Sr Regulatory Affairs Manager ** Do you want to be part of a major MAA filing? In a company with the GRL pathway available ** Mainland EU

Reference: MG10407B

Expiry Date: 20-10-2019

Category Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
Belgium

Apply for position

Job Description

 

Location: Brussels, Belgium

 

We are pleased to present you this role for a major bio-pharmaceutical company, where both the ideas of the GRL career pathway and working on a new MAA are part of this opportunity. You will be joining a successful company in a smaller team to focus on filing a MAA with multiple indications, a mAb, which is currently at the End of Phase 2 / Phase 3 where you will directly work with the GRL who is highly experienced and much liked.

So you will want to work in an organization where the GRL career pathway is open to you, but to get there you want to consolidate your experiences and build upon these by working on taking a NBE from Phase 3 into filing and review. So this will include preparing CTAs for submissions through CROs and the affiliates, preparing Scientific Advice / Pre Subs Meetings and Brochure packs for different indications and, for PIPs. After this, the team will work together to prepare the MAA (in a company where the CMC is done by another team).

The role can be graded Senior Manager / Manager and you will be part of a team where most of the GRLs and Team Managers started in a near identical roles, so they have managed to grow, and so will you, because the environment lends itself to sharing know-how and working collaboratively, where merit is rewarded.

You will have 2 of the following to be able to apply for this role:

  • Preparation of regulatory CTA submissions, Scientific Advice or PIPs
  • Preparation and / or filing of Line Extension New Indications
  • Early Phase regulatory work, whether for a CRO or PharmaCo
  • Regulatory coordination and management of Day queries or FUMs (follow up measures) even if you joined the project just post submission.

In return, my client will pay for a relocation including temporary housing and a settling-in allowance, plus a strong package including bonus, plus 48 days off a year and a top level health insurance package.

 

To Apply!

To apply for this role, please register on this web site. My team and I would welcome a phone call in private if you would like to explore this role and opportunity, then please contact either myself, Theo Moore on +44 (0)20 7801 3384 or my colleague Oli on +44 (0)20 7801 3388.

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.

We provide a high level of service because we believe this matters.

 

Keywords / Key words: Regulatory Affairs, RA, RA Jobs, Regulatory Affairs Jobs, RA Manager, Regulatory Jobs, Regulatory, Biopharmaceutical Jobs, Biopharma Roles, Biotechnology, Biopharma, Pharmaceutical, Pharma, Bio-pharmaceutical, Bio-technology, United Kingdom, Global Regulatory Affairs, Snr