Regulatory Affairs CMC Manager, Biologics - Brussels, Belgium

Reference: Oli10481KR

Expiry Date: 26-12-2020

Category Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
Belgium

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Job Description

Regulatory Affairs CMC Manager, Biologics - Brussels, Belgium

We are recruiting for a Regulatory Affairs CMC Manager to work on biological products in development, with an established and successful biopharmaceutical company.

You will have both strategic and operational input for a variety of projects with this role, potentially from early phase through to MAA as part of the Global Regulatory Affairs CMC development team. You will work with an experienced GRL who will help you develop and get to the next level in an organization where individuals are judged on their own merits. In this role you will be working on a variety of projects. Based on your strengths and experience you would either be supporting a new MAA, BLA for a product in PIII or work on early development projects, supporting CTAs and authoring IMPDs, INDs, etc.

This will be a global, permanent role covering projects in the EU, US as well as the rest of the world.

Our client is an R&D driven Biopharmaceutical Company with some exciting new products coming in Ph 2 and Ph 3 as well as a busy early development pipeline. This is an established company that has already grown to become a major organization with very successful products. This company is now expanding their Regulatory CMC team globally and is seeking to hire a Regulatory Affairs CMC Manager in Brussels.

Who’s right for the job?

  • It is essential to have at least 5 years of Regulatory Affairs CMC experience with post and pre approval submissions. Successful authoring and contribution to Regulatory CMC sections, IMPDs, INDs as well as M3 section for small molecules or biologics.
  • Experience in direct communication with the Health Authorities on CMC matters.
  • You would also be a good communicator who is eager to learn and develop. You would have leadership and project management skills.
  • Fluent English is a must as this is the business language.

Benefits

This is a permanent opportunity and the salary is very competitive and includes a good bonus and an extensive company benefits package. There is also good flexibility to work 2 – 3 days a week from home. This role offers great projects to work on a real career development plan designed to give you all the experience you need to make the jump up to Regulatory Affairs Snr Manager and subsequently Associate Director CMC. You will get the chance to learn and develop here and be deeply involved with a project and follow it through. There is less separation and segmentation in this company and you won’t be stuck doing the same thing. You will be supported along the way. This organisation excels as a company because of its continual high standards, investing in its people as well as its science, and being able to foster a culture of innovation, collaboration and creativity.

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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