Director Or Vice President Regulatory Affairs - Biologics - North Carolina
MRINetwork (Raleigh/Durham-RTP, North Carolina)

Job id:  7548SMH

Director or Vice President Regulatory Affairs - Biologics - North Carolina

Location:  Durham, NC

Salary Range:  Commensurate to your experience

Come join our growing team and help take this company to the next level!  If you're an experienced, very hands-on regulatory leader who can assume leadership of our existing regulatory program, then read on...

We're seeking someone who can generate and execute our global regulatory strategy - primarily in North-America, but also in Europe and other areas.  You MUST have successful experience filing BLA’s.

Here's what the job entails:

·        Direct all regulatory affairs efforts.  Provide strong regulatory strategies leadership.

·        Emphasis placed upon meetings with FDA, CMC issues, clinical trial functions, and biological product development, submissions, and compliance.

·        Hands-on involved in generation and review of submissions.

·        Close direct communication with FDA and other agencies.

Our requirements:

·        Ph.D. or MS degree, preferably in life sciences.

·        10 years experience in Pharma/Biotech industry.

·        Direct experience with BIOLOGICS products.

·        Proven track record of successful preparation of INDs, NDAs, MFs, BLAs, and all amendments and supplements.

In return for your expertise and leadership, we can offer you the chance to work with good people in a dynamic, high-energy environment.  Moreover, you can work with the best immunotherapy platform there is, enjoying high visibility and a great network!  Don't hesitate:  send your resume to Scott Hobar for immediate review.

Talented employees: those that fit in, add to the culture and exceed expectations are nearly as rare as they are valuable. They have equal parts of drive, personality, boldness and tact. I look to find the right candidate for the right position. If you are an "Impact Player" in the pharmaceutical and biotech industry then we need to talk!

Submit your information to Scott Hobar for consideration.

Click here, ONLINE APPLICATION to apply for this job.

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