Regulatory and Clinical Affairs Manager | Calderdale and Huddersfield NHS Foundation Trust
| Posting date: | 12 March 2026 |
|---|---|
| Salary: | Not specified |
| Additional salary information: | £55,690 - £62,682 per annum, pro rata |
| Hours: | Full time |
| Closing date: | 11 April 2026 |
| Location: | Huddersfield, HD3 3ET |
| Company: | Calderdale & Huddersfield NHS Foundation Trust |
| Job type: | Permanent |
| Job reference: | 7829177/372-HPS1097 |
Summary
The post holder is responsible for compliance with the applicable medicines regulatory framework covering the operation of HPS and the medicines it manufactures. This includes regulatory compliance relating to Licenced Medicines, Specials and IMPs, Marketing Authorisations, WDA, Home Office Licensing and any additional legal frameworks which may impact on HPS activity.
The post holder will report into the Managing Director of HPS and will provides regulatory advice to HPS Senior Management Team (SMT) and HPS Board.
The post holder is responsible for the implementation of the Pharmacovigilance local service, and for liaison with the external Pharmacovigilance QP(s) to ensure that all required Pharmacovigilance systems are in place.
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· The creation of medicine registration dossiers containing required data for the submission and ongoing maintenance of Marketing Authorisations.
· From a regulatory perspective, manage a portfolio of products that HPS has identified as licensable candidates and develop regulatory, strategic and operational plans for obtaining their marketing authorisations.
· Maintaining and improving the Regulatory Affairs function within HPS; responsible for the assurance of regulatory compliance
· The development and maintenance of Standard Operating Procedures for the Regulatory Function.
· Ensure the maintenance of appropriate licensing, marketing and legal compliance of a range of pharmaceutical and medical products and ensure their safety and efficacy in the regions that HPS wish to market and distribute medicinal products.
CHFT is an integrated Trust of 6,500+ colleagues providing hospital and community services to patients and communities across Calderdale and Kirklees. We are rated as ‘Good’ by the Care Quality Commission, are a top performing Trust for Elective Recovery, Emergency and Cancer Care and widely acknowledged as a national digital lead when it comes to caring for people across our local and regional systems.
Our people are at the core of everything we do, hence our commitment to One Culture of Care. Our focus is to care for and support each other in order to provide outstanding compassionate care to our patients. That is why we are looking for an inclusive collaborative, creative, innovative and compassionate leader to join us in this role.
· 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.
This advert closes on Thursday 26 Mar 2026