Senior Manager CMC RRL (code USA 11-19-2)

Reference: DG10487

Expiry Date: 30-06-2021

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Middlesex County
United States

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Job Description

Senior Manager CMC RRL

We at ADV Talent are delighted to introduce this exciting vacancy for a CMC Regulatory Affairs Senior Manager with one of the fastest-growing biotechs worldwide. With a cozy HQ in Cambridge and a dozen of highly successful drugs in their portfolio, this is definitely a company to explore in case you are considering your career development options.

What are the key responsibilities?

Stepping in the position of a Senior Manager CMC RA Lead for biological products in development you will lead the regional CMC strategy and:

  • Become the primary contact for CMC RA matters for your assigned program
  • Act as a Regional Regulatory Lead for your geographical location and your program
  • Lead on all operational aspects related to CMC RA for your assigned projects and assure proper planning, timelines optimization and successful submission to Health Authorities
  • Write and review CMC submission documents (BLA/IMPs) and respond to questions from Health Authorities.

What experience and qualifications are required?

The ideal candidate should have at least 3 years of experience in CMC RA and a solid track record in:

  • Authoring and compiling Regulatory CMC content for Module 3 for BLAs, INDs, IMPDs
  • Communication with regulatory agencies in the US and at least one of the ICH regions
  • Leading cross-functional and remote teams all the way through successful HA submission.

You should also be a confident speaker and an energetic manager that is willing to train, mentor and develop the team.

How is this job different to any other CMC position?

Among all the things you will notice yourself, as soon as you are invited to an interview, it is worth to mention that my client has been awarded for the way employees are being looked after. To utilize your expertise in the best possible way and bring meaningful impact to drug development, placing yourself in the right environment is a key to success. Besides, the friendly and highly professional atmosphere in the company this role comes with a great basic salary and benefits package, as well as a lucrative stock plan!

Did you find the above lines appealing?

If indeed, you are looking for your next career step-up, or you feel like it is time for a new challenge in the field of CMC RA, then do not hesitate and send me a recent version of your CV. I will gladly respond in return with a call to share more about this fantastic 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 Cambridge 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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