Regulatory CMC Associate Director / Director ** Herts / Cambs

Reference: TM140820AD

Expiry Date: 13-12-2020

Category Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
Cambridge
Cambridgeshire
United Kingdom

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Job Description

My client is a well-known Global VP and now works for a smaller company, which is developing novel NMEs for their pipeline and has a late stage product being prepared for filing and launch. You will like this role for several reasons, it’s a smaller company, so the team will be close-knit, and you will be part of a regulatory leadership group which hires, recruits and develops their staff.

As well, the company have a pipeline which includes both early and late programs, so there is variety in this role, and you will work with CMOs /Contract Labs, technical management, and your counterpart in therapy regulatory, to prepare the CMC RA strategy, the M2.x /M3, as well as be responsible for CMC questions on Scientific Advice meetings and Pre- / Post-Submission Queries.

What I really like about the line manager is, they will enable you to work from home, and come into the office after Covid, when necessary, rather than expect your attendance, because they are interested in exploring the remote model with this role. Additionally, you will benefit from being in a team which is new, has to develop the systems and processes, the people they hire, so there is ample opportunity for growth in this company, both in role, and in terms of your role broadening over time.

During Covid, the company will hire you and on-board you digitally, with safe meetings face to face if possible.

The culture is fresh, and even though they are managed from a North American location, there are no silly time zones to worry about. The company are lean, agile and directional in their approach, so you will see governance is not something that takes months and months, they can act on data quickly and want an individual who can influence global decisions, while being accountable for EU strategy directly.

To be applicable for this role, it is likely you will have:-

  • Prepared / reviewed M3 CMC submissions for NMEs (first MAA) or substantial Variations / Line Extensions New Dosage Forms, in the EU region
  • Managed or supervised regulatory associates or senior associates or managers at some point, even if in matrix
  • Prepared RA CMC strategy documents, ideally, but not absolutely, for IMPs – preparation of IMPDs would be useful but not mandatory
  • Managed multiple response of Health Authority Questions for the EU area or extended EU
  • Managed with technical or contract labs issues relating to stability, CMC data packages, providing guidances on acceptability and other topics related to Pharmaceutical Development
  • Have examples of being a good team player, working with senior stakeholders, and translating challenges into solutions
  • Have a wider interest in developing the regulatory platform, systems and processes, as part of a team, or to support regulatory as a whole.

In return, this role comes with a package which would be attractive to anyone looking for a substantial Associate Director or Director level role (we have bandwidth), and the role comes with a high end salary, bonus, LTI plan. The company will buyout losses from leaving relating to bonus for 2020 for the right candidate!

 

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact Theo Moore on +44 (0)207 801 3384 or Oli Dimitrov on +44 (0)207 801 3384 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.

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