Associate Director, Regulatory Affairs UK
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 pediatric submissions, new marketing authorization (MA) applications and product launches.
- Maintenance of marketing authorizations (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.
- Representation of Regulatory Affairs at cross functional meetings including product acquisitions and ad-hoc product issues, compliance investigations, as required.
- Advocates for therapeutic areas/local positions on regulatory issues and trends internally and externally contributing to a broader policy platform.
- 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.
#J-18808-Ljbffr
