OPTION BELGIQUE *** Sr / Regulatory Programme Manager *** EU and GRL Career Pathway *** No mature products! GAIN RA Dev and NEW Lifecycle

Reference: MGADV12345D

Expiry Date: 07-11-2019

Categories Biotech, Clinical Research, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
OV
Belgium

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Job Description

Location: Brussels, Belgium

 

This role will appeal to individuals who want to work in a Global HQ where 70% of ALL decisions are made in the same building! This role is based in Belgium, comes with an attractive salary, bonus, and a great deal of opportunity to grow. This company has a track record of developing individuals from Manager and Senior to the Global Regulatory Lead level!

This client is an expanding bio-pharmaceutical company with new products coming to market, and major new NMEs coming out of Ph 2B in to Ph 3, requiring new headcount, and an expansion of their regulatory development and new lifecycle teams (new indications / line extensions - CMC subs are looked after by GRA CMC).

These roles are at Senior Regulatory Manager level, and will appeal to the following individuals:-

  • Aspiring, hard-working, willing to get stuck in, you could be a looking for your next career role having developed in your current role, and now want a new challenge
  • Want to work in a European company with diverse multi-cultural feel and leadership team and English as a business language
  • You see yourself at Manager or Senior Manager level: you have already co-led your own projects for NMEs in Ph 2/3 or filed or co-filed MAAs or major Line Extensions
  • You will have authored Brochures for EMA SA / EOP2 and co-/led Scientific Advice meetings with the EMA or national HAs; you will have devised and developed regional regulatory strategy documents and plans; you may have started to take the liaison role with the EMA and nationa HAs
  • Offer a strong combination of the scientific background (MSc or PhD ideally, BSc also considered) coupled with regulatory and business understanding, able to translate clinical data and clinical science to develop narratives in to RA strategies and dossiers that regulators can understand  
  • Want progressive, step wise development and want to be a GRL in the future, without having to move to Switzerland or the USA; in return are willing to be flexible, work across multiple products / projects
  • Fundamentally you believe yourself to be a Strategic Thinker, wanting to develop in to the GRL role based on your merit and performance.

Although this is just a guide, you will have 4-7 years EU or international plus EU regulatory experience gained on NMEs or major new indication programmes. We have more than one role, so can accommodate more than one background type because this company wants diversity in their teams.

 

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, or my colleague Matt Greig, in the London office on +44 (0)20 7801 3384, or at any time during evenings on +44 (0)7918679405.

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.

 

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