Job Description

Regulatory Affairs CMC Manager, Biologics, Brussels, BE

We have a permanent role for a Regulatory Affairs CMC Manager based in Brussels, Belgium with a global biotechnology company.

• Work on Variety of projects from Phase 1 to Phase 3.
• Gain initial MAA/BLA experience and consolidate your EU and US experience.
• Work of fewer projects, but be more involved and take on responsibility early on.
• Do you enjoy writhing not just compiling? You will be authoring IMPD and Module 3 hear and although we will expect you to already have writing experience you will get a lot of support to improve, learn and grow in this R&D based company.
  
  

Our client:

Our client is a successful biotechnology company with a global reach. They develop innovative medicines for unmet medical needs and have an impressive pipeline of new molecules (NCEs and NBEs) coming up in development. They have some exciting new products coming in Phase II, Phase III and a number of products in early development. This company is committed to increasing access to high-quality healthcare products around the world.

The role:

This role will provide regulatory CMC expertise, leadership and oversite of projects in development in our client’s portfolio. You will have the opportunity here to work on a variety of indications, but also have the opportunity to follow through a molecule from Ph2/Ph3 to MAA/BLA in the EU and the US. You will have an input and support the implementation of regulatory CMC strategy as well as lead responses to the health authorities.

In this role you will:

• Lead as assigned and manage the Regulatory CMC aspects of Clinical Trial Applications for New Biological Entities.
• Provide regional strategic and operational Regulatory Affairs CMC expertise
• Write and review global and regional Regulatory CMC submission documents, IMPDs, INDs, new MAAs and NDAs etc.
• Lead and manage CMC aspects of Health Authority questions and negotiations.
  
  

What are the requirements?

• As a minimum you will have at least 2-3 years in the Pharmaceutical industry in a Regulatory Affairs CMC role.
• You will have experience writing CMC documentation (Module 3, IMPD, IND, PIP etc.) for development products or lifecycle management – biologic or biosimilar.
• You will have experience authoring high quality Module 2.3 and Module 3 of MAAs or NDAs as part of a larger team and also some experience in lifecycle management, filing major variations, renewals, tech transfer etc.
• Experience preparing responses to CMC questions from Health Authorities.
  
  

What is there for you?

In this company you will be given the opportunity to support or lead a project from early to late stage or submission right away. They like giving responsibility to Managers from the very beginning and promotions here don’t take long for the right person. Here you will work alongside experienced leaders who will help you learn, develop and get to the next level in your career.

The role comes with a competitive salary, company bonus, car allowance, a comprehensive health and benefits plan including a high company pension contribution. It is possible to work 1-2 days from home and the location is easily accessible by car and commutable by public transport.

How does this sound? Feel free to inquire more information even if you are not sure that this is the right moment for you to have a career change. We look forward to hearing from you.

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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