Regional CMC Regulatory Leader Biologics at Senior Manager grade (code USA 12-19-2)

Reference: DG10500

Expiry Date: 20-12-2020

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Durham County
United States

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Job Description

Regional CMC Regulatory Leader Biologics at Senior Manager grade

I have a great opportunity for a Manager or Senior Specialist of RA CMC with bio experience to gain your first Senior RA Manager CMC role. Uniquely, this vacancy comes with a stock plan at this grade, but it is the role that will appeal, it is a pure development CMC RA role with one of the most respected biotech’s worldwide.

As a Senior Regulatory CMC Manager you will become the primary point of contact for your assigned product or projects and lead on the CMC aspects for your molecule all the way from early development phase to successful MAA/NDA submissions. Marketed products are looked after by another team.

What makes this vacancy different to the many other openings?

  • You will be able to see the impact of your efforts, because you will pick up the project from early development phase and lead forward all the way through successful approval;
  • You will be provided with the chance to acquire valuable exposure to the Global markets and expand your knowledge further by working on submissions outside of US;
  • You will enjoy being part of an organization with such diverse pipeline and the variety of modalities that you can explore, should you desire to become proficient in areas other than small molecule;
  • You will be fully supported in this challenging role by highly motivated experts, thus exchanging ideas and discussing innovative concepts will be part of your daily life;
  • Last but not least - you will definitely change the lives of great many patients with highly unmet medical needs all over the world.

What does it take to apply?

  • Strong technical foundation acquired with hands-on experience in pharmaceutical manufacturing, analytical development, quality assurance or related technical field;
  • At least 3-5 years’ (depending upon level of education) experience in Biological Regulatory CMC that includes authoring, compiling and reviewing IMPD/INDs, as well as authoring into Module 3 of NDA/BLAs / MAAs;
  • Successful track record in planning and managing projects;
  • To be a team player who can efficiently liaise with cross-functional teams and communicate with different stakeholders;
  • Always crave to learn more and to pioneer.

Certainly many of you have found the lines above appealing enough to explore this vacancy further and I look forward to receiving a recent version of your CV, or alternatively you can give me a call on 855.505.1382 to find out more about this exciting opportunity!

To Apply!

To apply for this role, please press the red “Apply for position”, or contact me, Matt Greig, on 855.505.1382 to find out more about the role.

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