REMOTE or NC or MA: CMC Regulatory Manager or Sr CMC RA Manager (Small Molecules or Oligos) ** Work with a successful stable biotech **

Reference: NBUC518

Expiry Date: 15-11-2022

Categories Biotech, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
Wake County
Съединени щати
Remote Working

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Job Description

My team and I would like to introduce you this exciting opportunity to join our client organisation, which is a global pharmaceutical company, known for having solid systems and processes, very well-funded and where the environment is with low politics and well-established, where you can be more recognisable, have more visibility and be rewarded for your success.

The role is for a Manager or Senior Manager with strong Regulatory CMC and experience of preparing INDs / IMPDs and M3 for clinical phases or M3 builds for NDAs. You will be working on multiple projects, supporting Global, including US submissions.

Why would you consider this role?

  • You want to work on one of the most interesting development pipelines in Industry
  • You want to work in partnership for global programs, LCM activities and considerations for US
  • You want to work on mid and late phase and support more initial NDA/MAA’s
  • You will receive a great package
  • You would want to work fully remote with occasional FUNDED travels to site
  • You want to be part of the regional and global strategic and operational regulatory CMC expertise and support in cross-functional teams for the delivery of US & EU projects
  • You would like to prepare and deliver CMC regulatory operational plans for your assigned products in the respective regions and supporting the preparation and delivery of regulatory submissions (IND/IMPD/CTAs)
  • You want to be responsible for leading or assisting in delivery of Reg CMC initiatives and the development of Reg CMC standards and SOPs
  • You will work with MSAT team based in US, CMO's are EU (Swiss), Team CMC is Global, asset team in Cambridge 

Covid, Location and Package:

  • This role is fully remote, and if you travel to site it is funded; the company has sites in the East Coast, and you are eligible for hire, if you live anywhere in mountain, central or eastern standard time.
  • The company pays a high teen’s bonus, which is good for Manager or Senior Manager levels, there is an annual stock award, and a good company health package!
  • The company will consider compensating you for loss of bonus if you leave this year! The annual stock award is quick vesting.

 

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact me, Theo Moore or my collegue, Christian on US 908 348 6714, or send a full CV to CV@advtalent.com and we would be happy to discuss the role further and give you more information. As we know the hiring manager, we will support you throughout the interview and on-boarding experience.

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