OPTION SUISSE ** EU Regulatory Affairs Director ** High Value Assets in Clinical Phase ** With Relo **

Reference: JM200522

Expiry Date: 30-08-2022

Categories Biotech, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
Bern
Switzerland

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Job Description

My client is a well-known top 10 bio-/pharmaceutical company with more than a dozen high value marketed products, and a pipeline which is wide and diverse. This company has already registered Cell Therapies, so this is no slow coach of an organization, they invest >10 Billion USD per annum in R&D! 

** This role comes with a strong package, as well as full support for EU nationals to relocate to Switzerland **

This role is to work in one of their therapy areas (either Neurology, Cardio or Immunology) on mid to late phase development, MAA and New Indications filings.

As the EU RA Director, you are responsible for the EU late phase strategy, filing and HA liaison and negotiation you will have a RPM supporting you as well as a sub-team.  What I like about this prestigious organization is:-

  • Robust leadership, the Regulatory Leadership team is highly polished, very committed (they have all been in post for more than 10 years), supportive and empathetic and they engage with their staff
  • Well-funded, the company can act on new data and fund Ph 3Bs quickly, governance is clearly defined and quicker than most, the company tend to parallel file and develop in the Europe and China, this role is EU facing
  • Regulatory Directors are considered senior in the organization and are given opportunities to develop their people management and organizational skills, through team or functional initiatives, as well as promotion
  • There are no ‘me too’ drugs in their pipeline, all of the NMEs have novel MOAs, the NMEs are a mix of mAbs, ADCs, NCEs and Cell Therapies
  • Global give the EU a voice on the table, the EU RA Directors review clinical protocols and also lead the EU Scientific Advice, and Rapp / Co-Rapp meetings and are the POC with the Regulators.

In return for a generous package (see below), my client is seeking individuals who have filed MAAs or major line extensions, have a polished communication style, and are proactive. The company is large, but once you are in your program teams, it has a much smaller feel that the top 3 companies.

Package & Relocation

This role comes with an annual stock plan (RSU based), which is approx. 25% of basic salary, a bonus of 20% plus, Swiss car or car allowance, health insurance and paid vacation as well as an extra week for Christmas shutdown.

 

To Apply!

To apply for this role, please contact me Javier Monfort, or Christian Atanasov on Swiss number +41.41.562.0151 or alternatively, please send a full CV to cv@advtalent.com and one of us will contact you by return. We will support you throughout the interview and on-boarding experience.

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