Regulatory Conformance Manager
Steve Lord is recruiting for a Regulatory Conformance Manager to join a small pharmaceutical company at their offices based close to Reading on a full time permanent basis
Our client is a small specialist firm that secures registration for niche medicines and medical device products and delivers them to market. This is a new position as the company is growing, there are opportunities to establish yourself within the business and team.
This position is based at the company offices to the west of Reading, with easy access both by rail and Motorway M4.
This position will work across business units support development, supply/distribution and post marketing regulatory compliance. Operating in a GDP and regulatory environment, you will be coordinating consultants, internal and external stakeholders to ensure compliance with required regulations.
- Managing and liaising with relevant service providers to ensure the company and products are in compliance with the relevant regulations, technical files, marketing authorisations.
- Development of regulatory plans/strategies and executing them for new products and changes to existing products (product life cycle management).
- Creating and reviewing SOPs to ensure compliance with MHRA and other authorities.
- Establishing and maintaining an accurate filing system for product and divisions.
- Supporting the GDP and PV areas of the business, as required.
- Maintain registration documents and electronic databases in line with company procedures.
- Degree educated, preferably life sciences or related subject.
- Strong pharmaceutical and/or medical device experience.- EU/US regulations experience.
- Able to work under pressure.
- Good attention to detail.
For more information or to apply for this position, please contact Steve Lord on 01246 457738 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 47326 in all correspondence.