Senior Manager Regulatory Affairs CMC - mAbs, Berkshire, UK

Reference: OLI10571UK2

Expiry Date: 24-10-2021

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Windsor
Windsor and Maidenhead
United Kingdom

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Job Description

Senior Manager Regulatory Affairs CMC - mAbs, Berkshire

We are seeking a Regulatory Affairs Senior Manager CMC to join an international biopharmaceutical company and provide support and strategic leadership to teams and submissions in the EU, US and the ROW.

This is a permanent role based in the South East of England (M4 Corridor).

This role will be expected to give guidance and leadership to a range of projects in a range of regulatory requirements for biological products in development. This is an exciting role where you will get the opportunity to provide regulatory CMC leadership on cross functional teams, plan and define the regulatory CMC strategy for NBEs.

Who is our client?

Our client is a successful biopharmaceutical company with a strong pipeline of 20 plus molecules and a number of successful drugs on the market. This company has a proven track record of transforming patients’ lives through advanced therapies. This is a global organization and you will work in an international environment.

Key Responsibilities

  • Provide regulatory CMC leadership, advice on best practices and support to cross-functional teams.
  • Lead, plan, define and manage the implementation of the regulatory CMC strategy alongside the Global Regulatory CMC leadership team.
  • Coach and mentor staff members and manage direct reports as assigned.
  • Be accountable for the authoring and approval of Regulatory CMC sections of submission documents (IMPDs, INDs, MAAs, BLAs, NDAs, PiPs, Post-approval submissions etc.) for large molecules.
  • Responsible for all Health Authority CMC interactions, including answering questions and negotiation on CMC issues in order to achieve timely approval.
  • Lead cross-functional teams responsible for the Health Authority responses.

Key Requirements

  • Success in this role will require versatility and Regulatory Affairs CMC experience across the whole lifecycle. You will need minimum 5-7 years of relevant experience. Ideally, most of this will be in a Regulatory Affairs CMC biologics functions. Advantage will be having manufacturing experience or QA/QC or analytical development experience.
  • Proven track record of successful module 3 authoring and contribution to delivering a successful Marketing Authorization Applications for originator products in the EU or/and the US.
  • Experience working in a cross-functional environment, contributing to cross-functional teams and demonstrated competence in people management.
  • Experience participating in Health Authority meetings on Regulatory CMC matters.
  • Project Management experience, effective communication, ability to overcome obstacles to achieve timely results for products in assigned regions are all necessary skills and experiences.

In return

The package is very competitive and it comes with a bonus and other benefits. The job comes with a level of work flexibility post-Covid. The location is easily commutable by public transport, it is close to the main train stations and also includes parking for those willing to drive.

This role will give you the opportunity to become an integral part of a growing and successful organization, working next to experienced leaders who will help you get to the next level in your career. This organization invests in its people as well as its R&D. They are now expanding their Regulatory Affairs CMC team across several geographical locations. 

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact Oli Dimitrov on +44 (0)207 801 3388 or Theo Moore 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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