Head of Regulatory

**Job Title**: Head of Regulatory - Medicines, Medical Devices and Borderline products
**Location**: Barnstaple / Nottingham / Ireland / Designated place of work
**Purpose of Job**
- To provide leadership to the regulatory teams
- To provide strategic advice and guidance on client projects
- To provide regulatory support for other JensonR+ departments
- Direct line management of regulatory team members
- Co-ordinate all regulatory team resources and regulatory activity, considering deadlines andbudgets, reviewing weekly and monthly plans to ensure resource capacity is utilised fully
- Involvement in management activities as required to improve JensonR+ operations
- Input and participate in Business Development activities
**Qualifications and Role Requirements**
- At least 10 years Regulatory Affairs experience in two of the disciplines, medical devices,borderline products or medicines.
- Scientific academic qualification or extensive relevant experience in the pharmaceuticalindustry
- Knowledge of relevant guidance in EU and GB for medicines
- At least five years line management experience
- Ability to solve routine problems and to manage issues constructively.
- Act autonomously where appropriate, take initiatives and make decisions with a clearunderstanding of the consequences and potential next steps.
- Ability to communicate verbally and in written format, concise and meaningful informationto support actions, decisions and proposals.
- Supervise a cross functional team, as required.
**Relevant Regulation and related issues**
- Human Medicines Regulations 2012 and Statutory Instruments.
- Data Protection legislation.
- Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March2004 laying down Community procedures for the authorisation and supervision of medicinalproducts for human and veterinary use and establishing a European Medicines Agency, asamended
- Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 onthe Community code relating to medicinal products for human use, as amended
- Working knowledge of Food Law and applicable regulations in EU & GB
- Working knowledge of Medical Device regulation/guidance EU & UK/GB
- Health and Safety at Work etc Act 1974
**Relationships**
Responsibility to: Director, JensonR+ Limited
Direct relationships: Regulatory Managers
Regulatory team
CEO & Directors
JensonR+ Management team
QPPV & QP
Other JensonR+ staff
External development partners and clients
External consultants and contractors
Regulatory Authorities regulanet+ partners
regenold GmBH and CE Plus
Direct reports: Regulatory Team members as appropriate
Indirect relationships: Clients of regenold GmBH (CE Plus)
**Limits of Role**
The Head of Regulatory is responsible for authorisation of, and must seek authority for, external expenditure.
**Main Duties and Responsibilities**
- Provide leadership of the regulatory team
- Provide strategic advice and input to new projects
- Lead authority meetings with clients
- Oversight of all European projects
- Preparation and submission of strategic documentation to regulatory agencies on behalf of clients.
- Identify problems and solutions for operation of regulatory team, through regular dialogue with team members
- Maintenance of high quality internal records and documentation linked to all areas of the JensonR+ business
- Regulatory project management
- Providing regulatory support and advice to other areas of the business,
- Training and mentoring new regulatory staff members
- Liaison with suppliers, clients, development partners and regulatory bodies
- Ensure guidelines and legislation knowledge is current
- To have good awareness of future developments in the regulatory arena by CPD
- Ensure knowledge of JensonR+ SOPs is current & recorded, according to training matrix relevant to the role
- To assist management in development of departmental systems and procedures
- Assisting in growth of the regulatory consultancy business - business development proposals, external meetings, presentations and training as required
- To partake when needed in client meetings and meetings with competent authorities

**General responsibilities**
All employees of JensonR+ Ltd have a responsibility under the Health and Safety at Work etc Act 1974 to ensure their own and other’s safety whilst at work and to be aware and work within the framework of Jenson’s Health and Safety Policy and the associated Standard Operating Procedures.Notes

Key skills
- Needs to be comfortable leading team of up to 5 5 direct reports, including medical devices, along with 11 indirect reports
- Competent in UK and EU regulatory affairs
- Strategic thinking
- Confident to negotiate new proposals and be active in business development.

Pay: £60,000.00-£80,000.00 per year

**Benefits**:

- Additional leave
- Company events
- Company pension
- Cycle to work scheme
- Private medical insurance
- Sick pay

Schedule:

- Monday to Friday

Work Location: Hy