Regulatory Affairs CMC Manager / Snr Manager, work on NBEs (code BE)

Reference: Oli10481G

Expiry Date: 31-12-2020

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Belgium

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Job Description

Regulatory Affairs CMC Manager / Snr Manager, work on NBEs

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.

We have a permanent opportunity for a Snr Manager / Manager Regulatory Affairs CMC to join our client on their exciting journey.

Do you already have CTA / IMPD experience authoring and delivering Regulatory CMC submission documents and now want to do more first MAA / BLA submissions for novel products?

This Regulatory Affairs CMC role is based in Brussels, Belgium. Our client is an international Biopharmaceutical company with several block busters and a strong pipeline of exciting new biological products coming up in development. This organisation excels as a company because it invests in its people as well as its science, it has being able to foster a culture of innovation, collaboration, creativity and maintain continual high standards.

Responsibilities:

  • You will work in an international environment supporting a new MAA and subsequently moving on to supporting and leading biological molecules in development.
  • Lead projects as assigned and be responsible for the preparation, authoring and compilation of Regulatory CMC dossier for CTAs and MAAs (IMPDs, INDs, Module 3 for MAAs, BLAs etc.).
  • Be responsible for regional regulatory expertise and have an input into the development and implementation of global regulatory CMC strategy.
  • Manager the CMC aspects of regional Health Authority interactions.

Who's right for the job?

You will have 5 plus years relevant industry experience. Most of this would be in the Regulatory Affairs CMC field and you would have successfully authored and contributed to delivering CMC submission documents for biological products in development and marketed products. Direct communication experience with Health Authorities on CMC matters is required. Good level of English is a must as this is the business language in this organization.

In return you will:

  • This is an opportunity to become an integral part of an expanding Regulatory Affairs CMC team (these are new roles) in a successful company
  • Work in the Global HQ where most of the team is based and be supported by experienced Regulatory CMC leadership in a growing organization where the next career step will be open for
  • Earn a competitive for the industry salary, with a bonus and other company benefits. Have the flexibility to work from home 2 days per week.

Interested in the above? I 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 eb 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 or Theo 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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