Regulatory Manager / Senior RA Manager ** Join EU MAA team, part of 1st MAA Bio then co-lead 5 new indications ** Novel MOA ** Relo Offered

Reference: TM2500A

Expiry Date: 07-12-2019

Categories Clinical Research, Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Belgium

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Job Description

 

Location - Brussels, Belgium

 

My client is a well-known biopharmaceutical company with a strong pipeline and a stable environment, seeking individuals who want to get ahead in their career, individuals who will apply themselves in order to grow and learn. You will consider this role if:

 

  • Want a pure regulatory development role, working on a NBE with V strong top line Ph2 data
  • Want to join a merit-based company with many examples of individuals who have achieved successive career development opportunities, and after promotions
  • Be coached by both a Team Leader and a GRL, in a company where both of these people have been promoted twice, this company really does develop their people!
  • Want to gain or consolidate your EU MAA filing experience, prep for pre-subs meetings, Day 120/180 responses, new indications filing, Paediatrics, for a molecule in Ph 3!

 

My client is seeking an individual who would be suitable for a Manager or Senior Manager role, who wants to be part of a highly rated regulatory organization led by some well-known figureheads in the drug development industry. At a team level, we placed the line manager here several years ago, and they have done well, through personal achievement, gaining 2 promotions so far, so us saying this is a company where you will be developed is more than just a catchall rhetorical comment, the company have 'good data'.

The company also have 'good (great) data' on their NBE, which you will benefit from working on, as they propel this molecule through to the final stages of a first MAA, with 5 line extensions / new indications in trial. You will support the MAA and then lead or co-lead one or more of the line extensions, some with broad labels, others with smaller patient populations with extremely chronic conditions; this drug has the potential to treat both.

 

We are seeking individuals who have either experience in preparing and filing line extensions / new indications, OR have worked on CTA builds for Phase 3s augmented by some regulatory lifecycle management experience as a minimum. We would also consider individuals who have assisted an EU regulatory leader on a set of submissions for the Senior Manager grade, and now would like to lead an indication themselves.

In return, my client offers a full relocation package from Europe, a progressive salary package (especially when compared to the UK, FR and southern European salaries), a tax reduction ruling, 38 plus 10 days off a year, bonus, and health insurance. My client will wait for notice periods!

 

To apply!

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We would welcome a phone call if you have any questions, or if you would like to find out more about the role, then please contact me Theo Moore on +442078013384 during the day, and for after-hours calls please contact me on my mobile number +44(0)7918.195.166.

 

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