OPTION BELGIQUE *** Senior Regulatory Manager ** Lead 2 indications to NDA! Relo Offered! (code 1810E5)

Reference: MG181019E5

Expiry Date: 19-12-2020

Category Regulatory Affairs

Salary: On Application

Job Type: Full Time


Apply for position

Job Description

OPTION BELGIQUE *** Senior Regulatory Manager ** Lead 2 indications to NDA! Relo Offered!

The Opportunity

Note: This role is based in Belgium and comes with a full relocation package!

You will be an existing Regulatory Manager or Regulatory Project Manager, and want to work on a NBE and take it through to Ph 3 design, readout, and final submission for a NBE which has great P2 data and multiple indications! You will work under an experienced Global Regulatory Leader who will mentor and coach you through the major regulatory milestones. This is what this role offers!

You will have worked in regulatory roles focusing on development, may be assisting a more experienced individual, or you will have supported NDAs or new clinical line extensions and now want more accountability for your own filings without overextending, as you will have both the Global Regulatory Leader and your Team Director, to support you.

You will want to work in a company where regulatory is a well-functioning machine, has a seat at the table for strategic discussions, and where regulatory works closely with OR/PRA, Clin Science, PhV, and the major project team members to deliver rapid submissions, for a molecule with adaptive or innovative development and filing pathways.


The Company

This is an R&D-based biologicals pharmaceutical company, with a great deal of experience and track record in their chosen therapeutic areas. The role is being hired by an individual with a strong track record in NDA/MAA filings and is regarded as a trustworthy and decent people manager. They have a strong pipeline with a number of late phase programmes, and are on the verge of major expansion, from new submissions, in the next 2 years.

The Package & Benefits

This role is based in Belgium and comes with full relocation, including disturbance allowances, temporary high quality apartment, as well as a tax reduction package (for non-Belgium nationals), as well as a performance bonus, decent annual salary, and full healthcare with EU coverage. There is also a extra-legal pension.

About You

  • Minimum experience of preparing Ph 3 CTAs (not CTA ops, more build, review, support for inputting into Clinical Protocol) combined with ODDs or having assisted on a New Indication Line Extension; preparation of Scientific Advice Meetings, or PIPs! 
  • PharmD or BSc/MSc or equivalent in life sciences; good communication and coordination skills
  • Ability to influence stakeholders by using regulatory intelligence and data driven communication in a friendly and useful way
  • A willingness to take part in coordinated multi-indication development programmes, by working with your colleagues who are managing the other indications!


To Apply!

To apply for this role, please press the red “Apply for position” button, or contact either myself, Theo, or my colleague Oli on +44 207 801 3388, or out of hours and weekends on +44 787 233 5879 and we will contact you by return.

We provide a high level of service because we believe this matters. Our people place individuals at the Specialist, Expert, Regional and Global Head levels, so if you want some advice on when or how to make your next step, or to understand what that next step might look like, let’s collaborate and explore these ideas with each other. ADV Talent Partners only advertise around 30% of our active roles, so for us to really help you, please Register or call us. We provide permanent and contract roles in the following areas, across the USA, Europe and Asia Pacific. General switchboard number +44 207 801 3380.

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.