CMC Regulatory Affairs Manager / Senior Manager, Brussels

Reference: Oli10493A

Expiry Date: 02-01-2020

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Belgium

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Job Description

We have a role for an international Biopharmaceutical company based in Brussels, who are now substantially expanding their Global Regulatory CMC team.

This is a permanent role for a Manager / Senior Manager Regulatory Affairs CMC leading and supporting submissions for NCEs in the EU and the rest of the world.

Who is our client?

Our client is a highly-rated and successful company with a global reach. They are a drug discovery company investing heavily in R&D as well as their people. 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 and are committed to increasing access to high-quality healthcare products around the world.

The scope of the role:

The development team support all NCEs from Ph 1 to Ph 3, first MAA before handing it over to another team for lifecycle management. Both teams work together though, under one roof and it is possible for team members to work on a variety of projects where they can utilize their strengths in one area and also learn and develop new skills in another.

In this role you will:

  • Lead as assigned and manage the Regulatory CMC aspects of Clinical Trial Applications for small molecules
  • 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.
  • Manage CMC aspects of Health Authority questions and negotiations.

What are the requirements?

  • As a minimum you will have at least 4 - 5 years in the Pharmaceutical industry in a Regulatory Affairs CMC role. Don’t forget, we are recruiting for a Manager or a Snr Manager here, so we will accept applications with different lengths of experience and skill sets.
  • You will have experience writing CMC documentation for development products (IMPD, IND, PIP etc.).
  • You will have experience authoring high quality Module 2.3 and Module 3 of MAAs or NDAs as part of a larger team, also experience in lifecycle management, filing major variations, renewals, tech transfer etc.
  • Experience preparing responses to CMC questions from Health Authorities is needed.

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.
  • The role comes with a competitive salary, company bonus, car allowance and the usual benefits in Belgium. It is possible to work 1-2 days per week from home and the location is easily accessible by car and commutable by public transport from central Brussels.
  • Our client is willing to fund a relocation to a certain degree, including financial and logistical support to find a new place to live for those located outside Belgium.
  • Here you will work alongside experienced leaders who will help you learn, develop and get to the next level in your career.

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!

Who are we?

ADV Talent is a niche recruitment agency hiring for major bio/pharmaceutical companies and healthcare organizations mainly in the field of Regulatory Affairs and Regulatory CMC. We want individuals to be self-actualized for their own hiring process. This brings out the individuals to embrace change and identify with their next career move as an opportunity to grow. By this, our applicants grow, and so do our clients.

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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