Global Regulatory CMC Lead /Associate Director - Biologics, Brussels

Reference: TM10502E1R

Expiry Date: 18-09-2020

Category Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
Belgium

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Job Description

Global Regulatory CMC Lead /Associate Director - Biologics, Brussels

We are recruiting for a Global Regulatory Affairs CMC Lead - Biologics for a global Biopharmaceutical company in Brussels. 

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.

This is a permanent role for an experienced Regulatory CMC professional to become a GRL CMC, Associate Director Grade. With an R&D driven Biopharmaceutical organization based in Brussels.

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 large molecules in assigned regions.

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 where English is the business language.

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.

We ask you to consider the following requirements:

  • 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 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 are now expanding their Regulatory Affairs CMC team across several geographical locations. This is a new role.
  • 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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