Senior Regulatory Associate -UK/Ireland
Location: Slough or Hull based 2 days per week
Salary: Up to 55,000 including a car allowance and 10% bonus
Reference number: JO-2205-493833
Were collaborating with a well-established global pharmaceutical business to hire a Senior Regulatory Associate. In this role, you will be responsible for managing/leading new product development activities for a large portfolio of OTC products in the UK/Ireland.
You will work on the front UK/Ireland regulations, undertaking activities required to ensure business needs are met as per defined priorities set by the regulatory management
New product development and compliance for UK Marketing Authorisations
Maintain existing licenses in designated regions and support new license applications.
Gap analysis of quality dossiers for licensing, including experience in reviewing and quality check of CMC documents for electronic submission to MHRA.
Participation in due diligence activities related to new products.
- Artwork review and approvals (PIL, primary and secondary packaging)
-Must have a relevant life sciences degree
-Must have a minimum of 4+ years regulatory affairs experience, ideally working on UK/Ireland markets
-Experience working with pre & post marketing activities is essential.
-Experience working with regulatory labelling activities (CCDS,SmPcs,PILs) is advantageous
-Must be based in the UK and eligible to work
If you would like to apply for this position or discuss our other active positions, please contact Charlie on 01189 522 797 or Charlie.Harris@cpl.com
- Agency: Cpl Life Sciences
- Reference: JO-2205-493833
Website: Cpl Life Sciences
- Posted: 7th June 2022
- Expires: 5th July 2022