Reference Number: JO-2208-498313
Regulatory Affairs Consultant
Rate: Negotiable
Job Type: Permanent
Location: Sandwich

Regulatory Affairs Contractor

12 month contract

Flexible working from Surrey or Kent

Offering up tp 33.00 Per Hour via PAYE

An opportunity has arisen with a internationally recognized pharmaceutical organization who are looking for a Regulatory Affairs Contractor on a 12 month contract basis. This opportunity is perfect if you are more recently starting your career within Regulatory and are looking to gain international experience. Working within the CMC team you will be responsible for the CMC site transfer and site related change submissions.

Job Responsibilities include;

Manage CMC post approval manufacturing site transfer submissions

Communicate changes to regulatory requirements and update the appropriate system in a timely manner

Support planning and monitoring activities, update timelines when necessary and communicate changes to the relevant partners Author local submission components as needed

Ensure submission packages are reviewed against local CMC requirements for consistency and completeness

Candidate Requirements include;

Eligibility to live and work in the United Kingdom

Bachelors degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences

Experience in regulatory affairs or compliance preferably in human medicines

Demonstrated regulatory experience with a pharmaceutical company with proven examples of contribution.

Proven ability to manage Regulatory issues and consistently deliver to time, cost and quality standards.

Regulatory experience including knowledge of Europe submission product lifecycle management processes.

If this opportunity is of interest to you please forward your CV to sophie.malyon@cpl.com.