Head of Regulatory Affairs

Head of Regulatory Affairs

A global Pharmaceutical firm is looking to enhance their UK Regulatory team with the hire of a Head of Regulatory Affairs.

The successful Head of RA can be based either at the Essex office near Braintree OR in the Guildford office.

This role is ideally suited to a Senior RA Manager who is ready to develop themselves with a Head of Regulatory Affairs position.

Although this is a global firm; the position will mostly be specific to the UK&I but there will be some exposure to EU markets.

JOB PURPOSE

Lead and manage Company UK Regulatory Affairs department.

Responsible for provision of an efficient and proactive Regulatory service to meet the business objectives and deadlines for Company in the UK and EU.

Is responsible for interactions with UK governmental agencies in all areas of responsibility, including MHRA, Department of Health and Home Office.

Oversee the review, preparation, submission and follow-up of regulatory submissions to the UK regulatory authorities, to high standards, to ensure that marketing authorisations are obtained and maintained in line with the company's plans and goals.

Develop and implement local UK registration strategies for commercialisation of products, both locally and in conjunction with the Company corporate team.

Assist the Head of Scientific Affairs in developing strategies to optimise the efficient running of the department and to manage the achievement of appropriate registrations. Identify issues which may impact on project time-frames.

Direct and oversee management of workload and personal development of staff.

Supervise and train other regulatory staff within department as required by the Head of Scientific Affairs.

KEY RESULTS/ACCOUNTABILITIES

Job Description

Utilise a comprehensive understanding of EU regulatory requirements for marketing authorisations and their application in the UK and Ireland, to enable regulatory submissions to be compiled in line with current requirements. Pro-actively review critical new legislation and guidance documents and disseminate to relevant parties information of importance to the business.

Plan and participate in the technical review and preparation of high quality regulatory submissions to the authorities within agreed timeframes.

Monitor the progress of submissions and organise the efficient preparation and submission of responses to deficiencies noted by regulatory authorities, facilitating the earliest possible approval. Inform the Head of Technical Services of deviations from regulatory schedules which may affect product supply.

Develop and implement regulatory strategies and be proactively involved in the decision-making process in order to achieve registrations in a timely manner and in line with company goals. Consider potential obstacles to approval of regulatory submissions and actively problem solve.

Management of Resources

• Responsible for setting and management of Company UK Regulatory Affairs budget.
• Adheres to company-defined processes for the selection of and agreement of commercial terms with vendors

People Leadership

• Performance manages the UK Regulatory Affairs team through setting and reviewing priorities. Provides appropriate and timely feedback about performance and coaches team members to help them achieve their goals
• Supports the professional and career development of the team by identifying the skills and competencies that employees need for their current and prospective roles and provide opportunities to learn and practice new skills
• Leads the building of a motivated and engaged team through the use of formal and informal recognition, regular communications and the encouragement of cooperation between individuals and teams

Ethical Leadership

• Takes personal accountability to use personal experience and knowledge, as well as the training and tools provided by Company, to maintain a good knowledge and understanding of all ethics and governance relevant to the role (including the Industry Code of Practice, Company Policies and Procedures and any relevant legal requirements); and demonstrate personal leadership in applying these to all work undertaken.
• Escalates any decisions, or seek the support of colleagues or management if personal knowledge and understanding is not at the level required to carry out any part of the role.

KEY WORKING RELATIONSHIPS

INTERNAL

Regular, close contact with:

1. Company Commercial team
2. Global Company Regulatory Affairs
3. Supply Chain
4. Medical Affairs
5. Pharmacovigilance
6. Quality
7. Manufacturing sites (regulatory site officers and packaging development teams)

Occasional contact with:

1. Legal
2. IS
3. Facilities.

EXTERNAL

Regular, close contact with:

1. MHRA
2. Trade Associations (BGMA)
3. Third party service providers

Occasional contact with:

1. Department of Health
2. Other Government healthcare bodies

SKILLS, EXPERIENCE & KNOWLEDGE REQUIREMENTS

• A degree in science (preferably a life science), with record of proven success in achieving regulatory approvals in the UK and /or Ireland
• Additional experience in the pharmaceutical industry in a related field is an advantage, in particular a knowledge of the regulatory issues associated with registration of generics
• A record of proven success in managing and supervising staff.
• A record of proven success in achieving regulatory approvals in the UK.
• Ability to manage multi-functional projects, and to assess detailed scientific information from a variety of disciplines.
• Good organisational skills and ability to manage multiple projects/priorities under pressure and to cope with tight deadlines. Ability to foresee and respond to potential problems and opportunities.

COMPETENCY REQUIREMENTS

LEVEL

Act for Change

Cooperate Transversely

Commit to Customers

Strive for Result

Think Strategically

Develop People

Makes Decisions

Lead Teams

The company offers very competitive rates and great benefits, including a generous bonus and car allowance.

Keywords:

Regulatory, Head of Regulatory, RA, Pharmaceuticals, Submissions, Management Skills, Strategy, Generics, Leadership, UK, EU