Global CMC Regulatory Lead Biologics (code USA 11-19-4)

Reference: DG10485A

Expiry Date: 12-11-2020

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Middlesex County
United States

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Job Description

Global CMC Regulatory Lead Biologics

Are you an experienced Technical Regulatory Affairs professional who is looking to conquer new horizons with an innovative biotech? Then you will certainly find the below lines interesting to read!

A well-renowned biotech is looking for a talented CMC leader to step in the role of a CMC GRL in one of their headquarters based in Massachusetts.

This is a strategic position related to the development and implementation of RA CMC strategy for biologics on regional and international level.

As a CMC GRL your key responsibilities will be:

  • Preparation, review and approval of global Regulatory CMC submissions
  • Leading on communication with Health Authorities worldwide
  • Providing technical and thought leadership to cross-functional teams in matrix structure
  • Coaching and raising awareness on latest changes and trends in the industry across the business
  • Acting as a Regional RA CMC Leader for the region where you are located.

With the above in mind, you will be provided with a fantastic opportunity to take ownership over a dedicated project and lead highly professional teams in matrixed environment all the way to international success.

If you are still wondering if this is a good fit for you, certainly the below key qualifications for the role will help you:

  • Broad experience in communicating with Health Authorities in more than 1 region and minimum of 6 years’ experience in Regulatory CMC
  • Successful track record of delivering CMC content for MAA, CTA/IND, BLA
  • Proven ability to plan and manage remote teams across the globe
  • Energetic and communicative personality, ready to mentor and help others raise their qualification.

If all the above has grabbed your attention and you are curious to learn more about this great opportunity, please send a recent version of your resume and your contact information and I will gladly discuss the details with you!

To Apply!

To apply for this role, please press the red “Apply for position”, or contact me, David, on 855.505.1382 to find out more about this role and other positions we have for other companies in the Cambridge area.

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