Senior Manager Regulatory Affairs CMC, Regional Leader (code USA 11-19-1)

Reference: DG10487A

Expiry Date: 20-06-2020

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Durham County
United States

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Job Description

Senior Manager Regulatory Affairs CMC, Regional Leader

If you are thinking about taking on a leadership role as your next career step or you are looking for a better environment that will help you grow and provide international exposure, then you will most certainly find the vacancy for Regional CMC RA Leader a great opportunity.

About the company

My client is a world-renowned Biotech that has focused its efforts on developing medicines for patients with highly unmet medical needs. With a strong pipeline and number of award-winning drugs on the market, the company enjoys revenue of over USD 14B and has a highly promising R&D pipeline.

The company culture encourages close communication and collaboration between all teams and respects the holistic approach in overcoming challenges. The leadership team nurtures positive environment and progressively works towards providing work-life balance and flexibility for all employees.

About the role

In this position you will lead submissions for NBEs and provide input to the regional and global CMC Regulatory strategy. As a CMC Regional Regulatory Leader besides reviewing, authoring and compiling new BLAs and INDs for biological products, you will also become the primary point of contact for CMC RA topics and respond to questions from regulatory agencies.

About the requirements

  • At least 3 years of experience in the field of Regulatory CMC
  • Successful track record in authoring and delivering CMC submission content for biologics
  • Having experience authoring Module 3 for INDs and BLAs is essential
  • Experience in direct communication with Health Authorities.

Are you willing to find out more about this vacancy?

I look forward to introducing this CMC RRL in greater detail to you and to address any questions you would have. Please send through an updated version of your resume along with your contact details and let us arrange a brief phone call to elaborate on this great opportunity!


To Apply!

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

We provide a high level of service because we believe this matters. Our people place individuals at the Specialist, Expert, Regional and Global Head levels, so if you want some advice on when or how to make your next step, or to understand what that next step might look like, let’s collaborate and explore these ideas with each other. ADV Talent Partners only advertise around 30% of our active roles, so for us to really help you, please Register or call us. We provide permanent and contract roles in the following areas, across the USA, Europe and Asia Pacific. General switchboard number +44 (0)207 801 3380.

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