Regulatory and Clinical Affairs Manager
| Posting date: | 12 March 2026 |
|---|---|
| Salary: | £55,690.00 to £62,682.00 per year |
| Additional salary information: | £55690.00 - £62682.00 a year |
| Hours: | Full time |
| Closing date: | 26 March 2026 |
| Location: | Huddersfield, HD3 3ET |
| Company: | NHS Jobs |
| Job type: | Permanent |
| Job reference: | C9372-26-0162 |
Summary
Determine and specify storage, labelling and product packaging requirements. The preparation of submissions of licence variations and renewals. Identify and liaise with external agencies, experts, key opinion leaders and contractors when required. The creation and submission of dossiers containing required information on Investigational Medicinal Products for submission in support of applications for Clinical Trials Authorisations. As required, write and contribute to the completion of investigator brochures, clinical study protocols, and clinical trial documentation for compliance with cGMP and other appropriate regulations and guidelines Informing the SMT and Board of the current status of regulatory compliance at HPS and establishing and implementing action plans to address any non-compliance. With support from the Managing Director, lead on all presentations to and communications with medicines regulatory authorities. With support from the Managing Director, Lead on negotiations with regulatory authorities. Undertake and manage regulatory inspections. Review of any commercial communications in relation to the manufacture or supply of medicines at HPS. Ensuring that HPS requirements for Pharmacovigilance are maintained. Liaison with external regulatory consultants in support of development projects including new product developments, Marketing Authorisations and investigational medicinal products. Project management of allocated commercial projects (e.g. clinical trials) and accordingly project manage teams of colleagues to ensure timely delivery of such projects. Ensure that HPS is kept up to date with national and international legislation, guidelines and customer practices. Contribute to new product development ideas and strategies and advise on regulatory requirements. Lead on the writing and the submission of tenders as required.