Expiry Date: 24-01-2023
Categories Biotech, Regulatory Affairs
Salary: On Application
Job Type: Full Time
About the client and the role:
My client is a top 10 R&D-based Biotech organization with a solid track record of successes and a diverse pipeline which includes NCEs, mAbs, CAR Ts and ADCs in multiple therapy areas, currently with 19 NMEs in Phases 1-3, and the franchise is significant in terms of turnover and investment into NMEs.
The line manager I am working with, for this role, is looking to hire an EU Liaison and Regulatory Strategy Director in Hematology to be the EU Liaison. She has a very good background and reputation in developing people and developed that bridge between global development and late development to filing in the European Union. You are accountable for regulatory input into EU late phase development for 3a and 3bs and managing the EU regulatory sub team, filing plan and pre- and post-submission EMA HA and Rapp / Co-Rapp negotiations and HA meetings.
You will be the overall EU strategy leader and mastermind behind your teams to translate the regulatory strategy into approvals and will be the EU contact person for all your assigned programs with the EMA and EU MS. This is a role for someone who wants to have visibility and accountability over all Hematology assigned programs in EU and manage their development and filing regulatory strategy.
The package includes a high-end salary, stock plan, car or car allowance, bonus with multipliers and health insurance for you; you can pay a contribution to upgrade it to your family, but this is also subsidized. Our client, for the right candidate, will buyout loss of stock or loss of 2022 bonus!
Also, a full relocation package is on offer if you are already living in Europe to be closer to their site; they are offering a hybrid working model where you will have to spend 50% of your time in their office to meet the teams and increase your visibility and impact in the organization.
To apply for this role, please contact me Javier Monfort on +44 207 801 3385 or my colleague Ivan Nash on +44 207 801 3388 press the red “Apply for position” button or send us an email to email@example.com and we will reply by return. We will support you throughout the interview and on-boarding experience.
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.