job details for:
Regulatory Affairs - Associate Director, Regulatory Affairs Jobs - Cambridge

Regulatory Affairs - Associate Director, Regulatory Affairs Jobs - Cambridge (Job Ref: WR/JOBS/25619-11992)

Job Description :

Regulatory Affairs - Associate Director, Regulatory Affairs Job - Cambridge

Cambridge:  Excellent Package

We are recruiting an Associate Director of Regulatory Affairs for our world class client, a global CRO providing discovery, development and post-approval services to pharmaceutical, biotechnology, medical device, academic and government organisations.  The Associate Director of Regulatory Affairs will be responsible for providing direct management and support to members of the Regulatory Affairs Strategic team in Cambridge. A key aspect of this role is that you will act as the “Executive” contact for the sponsor to oversee and ensure all aspects of Regulatory Affairs are conducted in accordance with their requirements

The Role

This role is based at their European head office in Cambridge with the successful applicant responsible for providing direct management and support to members of the Regulatory Affairs Strategic team.

They will also be responsible for all budgets and contracts in relation to their assigned projects.  This position directly relates to the development and securing of new business opportunities, and the day to day operational management of assigned regulatory services in accordance with contract, all applicable regulatory requirements and laws, and appropriate policies and procedures.

The Person

Candidates will be able to demonstrate good in-depth knowledge in either the preclinical, CMC or clinical environment and should possess the ability to motivate and integrate teams and teach/mentor team members.   They should have broad Regulatory Affairs experience, excellent knowledge of ICH and European/ROW Regulatory Procedures, including both clinical trials and product licensing and proven success in agency influencing and negotiation. Direct experience of successfully managing a team of Regulatory Professionals would be an advantage

Key Words

Associate Director of Regulatory Affairs, CRO, CMC, Clinical Research, Clinical Trials, Medical, Clinical, CRO, Study Management, Clinical Management, Pharmaceutical, Career, Research, Job, Recruitment, UK, Cambridge

For more information and to apply for this position, please contact Flame Health today on: 0800 085 0858