Job Details

Job Summary:

OPTION SUISSE *** O N C O L O G Y *** Early and Late Stage Regulatory Development Project Manager * Relocation, great salaries, low tax! In the first instance, please contact Matt Greig or Theo Moore on +44 (0)207 801 3380 or out of hours you may call +44 (0)7918 679 405, alternatively, send a full CV today in confidence to matt@advregulatory.com

Requirements:

My client is a superb individual with a large department reporting in to her. She believes in empowering her staff and works through the Directors to ensure traction between development and the projects in hand (which are numerous and include both small and large molecules). In fact in the next 3 years this will be a very busy time for my client as they have several trials in Phase 3 reporting during this time and are seeking individuals to come in to provide the Global Regulatory Leader set piece for both US and EU submissions.

You will be a capable operator, with excellent personal communication skills, used to working in large global project teams, on regulatory development, filing and LCM. You will be the representative for all issues and plans, regulatory-wise, within the Global PLT and with the PL.

You will have managed at least one major first line filing through MAA CEP as well as several lifecycle filings such as indications / new dosing or other procedures; ideally you will also be experienced in US regulatory framework although a good understanding of this will be sufficient. Additionally you will have worked on Scientific Advice, EOP2, TPP or late phase filing negotiations, label defence, people mentoring and management (small or large teams my client has both), and of course lot’s of regulatory project management and planning.

In the first instance, please contact Matt Greig or Theo Moore on +44 (0)207 801 3380 or out of hours you may call +44 (0)7918 679 405, alternatively, send a full CV today in confidence to matt@advregulatory.com