Job 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.
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.
About us
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.
Job description
Job 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.
Job description
Job 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
- Appropriate science degree and post graduate qualification in Pharmaceutical Regulatory Affairs
- Specific Regulatory Affairs training
Desirable
- Qualification in project management e.g. PRINCE 2
KNOWLEDGE, EXPERIENCE & EXPERTISE
Essential
- 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
COMMUNICATION AND RELATIONSHIPS (INCLUDING MANAGEMENT RESPONSIBILITIES)
Essential
- 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.
Person Specification
QUALIFICATIONS / TRAINING
Essential
- Appropriate science degree and post graduate qualification in Pharmaceutical Regulatory Affairs
- Specific Regulatory Affairs training
Desirable
- Qualification in project management e.g. PRINCE 2
KNOWLEDGE, EXPERIENCE & EXPERTISE
Essential
- 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
COMMUNICATION AND RELATIONSHIPS (INCLUDING MANAGEMENT RESPONSIBILITIES)
Essential
- 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.
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
