Our client is a major manufacturer of pharmaceutical products and they are looking for an experienced Regulatory Affairs Officer to join their expanding team.
To collate documents and prepare Marketing Authorisation Applications. To co-ordinate cross-functional teams to prepare responses to questions from authorities in a timely manner
A senior officer must be able to demonstrate the following abilities:
Planning and Organisation
Prioritise own project workload and meet deadlines.
Communication
Customer Service to Internal Staff and external sources
Liaison with development staff on NPI projects
Runs meetings for licence projects
Delivers training and presentations from courses. Trains junior staff
Inputs constructive ideas into decision making processes
Attention to detail and provision of documentation in line with guidance
Problem Solving - uses legal requirements and knowledge to troubleshoot and actively seek ways to prevent issues arising.
Prepares packaging (specials and licensed), reviewing against excipient guideline, pack check, Braille check and conversant with EU braille. Submission to external databases, liaison with user test team. Translations. Knowledge of blue box information. Provides guidance to 3rd parties. Final sign off.
Preparation of Type basic national variations. Preparation of Type II MR variations. Assessment of PSUR data. Review of junior staff variations.
Licence preparation - National, Decentralised Procedure, Mutual Recognition, US and 3rd parties. Liaises with 3rd parties. Audits licences
Clinical Trial Applications collation, submission and responses. Review of junior staff dossiers. Good knowledge of biostudies and review of reports.
To apply for this position, candidates must be eligible to live and work in the UK
Matchtech is acting as an Employment Business in relation to this vacancy.