Regulatory Affairs Senior Manager CMC, Early Dev. Clinical Lead (Gene Therapy), M4 Corridor

Reference: TM240120B

Expiry Date: 24-12-2020

Category Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
Maidenhead
Windsor and Maidenhead
United Kingdom

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Job Description

Regulatory Affairs Senior Manager CMC, Early Dev. Clinical Lead (Gene Therapy), M4 Corridor

This is a role for those who enjoy early development projects and have good experience in IND/IMPD/CTA regulatory submissions for biotech or small molecule products..!

Note: My client has committed to do digital hiring using Skype (VC), and has a new digital on-boarding and induction training process in place to allow a smooth transition during MERS-COV-2 outbreak. During the next period, new hires will be allowed to work from home full-time, until such a time occurs when normal working returns.

We have a rare, unique and interesting role for one of the world’s most successful, dynamic and innovative biotechnology companies. You will be working on early stage programmes (PI & PII) for a variety of different indications including biologics, small molecules and gene therapy projects across 2 major therapy areas.

This role is responsible for providing regulatory CMC expertise into the development and implementation of the regulatory strategies, operations and planning for the CMC aspects of assigned early development programs as the regional or global Regulatory CMC Clinical lead.

What’s great about this role is not only the variety of indications that you can work on (biologics, small molecules and gene therapy projects), but you will have the scope and option to take an indication forward through the development lifecycle to MAA/BLA as well as gain vital US project exposure, which will always enhance your career further down the line.

The position is graded senior manager grade and comes with an industry high basic salary, car allowance, yearly bonus (around 20%), lucrative yearly stock plan with a low vesting period and a comprehensive health and benefits plan including a high company pension contribution.

Duties and Responsibilities:

  • Provide EU and US strategic and operational regulatory CMC expertise and support in cross-functional teams, as required, and working flexibly within and across regions to provide broad operational support to ensure the delivery of project/products and business objectives.
  • Preparation and delivery of CMC regulatory plans for products in the assigned regions and supporting the preparation and delivery of regulatory submissions (IND/IMPD/CTAs)
  • Responsible for regional submission from defining and agreeing content with CMC global regulatory lead to leading reviews as required to ensure complete, concise and accurate submissions to Health Authorities in assigned regions.
  • Writing and / or Review of regional and global CMC submission documents and responses to Health Authority questions
  • Managing CMC aspects of routine and non-routine regional Health Authority interactions including issue resolution and negotiation of approvals, as delegated.
  • Monitoring changes in the regulatory CMC environment in assigned regions to support and advise CMC global lead and teams.

Qualifications:    

  • At least 5 years of experience in Regulatory CMC with knowledge of IND/IMPD/CTAs
  • Successful authoring and contribution to delivering CMC submission documents of development products (biological and/or chemical entities)
  • Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority in one of the ICH regions on development and post-approval products.

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 3388 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.

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