REGULATORY CMC ASSOCIATE DIRECTOR / DIRECTOR ** HERTS / CAMBS

Employer
Advanced Regulatory (UK & Europe)
Location
Cambridgeshire (GB)
Salary
On Application
Closing date
14 Oct 2020

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Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
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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.

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.

GDPR & Data Protection: Your information is safeguarded for GDPR, and you will have the right to edit, amend or delete and ’’be forgotten’’ at any time after your initial registration.

About Advanced Search & Our Network

Advanced Search, has a network of affiliated companies including ADV Regulatory, and ADV Talent Partners. Together, we are specialists in Regulatory Affairs and Life Sciences recruitment especially around mAbs and biologicals for roles in R&D and Commercialization and have been established and hiring in this area since 2005.

Our Regulatory Affairs team know their subject matter areas and our mission is to help you grow your career each and every step of the way. We have helped many of today's leading companies develop strong regulatory sciences functions and are known for hiring complimentary teams that work well with each other, at owner-contributor, strategy leading and people management levels.

Contact us today to see how we can help you make that next career move on

+44 (0)207 801 3380

All applications are kept in confidence and we invite applications from all members of the Academic, Research & Development based bio-pharmaceutical community.

 

Advanced Regulatory is a new recruitment organisation. Our consultants are industry known and highly experienced in Regulatory Affairs recruitment. We have assembled a team with competencies in databased contingency recruitment, Search & Selection as well as Creative & Campaign management. Our specialism is Regulatory Affairs. We know that successful submissions are underpinned not by one but many people, all working in cohesion. Whether you require a new career position or a new recruit at junior, mid or senior level, we would like to assist you. Our remit is to provide Regulatory Affairs professionals at all levels to pharmaceutical, regulatory consulting, biopharmaceutical and clinical research organisations.

Contact Us
  • Suite 8 Penhurst House
  • 352-356 Battersea Park Road
  • SW11 3BY
  • GB
  • +44 (0)20 7801 3380
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