GRL / Global Regulatory CMC Lead - Small Molecules, based in Brussels

Reference: TM10502D1

Expiry Date: 04-05-2020

Category Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
Belgium

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Job Description

GRL / Global Regulatory CMC Lead - Small Molecules, based in Brussels

We are recruiting for a Global Regulatory Affairs CMC Lead for an international Pharmaceutical company in Brussels. 

This is a permanent opportunity for an experienced Regulatory Affairs CMC professional to become a Global Regulatory CMC Lead (Associate Director level) with a research driven Pharmaceutical organization based in Brussels, Belgium. You will provide regulatory CMC leadership on cross functional teams, define the regulatory CMC strategy, planning and preparation of submission documentation for assigned small molecule projects. Our client is a successful pharmaceutical company with a strong pipeline and a number of drugs on the market, transforming patient’s lives around the world. This is a global company and you will work in an international environment where English is the business language.

As a Global Regulatory CMC Lead you will:

  • 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 (ie. CTAs, MAAs, NDAs, PiPs, Post-approval submissions etc.).
  • 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.

The ideal candidate will have:

  • You should have at least 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 Small Molecule 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.
  • Experience defining regional CMC regulatory strategies.
  • 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 you will:

  • Get 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 have over 20 molecules in development and are expanding their Regulatory Affairs CMC team across several geographical locations.
  • Work in the global HQ where most of the Regulatory Affairs team is based.
  • The role comes with a competitive salary package including a bonus and various company benefits.
  • Working from home 1-2 days per week as well as having flexible work hours to avoid the traffic is possible with this organization.


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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