Senior Associate Regulatory Affairs
Oliver Care at CK Clinical is recruiting for a Senior Associate Regulatory Affairs to join a company in the pharmaceutical industry at their site based in Buckinghamshire on a permanent basis.
The main purpose of the role will be:
- To provide clear, timely, constructive regulatory advice and intelligence in the registration of new products and post-licensing activities in the UK/Ireland on local regulatory requirements.
- With support, plan, implement and lead regulatory activities in support of new product submissions and approvals, maintenance of marketed product licences and lifecycle management initiatives including the submission of variations and renewals and responses to agency questions as required.
- To Review and approve product-related packaging and other materials, as required and in accordance with company metrics/agency deadlines e.g. Braille, Patient Information Leaflet User Testing, etc.
Further responsibilities will include:
- Developing and maintaining personal contacts with key individuals within agencies and trade associations within the UK/Ireland, to ensure a clear understanding of agency requirements.
- Liaising with EU RA, the Packaging group and logistics to ensure that any labelling changes are planned and implemented in line with company and agency expectations.
- Supporting the UK regulatory function during internal audit and Agency Inspections for UK and IE.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Life sciences graduate, ideally with post-graduate qualification in a relevant area and/or prior experience in product development functions.
- Regulatory Affairs experience, including maintenance of pharmaceutical products within UK/Ireland and/or Europe.
This is an excellent opportunity to join a multi-speciality, global pharmaceutical company that delivers leading, innovative products.
For more information or to apply for this position, please contact Oliver Care on 01438 842976 or email email@example.com. Alternatively, please click on the link below to apply online.
CK Clinical is an Equal Opportunities employer who 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 CL33231 in all correspondence.