Regulatory Affairs Officer

Job Ref: J23130
Sector: Clinical
Sub-sector: Pharmaceuticals
Date Added: 08 August 2017
  • Harrow, Middlesex, England, UK
  • n/a
  • Neal Panting
  • 01753 589601

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The Role

To work on day to day life cycle management Regulatory Activities.

Key Responsibilities/Requirements:

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.

Skills/Experience Required:

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.