Regulatory Affairs Associate - Slough, United Kingdom - WALKER COLE INTERNATIONAL LTD

WALKER COLE INTERNATIONAL LTD

Verified Company

Slough, United Kingdom

1 week ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Walker Cole International is searching for a Regulatory Affairs Associate to join a large pharmaceutical company based in Slough.

As a Regulatory Affairs Associate, you will be responsible for the on-going maintenance of the organisations prescription licensedmedicine portfolio and support new product development activities.

Your key responsibilities will include:

Support the Regulatory Team Leader, and wider Regulatory Team, is fully compliant with its responsibilities for licensed pharmaceutical products.
Contribute to the Regulatory strategy especially on Marketing Authorisation Applications (MAA's) and maintenance activities.
Support new MAA's as well as lifecycle maintenance of existing licensed pharmaceutical products, including the compilation and submission of documentation and dossier review.
Help ensure relevant departmental working practices and procedures are kept up to date and reflect legislative requirements and best practice.
BSc in life sciences or equivalent.
Worked in licensed medicines for at least 12 years (ideally).
Knowledge/understanding of CMC/CTD requirements.
Negotiating and influencing skills with key stakeholders.