role, please apply ASAP!

Compensation and Other Details

Base Salary: Highly competitive package, commensurate with experience


  • Published on 15 Apr 2021, 1:49 PM