Overview

Reference Number: JO-2012-459394
Senior Regulatory Affairs Manager
Rate: Negotiable
Job Type: Permanent
Location: Central London / West End

Role: Senior Regulatory Affairs Manager
Location: Central London
Salary: Competitive + benefits
employment: full time, permanent
Job reference:

Regulatory Professionals are collaborating with a midsize, clinical contract research organization. They provide services for Phase I-IV of drug and medical device development services including regulatory services and central laboratory services. Our client is seeking a full-time Senior Regulatory Affairs Manager or Associate Director to join their vibrant Regulatory Affairs team based in central London. This position will work on a team to accomplish tasks and projects that are instrumental to the companys success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.
.
Other duties will include:
Project management focus to facilitate full global regulatory submissions, which will include:
Advance and review of regulatory submission documents for Interaction with EMA, MHRA, and other regulatory agencies in support of clinical;
Maintaining full regulatory applications including Paediatric Investigation Plans (PIPs), Orphan Designations, PRIME and Market Authorisation Applications (MAAs)
Maintaining timelines for full regulatory submissions;
Providing regulatory advice and guidance to Sponsors and other departments to ensure compliance with the UK and European regulations and requirements;
Developing scientific and regulatory documents for EU agency meetings;
Reviewing pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges.

Knowledge & Skills
Right to work in the UK
Bachelors degree and demonstrated regulatory affairs experience;
Experience with EMA, MHRA, and other EU regulatory agencies is preferred;
Strong computer skills, project management skills, and high attention to detail;
Strong communication skills (both written and oral);
Must be a team player with a global regulatory mindset;
This position may require the supervision of junior level staff.

If you would like to apply for this position, please contact Amani via amani.yousef@cpl.com. If you are not currently looking but know someone who would be good for this role then get in touch. We offer a referral scheme at Regulatory Professionals where in which a successful recommendation will earn you 250 worth of vouchers *terms and conditions apply*