OPTION BELGIQUE *** Regulatory CMC Sr Manager OR Associate Director mAbs & Biologics

Reference: CA030622

Expiry Date: 04-10-2022

Categories Biotech, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
Belgium

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Job Description

Our Client:

Our client is a medium-sized global pharmaceutical company, based on the Brussels area with a good count of marketed products and one of the first to register a mAb in Europe, but now are supporting multiple mAbs and recombinants in Phase 1-3, for global development as well as preparing first BLA/MAAs or managing lifecycle for biologicals and hence they are looking for a CMC Senior Manager or Associate RA CMC Director.

This role is based in Brussels, Belgium and comes with a full relocation package open to EU Nationals in any member state, including a disturbance allowance, tax reduction package, temporary apartment, and support for tax and accounting. We have as an agency moved over 60 Regulatory people to this company, and it is a fair and supportive package.

Position Responsibilities:

  • You will be the EU or EU / Intl or Global Lead for CMC RA projects covering global submissions for all phases of the product lifecycle (phase 1-3, MAA/BLA/NDA submission and post approval) for new biological entities, depending on your experience.
  • You will be responsible for defining strategy, planning and preparation of regional specific CMC submission documentation for assigned geographical regions and contributing to the preparation of global submission documentation to deliver timely approvals to meet business needs.
  • Responsible for authoring of the Module 3 components based on source document and Modules 2 for assigned products/projects, including new submissions and response to Questions from Health Authorities. Follows the process from creation, through review & approval and delivery of final documentation to the appropriate function.
  • Responsible for representing GRA-CMC & Devices on Global Regulatory Affairs Teams, Supply & Technical Solution teams, Global Development or Commercialisation Teams as delegated by GRA CMC Global Lead.
  • Responsible for leading and/or providing regulatory CMC input to all Health Authorities interactions and/or Notified Bodies on CMC matters in assigned region(s) as delegated by Lead and agreed with the GRA-CMC & Device Leadership Team and the PV-GRL.
  • Responsible for developing and implementing the CMC & Devices regulatory strategy and submission plans for assigned projects/products to deliver timely approvals to meet business needs in regions assigned, and in line with the global regulatory strategy.

For this role you’ll need the following education, experience and skills:

  • Bachelor’s Degree, Master’s preferred
  • Between 3.5-8 years in regulatory CMC including review, authoring and preparation of either IMPD or MAA M3 subs, or lifecycle management for Biologicals, which could be recombinants, mAbs or vaccines
  • Relevant experience in the pharmaceutical industry or a regulatory authority in a CMC review capacity
  • Preferably some professional experience in pharmaceutical manufacturing, analytical development, and quality assurance/control or related technical field
  • Proven track record of successful authoring and contribution to delivering CMC sections of marketing authorisations for new 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
  • Experience of direct communication and negotiation with regulatory agencies on CMC matters
  • Knowledge of GMP requirements and standard systems (e.g. change management systems and tools).

Package & Benefits:

The package they offer comprehends a very decent basic salary, with a 10-15% bonus levels before multipliers, and 38+10 days off a year, and stock plan for the higher grade!

Help for relocation is offered for the right candidate and includes a temporary apartment, a tax ruling program to decrease your taxes, disturbance allowance and support for tax preparation.

 

To Apply!

To apply for this role, please contact me, Javier Monfort or my colleague Christian on UK +44 207 801 3385 or press the red “Apply for position” button, or send a full CV to CV@advtalent.com. We will support you throughout the interview and on-boarding experience.

GDPR & Data Protection: Your information is safeguarded for GDPR, and you will have the right to edit, amend or delete and ’’be forgotten’’ at any time after your initial registration.