Job summary
Huddersfield Pharmacy Specials (HPS) is a NHS hosted Specials manufacturing unit. Our mission is to provide high quality, affordable specials throughout the UK to both Primary and Secondary Care. At HPS we manufacture a wide range of products including dermatological, oral and topical liquids, infusion fluids and ampoules. We also provide a bespoke packaging and labeling service.
The facility has a MHRA Manufacturer (MIA) and "Specials" (MS) Licences, a Wholesale Distribution Authorisation (WDA(H)) and a Manufacturer Licence for Investigational Medicinal Products (Clinical Trials) (MIA(IMP)).
HPS is a semi-autonomous division reporting to the CHFT Board through its own Management Board.
The Head of R&D and Regulatory Affairs will be responsible for the running of the new product development and Regulatory Affairs functions within HPS. The post holder will be accountable for the development and submission of marketing authorisations and will manage an ongoing portfolio of licences and opportunities. The role will also involve management of clinical trial projects.
Main duties of the job
Main Tasks - Research & Development management
- Ownership of R&D and innovation strategy and delivers on annual plans and targets
- In conjunction with the Managing Director, develops strategies and plans for new products
- Development from lead candidate formulation to MAA submission; development project plans will cover all aspects of R&D and manufacturing of finished licenced (and specials) products and IMPs for use in clinical trials
Main Tasks - Regulatory Affairs Management
- 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
- From a regulatory perspective, manage a portfolio of products that HPS has identified as licensable candidates and develop strategic and operational plans for obtaining their marketing authorisations
- The creation of medicine registration dossiers containing required data for the submission and on-going maintenance of marketing authorisations
About us
We employ more than 6,500 staffwho deliver compassionate care from our two main hospitals,Calderdale Royal Hospital and Huddersfield Royal Infirmary as well as in community sites, healthcentres and in patients' homes. We also are incredibly proud to have almost 150 volunteers here at CHFT.
We provide a range of services including urgent and emergency care; medical; surgical; maternity; gynaecology; critical care; children's and young people's services; end of life care and outpatient and diagnostic imaging services.
We provide community health services, including sexual health services in Calderdale from Calderdale Royal and local health centres. These include Todmorden Health Centre and Broad Street Plaza.
We continue to modernise and invest in our health services to build on our strong reputation.Foundation trusts are public leaders in improving quality in health services. They are part of the NHS- yet decisions about what they do and how they do it are driven by independent boards. Boardslisten to their Council of Governors and respond to the needs of their members - patients, staff andthe local community.
Foundation trusts provide what the health service wants, yet are also free to invest quickly in thechanges to the local community needs, in striving to be the best, and in putting their patients first.
Job description
Job responsibilities
- Responsible for the strategic, effective and efficient use of external partners for the sourcing and development of APIs and other starting materials and associated formulation testing and analytical development services
- Prepare and manage budgets
- Write and complete relevant dossier sections for regulatory submission that cover (for example) product development, analysis and manufacturing processes
- Review proposed changes to regulated processes and /or products to identify regulatory implications in both pre-approval and post approval regimes
- Liaise (in conjunction with the Managing Director and quality personnel) with the MHRA, and other regulatory agencies for all formulation and development related topics for both pre- and post-approval
- Applicable to research and development, work closely with company senior management to provide strategic and operational planning for all aspects of sourcing and receipting of materials (supply chain management) from early development to commercialisation
- Interact with key scientific, clinical research, marketing and commercial personnel within and outside the company to ensure timely and accurate regulatory compliance on formulation matters
- Direct point of contact for external contractors/suppliers and internal staff
- Develops an understanding of market conditions and competitor developments
- Provides client and competitor information and intelligence to senior management
- Assists with the compilation of the annual business plan for HPS in conjunction with the senior management team and the finance department
- Assists in preparing and presenting business cases as necessary to secure the necessary funding for service development
- Enhances the national profile of HPS through new product developments and speaking/attendance at industry conferences/forums
- Develops relationships with all customers such as NHS Trusts and pharmaceutical companies, ensuring that the interests of the Trust are fully protected and that product development, sales and business opportunities are fully explored and acted upon
- Takes the lead role (where appropriate) in preparing submissions for Official Journal of the European Union (OJEU), national and regional tenders as appropriate. Ensures proper co-ordination with Trust Service Development and Finance departments.
- The creation of medicine registration dossiers containing required data for the submission and on-going maintenance of marketing authorisations
- Determine and specify storage, labelling and product packaging requirements for medicines
- 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.
The ideal candidate will have previous experience of working in R&D and as regulatory affairs professional within a pharmaceutical company and would have successfully prepared and submitted a number of marketing authorisations for medicinal products. He or she will be a natural leader, display sound project management skills, be self-motivated, a team player and be able to work well under pressure. The successful candidate will be able to demonstrate that they can bring something extra to a high performing organisation.
