The Role: To provide RA leadership on product lifecycle management (change management) and global product registrations. Provide support for initiating and tracking impact assessments for...
To work on day to day life cycle management Regulatory Activities.
Co-ordaining and submitting the new applications and post approval changes.
To offer assistance in compilation of variation submissions to the agencies and to handle the validation phase and country specific requirements for the procedures with the aim of quick validation and procedure start.
To be a part of team and assist in documentation / archiving / communication to multiple departments the receipt of MA / variation details to ensure effective change implementation and compliance.
Support and assist the mock-up team in smooth implementation / change of updated mock-ups.
Close contact with Head quarter regulatory department to prioritize the new procedures and upcoming changes.
Should be ready to pick up any adhoc responsibility for the regulatory support.
Life Science Degree qualified
Considerable proven Regulatory experience with strong commercial awareness ideally in a Pharmaceutical/Manufacturing or a similar environment in a role maintaining post marketing maintenance.
Preparation of variations (Type 1A, Type 1B)
Preparation and submissions of notifications, PIQU applications, renewals etc.
Compiling submissions in NeeS/Ectd format
Accurate record keeping of correct artwork, applying version control etc
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589626
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.