Expiry Date: 26-10-2021
Category Regulatory Affairs
Job Type: Full Time
Global Regulatory CMC Lead for ATMPs
We are hiring for a Regulatory CMC Associate Director to join a growing pharmaceutical company based in West Greater London (close to Welwyn Garden City and Hemel Hempstead).
This is a unique opportunity to join the new R&D unit of an already established, global Pharmaceutical company where you can become an integral part of a newly formed and agile team dedicated to gaining approvals for ATMPs targeting unmet medical needs.
Reporting directly into the Head of Regulatory Affairs and Cell Therapy you will be the Global Regulatory CMC Lead, not only for RA CMC strategy but also for health authority interactions/ Scientific Advice Procedures and the preparation of CMC sections of IMPDs and for MAAs.
The Global Regulatory CMC ATMP team is still in its early stages of development and your role will play a key hand in helping to build and develop a strong team able to technically support ATMP’s in both early and late stages development, and due to the size and structure of the department you will have many opportunities to showcase your ATMP CMC strategy and execution skills.
In this role, you will act as the Global Regulatory CMC Lead, working with Global Regulatory Project Teams and external partners to:
Who’s right for the job?
This is a rare and exciting opportunity to join the R&D function of a developing franchise in a high-profile role with full project responsibility for RA CMC ATMP products for the EU, Japan and ROW markets.
In return you will receive an excellent base salary, with a good bonus and a LTI plan, working for a global, R&D driven company dedicated to investing and developing its newly formed ATMPs team and pipeline.
To apply for this role, please press the red “Apply for position” button, or contact Theo Moore on +44 (0)207 801 3384 or Oli Dimitrov on +44 (0)207 801 3388 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.
Note: My client has committed to do digital hiring using Skype (VC), and has a new digital on-boarding and induction training process in place to allow a smooth transition during SARS-CoV-2 outbreak. During the next period, new hires will be allowed to work from home full-time, until such a time occurs when normal working returns.
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 (0)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.