Global Technical Regulatory Leader (CMC GRL) (code USA 11-19-3)

Reference: DG10485B

Expiry Date: 12-11-2020

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Durham County
United States

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Job Description

Global Technical Regulatory Leader (CMC GRL)

If your forte is CMC RA and you are thinking about the next step in your career progression, you will definitely find this vacancy for Global CMC Regulatory Affairs Leader appealing.

An innovative biotech is looking for a passionate CMC RA professional to join their constantly growing team as a CMC GRL at one of their headquarters located in Research Triangle Park (RTP).

You will be provided with the freedom to plan and manage your assigned project in matrix structure by holding the ownership over the strategic and operational aspects of the project lifecycle.

In your role as a CMC GRL you will:

  • Compile and author global Regulatory CMC submissions
  • Lead on all interactions with Health Authorities in US and abroad
  • Be the CMC RRL of your assigned project for the region where you are located
  • Mentor colleagues and provide insight on the latest developments in the industry
  • Share your technical expertise and provide thought leadership to cross-functional sub teams

If you are an efficient communicator with a solid track record, and desire to spearhead innovative biologic products, then you will find the environment of the company very suitable to accomplish such achievements.

To successfully qualify for this vacancy you have should have:

  • Demonstrated ability to communicate with local and international Health Agencies and at least 6 years of experience in CMC RA
  • Successfully delivered CMC sections for MAA, CTA/IND, BLA
  • Managed and collaborated with remote teams worldwide
  • In-depth knowledge of international regulations and ICH/GMP requirements

Do you find the above appealing to explore further? Then please do not hesitate and send through a recent copy of your CV and I will get back to you shortly to share more!


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 RTP area.

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