Overview
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Calderdale and Huddersfield NHS Foundation Trust (CHFT) are committed to equal opportunities and welcome applications from all sections of the community, regardless of any protected characteristics.
We are committed to recruiting to our values. Leading One Culture of Care underpins our values by creating an environment, tone and behaviours across all parts of the Trust that are fundamentally rooted in compassionate care.
We are open to considering a wide range of flexible working arrangements. There are opportunities to flex the days of the week, hours and times of work and place of work including: part-time, job-share, flexible working hours and the possibility to work from home when appropriate. Please talk to us during the interview process to discuss any flexibility that you may require.
We received our Silver Award from the Defence Employer Recognition Scheme which is helping actively promote SaBRE - Supporting Britain\'s Reservists and Employers. This means that we provided its statement of intent to support all Defence personnel and we welcome application to work for us.
Our Future Plans
The Department of Health and Social Care has awarded capital funding to invest in local health services at both Calderdale Royal Hospital and Huddersfield Royal Infirmary. This is a significant investment and an opportunity to enhance services for our populations in Calderdale and Huddersfield and West Yorkshire for generations to come. To find out more, please visit https://future.cht.nhs.uk/
Job overview
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.
Main duties of the job
* 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.
Working for our organisation
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.
Detailed job description and main responsibilities
* 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.
Person specification
QUALIFICATIONS / TRAINING
Essential criteria
* Appropriate science degree and post graduate qualification in Pharmaceutical Regulatory Affairs
* Specific Regulatory Affairs training
Desirable criteria
* Qualification in project management e.g. PRINCE 2
KNOWLEDGE, EXPERIENCE & EXPERTISE
Essential criteria
* Significant experience of working in regulatory affairs within a pharmaceutical company
* Significant regulatory affairs experience and expertise in writing dossiers (eCTD), submitting and obtaining marketing authorisations / licences for medicines
* Project Management and the ability to manage and oversee multiple regulatory projects simultaneously
* Management and mentoring staff
* Pharmacovigilance
Desirable criteria
* Clinical Trials
COMMUNICATION AND RELATIONSHIPS (INCLUDING MANAGEMENT RESPONSIBILITIES)
Essential criteria
* Excellent communication in various forms (oral, written, digital) and maintain the ability to work as part of a team
* Ability to prioritise workload and meet deadlines whilst paying attention to detail.
* Demonstrate commitment to CPD Education and Training skills.
* Ability to work alone or as a team
* Ability to work under pressure.
* Ability to self-motivate and meet service deadlines.
Our vision is to provide One Culture of Care for one another in order that we can provide compassionate care for the people who use our services. We are passionate about creating a workplace where we work together to get results, encouraging colleagues to have their say, in order to co create the change we want to see. We take pride in the diversity of our workforce that's why we encourage applications from all. Reasonable adjustments will be made for disabled applicants.
We understand that more applicants are using AI technology to help with their applications. While these tools can be useful, they cannot fully capture your skills, knowledge, and experience. It\'s important that you personalise your application. Relying solely on AI is not recommended, as it may reduce your chances of success. Our screening process is thorough, so if you have used AI, please make sure to disclose this on your application form.
Please ensure your application is submitted with referees who can verify your employment/education history over the last three years and include valid email addresses for them. We will request electronic Factual Employment References from your previous employers. These references will be requested before you are issued with an unconditional offer of employment letter.
Candidates who require a Skilled Worker visa to work in the United Kingdom can determine the likelihood of obtaining a Certificate of Sponsorship for this position by assessing their circumstances against the criteria specified on the Check if you need a UK visa - GOV.UK website. We encourage all applicants to review these criteria carefully to understand their eligibility for sponsorship.
If you are appointed to a post, information will also be transferred into the NHS Electronic Staff Records system. The Inter-Authority Transfer (IAT) process is a critical and beneficial component of ESR and following interview your previous NHS employment data, if applicable will be transferred from your current / most recent employer.
You may be required to undertake a DBS. The Trust will administer the DBS check on your behalf and will recover the cost (Enhanced £54.40, Standard £26.40 or Basic £26.40) from your salary when you commence in post (including Internal staff). You will also be required to participate in the DBS Update Service and pay the £16 cost per year. This is a condition of your employment.
CHFT is part of the West Yorkshire Association of Acute Trusts (WYAAT), a collaborative of the NHS hospital trusts from across West Yorkshire and Harrogate working together to provide the best possible care for our patients.
If you have any questions please contact ask.recruitment@cht.nhs.uk for assistance.
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Documents to download
* JDPS (PDF, 544.3KB)
* Job Description Appendix A (PDF, 259.2KB)
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