OPTION SUISSE ** Regulatory Director **Lead a NME in P3a/b to filings! High velocity filing role! Immuno & Inflammation (F)

Reference: JM10590F

Expiry Date: 02-08-2022

Categories Biotech, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
Oberbayern
Germany

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Job Description

This role is based in Switzerland and comes with a full relocation package, stock / bonus buyout and offers a high-end Swiss package!

My client is a well-known, household name, with many successes to their name, and a pipeline which is wide and diverse, and incl. mAbs, NCEs, Cell, and ADCs, across multiple therapy areas.

This role stands out though, as we are looking for a superstar filing person, who wants to work on a highly visible asset and lead it from readout to filing, as the senior EU regulatory liaison and strategist (you will have the support of EU RA Project Managers, and your own regulatory sub-team).

It’s a filing role, so you will be the bridge between the EMA, Co- / Rapporteurs and the development team, with the GRL being in the US and focusing mostly on international majors and of course, the US filings so you will need to be able to work with senior stakeholders and commercial teams, not just with the development team.

This role is not for someone who wants a 9.30 to 5 pm job, it is for someone who wants to lead the MAA and Clinical Line Extensions through to approval, and I can tell you, the molecule has great P2 data, a very good safety profile, and is a ground changing therapeutic, and so build your own career based on successful outcomes not activities.

The Project

You will lead a NME into first filing and subsequent filings for 4 line extensions new clinical indications; you will be accountable for EU Rapp / Co Rapp liaison, PTL liaison, SAs, pre Sub meetings, draft labelling (this is shared wit clinical and commercial) for labelling negotiations, and of course FUMs, the Day 120/180s etc. You will have more junior EU ADs helping you but you will be the master mind.

The Location

My client will relocate you and your family with a significant support package, a red carpet relocation, and the package includes car, pension, bonus and a big stock award. The quality of life in Switzerland is very high, people enjoy the environment, take their skiing very regularly and enjoy being in a country where driving 10 Kms does not take 45 minutes.

The Package

My client wants the best and is willing to pay the best, the roles come with a large performance related annual stock award, 20-25% bonus, high end salary and a car plus health insurance. My client will buyout any stock or bonus losses you would otherwise have from accepting their offer.

The Process

The Executive Director and VP is fast tracking this role, you will have an informal call with the line manager and then meet a small panel, before proceeding to any offer. Relocation support kicks off the day you sign a contract and is best described as all inclusive and red carpet.

 

To Apply!

To apply for this role, please contact me, Matt Greig or my colleagues Javier Monfort and Christian on Swiss number +41 41 562 01 51 or press the red “Apply for position” button, or send a full CV to CV@advtalent.com. We will support you throughout the interview and on-boarding experience.

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