Regulatory Senior Associate / Regulatory Manager ** NL but home based ** Manage EU CTAs and learn more about mid to late phase Regulatory strategy!

Reference: JPC600

Expiry Date: 30-09-2023

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time


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Job Description

  • Are you working with a CRO in regulatory but want to work for a biotech?
  • Do you want to work for a smaller and expanding biotech, with a market capitalization of 1.23 Billion USD, in a newly created role, where you will join a team of 5 which is set to grow and grow this year and next?
  • Do you know your CTA subs inside out for the EU and also can help triage with Ethics subs and CTA amendments?
  • Have you prepared, filed, and amended CTAs?
  • Have you helped to prepare annual updates, but now you want to learn over time how to do more ODD and full MAA submissions?
  • Are you happy to work at home but knowing your Head of Regulatory is based in the NL and will stay fully engaged with you?
  • Have you decent communication and customer facing skills with a can do attitude?

My client is a lovely decent person with a track record in filings gained with a bigger pharmaceutical company who has now taken over the reigns as the global head of regulatory, and is now building out their pipeline, which is close to entering pivotal studies. You will support Phase 1 2 3 trials, as well as CTA amendments, updates, ODDs, and eventually MAAs. My client wants you to establish the CTA subs systems and processes and be responsible for this in its entirety, so you will work directly with the GRLs (which is why we would like someone with an accommodating way of speaking but who can also manage expectations), as well as the CROs. The Head of is the line manager, and would work with you closely (and see you face to face regularly).

The company is on the up and up and has already made in the last 12 months two major licensing deals, bringing new molecules into their mid / late phase and early phase pipeline.

We really want someone who will take on this challenge with relish, and become the rock and foundation for the EU team. Next year new members will be hired, you will be one of the first.

To Apply!

Please contact me, Ivan Nash, at Ivan.Nash@AdvTalent / +44 207 801 3388 to discuss the role, if you are interested. I would be happy to support you with your application!

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