Associate Director Regulatory

1 week ago

London, Greater London, United Kingdom MSD Full time

Job Summary

The Regulatory Affairs team at MSD manages a broad portfolio of prescription medicines for the UK market, primarily 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, ensuring the smooth operation of all registration activities across the team's defined responsibilities, to enable the company to manufacture and market its products in the UK.

Key Responsibilities

  • Develop and implement regulatory strategies and support regulatory filing activities for pediatric submissions, new marketing authorization (MA) applications, and product launches.
  • Maintain marketing authorizations (MAs) through various regulatory procedures, including submission of variation applications across all aspects of registered particulars.
  • Implement and communicate MA changes across internal stakeholder groups, ensuring all compliance activities are correctly managed.
  • Generate and maintain prescribing information, patient information leaflets, and packaging components, in line with regulatory requirements and company approval systems.
  • Develop and maintain a sound knowledge of UK and European regulatory requirements, regulations, and guidelines to provide advice and expertise internally for matters related to our products.
  • Represent Regulatory Affairs at cross-functional meetings, including product acquisitions and ad-hoc product issues, compliance investigations, as required.
  • Advocate for therapeutic areas/local positions on regulatory issues and trends internally and externally, contributing to a broader policy platform.
  • Utilize and support company compliance systems in relation to product responsibilities and meet compliance expectations.
  • Collaborate 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 liaison with trade associations.

Management Activities

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

  • Setting performance and development objectives towards division's and country's objectives, for each Specialist. 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 reports with new projects or regulations to ensure outcomes are successful.
  • Deputizing where necessary for the Department Head and representing the department as appropriate on regulatory issues.

Other

  • Maintain own current awareness of the Regulatory environment, and working knowledge of legislation, guidelines, and procedures. Maintain 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 ongoing 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.

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