Description
This is an exciting opportunity to join a highly respeced global pharma as a Clinical Trial Regulatory Leader.The successful candidate will
- Be responsible for managing regulatory aspects for assigned clinical trials spanning a number of therapeutic areas
- Be responsible for the overall trial submission strategy, and for the quality of regulatory submissions for CTAs, throughout the lifecycle of the trial
- Ensure that the required regulatory intelligence is in place to comply with country specific requirements
- Lead a team that will compile CTAs and associated CTA lifecycle submissions
- Liase with and manage CRO staff if CRO is used
Experience:
- Science degree or related experience within pharmaceutical industry
- Ideally 3-6 years experience within regulatory affairs in the pharmaceutical industry
- Strong understanding of Drug Development, Clinical Trial Authorization Applications, and general Regulatory Affairs
Desireable:
- Strong communication skills
- Strong project management skills
- Ability to lead complex projects
- Demonstrate problem solving skills
- High level of self awareness and adaptability
- Strong impact and influencing skills
If you are not currently looking but know of someone suitable that is, please do get in touch as we offer £200 in vouchers if your referral is successfully placed. Sthree UK is acting as an Employment Business in relation to this vacancy.