Senior Associate, Regulatory Affairs

A leading American biopharmaceutical company is seeking a Senior Associate, Regulatory Affairs to join their team in Cambridge, UK on a contract basis.

Job Responsibilities:

• The Regulatory Professional under the direction of a Regional Regulatory Lead will lead compilation of CMC regulatory packages for submission and may be the lead for a program under supervision.
• Collect and/or create country-specific documents for regulatory filings worldwide.
• Compile and maintain CTA/MA documentation (e.g. variations, substantial amendments) in collaboration with Regional Regulatory Lead.
• Ensure compliance via timely submissions to regulatory agencies.
• Coordinate collection of functional documents in support of regulatory applications.
• As appropriate support execution of regulatory strategy.
• Support process improvement initiatives, standards development, and metrics.
• Assist in template development and maintenance.
• Train and supervise junior staff.

Skills and Experience:

• Strong communication skills - oral and written
• Ability to multi-task in a fast paced environment
• Understanding of drug development process
• Knowledge and understanding of CMC requirements, especially country-specific documents for international filings
• Familiarity with Document Management Systems.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Peter Duvall on +44 203 0789 542 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.