Regulatory Affairs Associate Director

Job Description

The Regulatory Affairs team manages a broad portfolio of prescription medicines for the UK largely across the vaccine, oncology, cardiovascular 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 their own 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 paediatric submissions, new marketing authorisation (MA) applications and product launches.
• Maintenance of 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 Product Information, including Summary of Product Characteristics, patient information leaflets and packaging components (including artwork management), which will be in line with regulatory requirements and company approval systems.
• Developing and maintaining own current awareness of the Regulatory environment of UK and European regulatory legislation, requirements and guidelines to provide advice and expertise internally for matters related to our products. Communicate and review issues and changes within the group to ensure a sound knowledge base within the department.
• Representation of Regulatory Affairs at cross functional meetings including product acquisitions and ad-hoc product issues, compliance investigations, as required.
• Utilising and supporting company compliance systems in relation to product responsibilities and meeting compliance expectations. Manage and support non-compliance investigations.
• 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 outcomes against the defined priorities. 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

• 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, Skills and Experience

• Must hold a MS degree in pharmacy or other life science or equivalent. Extensive experience in a Registration Department, dealing with most aspects of registration and experience in supervising others. A sound appreciation of the interactions and relationships of the dept with other groups internally is expected. Must have client-oriented approach and work according to our organization leadership vision.
• The incumbent must be familiar with local and EU legislation procedures and guidelines governing pharmaceutical products. And have experience working with Health Authorities.
• Ability to communicate well verbally and in writing is essential, as are good organisational and planning skills. The incumbent should possess a meticulous attention to detail and be flexible enough to successfully handle conflicting time pressures and a large volume of work. A mature and disciplined approach to work is essential as is the ability to coordinate the work of others. The incumbent should be able to demonstrate diplomacy and assertive skills in dealing with internal and external parties.
• The incumbent must demonstrate proficiency in English language as well as in using the PC for all tasks such as word-processing, spreadsheets, database application, and internet.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Closing date for applications: 18/02/2025

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