Job description
Job responsibilities
- Responsible for the strategic, effective and efficient use of external partners for the sourcing and development of APIs and other starting materials and associated formulation testing and analytical development services
- Prepare and manage budgets
- Write and complete relevant dossier sections for regulatory submission that cover (for example) product development, analysis and manufacturing processes
- Review proposed changes to regulated processes and /or products to identify regulatory implications in both pre-approval and post approval regimes
- Liaise (in conjunction with the Managing Director and quality personnel) with the MHRA, and other regulatory agencies for all formulation and development related topics for both pre- and post-approval
- Applicable to research and development, work closely with company senior management to provide strategic and operational planning for all aspects of sourcing and receipting of materials (supply chain management) from early development to commercialisation
- Interact with key scientific, clinical research, marketing and commercial personnel within and outside the company to ensure timely and accurate regulatory compliance on formulation matters
- Direct point of contact for external contractors/suppliers and internal staff
- Develops an understanding of market conditions and competitor developments
- Provides client and competitor information and intelligence to senior management
- Assists with the compilation of the annual business plan for HPS in conjunction with the senior management team and the finance department
- Assists in preparing and presenting business cases as necessary to secure the necessary funding for service development
- Enhances the national profile of HPS through new product developments and speaking/attendance at industry conferences/forums
- Develops relationships with all customers such as NHS Trusts and pharmaceutical companies, ensuring that the interests of the Trust are fully protected and that product development, sales and business opportunities are fully explored and acted upon
- Takes the lead role (where appropriate) in preparing submissions for Official Journal of the European Union (OJEU), national and regional tenders as appropriate. Ensures proper co-ordination with Trust Service Development and Finance departments.
- The creation of medicine registration dossiers containing required data for the submission and on-going maintenance of marketing authorisations
- Determine and specify storage, labelling and product packaging requirements for medicines
- 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.
The ideal candidate will have previous experience of working in R&D and as regulatory affairs professional within a pharmaceutical company and would have successfully prepared and submitted a number of marketing authorisations for medicinal products. He or she will be a natural leader, display sound project management skills, be self-motivated, a team player and be able to work well under pressure. The successful candidate will be able to demonstrate that they can bring something extra to a high performing organisation.
Person Specification
Qualifications
Essential
- Bachelors/PhD degree in pharmaceutical sciences, chemistry or related life science required
- Post graduate qualification in Pharmaceutical Regulatory Affairs
Experience
Essential
- Substantial knowledge of pharmaceutical R&D, manufacturing, clinical trials, and contract research; significant experience in industry as a regulatory and formulation development professional managing the pre-development to regulatory approval of medicinal products
- In-depth knowledge of medicine development strategies and the drug development process and relevant regulatory requirements as related to pharmaceutical formulations
- Highly experienced in manufacturing as well as technical transfers to commercial manufacturing
- Demonstrable high performing senior management leadership experience in the formulation development function of a pharmaceutical or biotech company
- Strong aptitude to think strategically with excellent analytical, communication, presentation, and writing skills
- A strong sense of initiative, urgency, drive, pragmatism and judgement - overall an ability to make things happen
- Evidence of delivering product development targets
- Proven background in research and development with evidence of leading R&D functions and managing development staff
Desirable
- Highly experienced in all phases of pharmaceutical development and experience in launching products globally
- Strong abilities in strategic business operations including management of external partnerships, planning and negotiating
Training
Essential
- Specific Regulatory Affairs training
Desirable
- Demonstrates commitment to CPD in order to maintain skills required.
Special Knowledge/ Expertise
Essential
- Knowledge of pharmaceutical formulation research and development acquired through degree and equivalent experience
- Regulatory affairs, clinical trials including Marketing Authorisations, eCTD etc
Desirable
- Sound knowledge of Health and Safety issues and ability to manage risk
Practical/Intellectual Skills/Personal Qualities
Essential
- Leadership and motivational skills
- Ability to introduce new and innovative work practices
- Project management skills
Person Specification
Qualifications
Essential
- Bachelors/PhD degree in pharmaceutical sciences, chemistry or related life science required
- Post graduate qualification in Pharmaceutical Regulatory Affairs
Experience
Essential
- Substantial knowledge of pharmaceutical R&D, manufacturing, clinical trials, and contract research; significant experience in industry as a regulatory and formulation development professional managing the pre-development to regulatory approval of medicinal products
- In-depth knowledge of medicine development strategies and the drug development process and relevant regulatory requirements as related to pharmaceutical formulations
- Highly experienced in manufacturing as well as technical transfers to commercial manufacturing
- Demonstrable high performing senior management leadership experience in the formulation development function of a pharmaceutical or biotech company
- Strong aptitude to think strategically with excellent analytical, communication, presentation, and writing skills
- A strong sense of initiative, urgency, drive, pragmatism and judgement - overall an ability to make things happen
- Evidence of delivering product development targets
- Proven background in research and development with evidence of leading R&D functions and managing development staff
Desirable
- Highly experienced in all phases of pharmaceutical development and experience in launching products globally
- Strong abilities in strategic business operations including management of external partnerships, planning and negotiating
Training
Essential
- Specific Regulatory Affairs training
Desirable
- Demonstrates commitment to CPD in order to maintain skills required.
Special Knowledge/ Expertise
Essential
- Knowledge of pharmaceutical formulation research and development acquired through degree and equivalent experience
- Regulatory affairs, clinical trials including Marketing Authorisations, eCTD etc
Desirable
- Sound knowledge of Health and Safety issues and ability to manage risk
Practical/Intellectual Skills/Personal Qualities
Essential
- Leadership and motivational skills
- Ability to introduce new and innovative work practices
- Project management skills
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).
Employer details
Employer name
Calderdale and Huddersfield NHS Foundation Trust
Address
Calderdale and Huddersfield NHS Foundation Trust
Gate 2 School Street West
Huddersfield
HD3 3ET
Employer's website
https://www.cht.nhs.uk (Opens in a new tab)
