Associate Director, Regulatory Affairs UK

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Our Regulatory Affairs team brings new medical advancements to the world by facilitating communications and procedures that allow swift, organised compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

The Regulatory Affairs team manages a broad portfolio of prescription medicines for the UK largely across the vaccine, oncology and infectious disease therapeutic areas.

A new opportunity has arisen in the UK Regulatory Affairs Department, at the Associate Director level. The individual would manage a team of Regulatory Affairs Specialists, to ensure the smooth operation of all registration activities across the teams defined responsibilities, to enable the company to manufacture and market its products in the UK. In addition to a defined product portfolio.

The role would be responsible for undertaking a variety of regulatory activities across a range of products for the UK market including:

• Developing regulatory strategy and supporting regulatory filing activities for peadiatric submissions, new marketing authorisation (MA) applications and product launches.
• Maintenance of marketing authorisations (MAs) working via a range of regulatory procedures including submission of variation applications across all aspects of registered particulars. This will include working with the MHRA to support review and obtain approval for changes.
• Implementation and communication of MA changes across internal stakeholder groups. Ensuring all compliance activities are correctly managed.
• Generation and maintenance of prescribing information, patient information leaflets and packaging components, including artwork management, which will be in line with regulatory requirements and company approval systems.
• Developing and maintaining a sound knowledge of UK and European regulatory requirements, regulations and guidelines to provide advice and expertise internally for matters related to our products.
• Working with the business to support product acquisitions, any arising product issues and product deletions and divestitures as required
• Utilising and supporting company compliance systems in relation to product responsibilities and meeting compliance expectations.
• Working with Global Regulatory Policy and other stakeholders to advocate for therapeutic areas/local positions on regulatory issues and shape the regulatory environment on selected issues through liaising with trade associations.

Management Activities

In addition to the above this includes the management of a small team of Regulatory Affairs Specialist direct reports for which responsibilities will include:

• Setting performance and development objectives towards division's and country's objectives, for each Specialist. Guiding and mentoring them in order to achieve them. Appraising staff formally at year end and as necessary informally throughout the year. Reviewing and advising on staff training and education needs.
• Setting and monitoring compliance expectations for direct reports and enabling resolutions where problems are seen. Ensuring regulatory activities are being completed to the required standard across the team through regular contact and support.
• Assisting and guiding direct report with new projects or regulations to ensure outcome is successful.
• Deputise where necessary for the Department Head and represent the department as appropriate on regulatory issues.

Other

• Maintain own current awareness of the Regulatory environment, and working knowledge of legislation, guidelines and procedures. Communicate and review issues and changes within the group to ensure a sound knowledge base within the department.
• Build and maintain sound working relationships with the MHRA. Maintains a positive relationship with internal regulatory contacts.
• Working as a strong member of the UK regulatory team, contributing to departmental projects and issues.
• In collaboration with the Department Head, participate in the preparation, processing and training of written procedures to underpin the various regulatory activities as required. Undertake the necessary training prior to performing relevant tasks and ensure on-going compliance with the required processes.
• Assist in the preparation for PV Inspection and other Audits as relevant and ensure that the regulatory component of these inspections are supported.

Qualifications:

• BSc. Degree or higher (or equivalent qualifications/experience) in pharmacy or a life-science subject.

Experience Required:

• A minimum of 4 years of experience working in a regulatory affairs related role in the pharmaceutical industry is required with sound knowledge and experience of EU/UK regulatory procedures and requirements (including post Brexit) and a good understanding of EU and UK Medicines Legislation.
• Experience in managing a team or supervising or mentoring others.
• Experience of working with a Regulatory Authority, ideally the MHRA.

Skills/Knowledge Required:

• Able to oversee and manage the work of others and provide leadership and direction.
• Excellent verbal and written communication skills, demonstrate proficiency in English language, with the ability to interact with a wide range of people both internal and external, including the Regulatory Agency. And demonstrate diplomacy and assertiveness skills in dealing with internal and external parties
• Meticulous attention to detail and be flexible enough to successfully handle conflicting time pressures and a large volume of work on own initiative. Also to work effectively within the Reg Affairs team and with other stakeholders to deliver on Company Objectives and Goals.
• Able to work within and embrace a changing UK regulatory environment, taking onboard new information and requirements and applying it effectively to daily work.
• Able to demonstrate a genuine interest and knowledge of the regulatory environment and a desire to succeed in a regulatory affairs role in the pharmaceutical industry.