Associate Director Regulatory Affairs CMC - GRL role, Berkshire

Reference: TM10502F

Expiry Date: 29-12-2020

Category Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
Maidenhead
Windsor and Maidenhead
United Kingdom

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Job Description

Associate Director Regulatory Affairs CMC - GRL role, Berkshire

We are seeking a Regulatory Affairs CMC Lead (GRL) to join an international pharmaceutical company and provide support and strategic leadership to teams and submissions in the EU, US and the ROW.

This is a permanent role for an experienced Regulatory CMC professional to become a GRL CMC based in the South East, M4 Corridor. This role will be expected to give guidance and leadership to a range of projects in a range of regulatory requirements both for products in development and marketed products in the portfolio. 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 novel small molecules.

Who is our client?

Our client is a successful pharmaceutical 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 small 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 10 years of relevant industry experience. Ideally, most of this will be in a Regulatory Affairs CMC 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. The job comes with a level of work flexibility, where you can work 1-2 days per week from home. 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. This role is open to both candidates with small molecule experience and/or biologicals. 

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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