Regulatory Affairs Associate Director

1 month ago

London, Greater London, United Kingdom Merck Gruppe - MSD Sharp & Dohme Full time
Job Title: Associate Director of Regulatory Affairs

The Regulatory Affairs team at Merck Gruppe - MSD Sharp & Dohme plays a crucial role in managing a broad portfolio of prescription medicines for the UK market. We are seeking an experienced Associate Director of Regulatory Affairs to join our team and lead the development of regulatory strategies and support regulatory filing activities for pediatric submissions, new marketing authorisation applications, and product launches.

Key Responsibilities:
  1. Develop and implement regulatory strategies to ensure compliance with UK and European regulatory requirements.
  2. Manage a team of Regulatory Affairs Specialists to ensure the smooth operation of all registration activities across the teams defined responsibilities.
  3. 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.
  4. Represent Regulatory Affairs at cross-functional meetings, including product acquisitions and ad-hoc product issues, compliance investigations, as required.
  5. Advocate for therapeutic areas/local positions on regulatory issues and trends internally and externally, contributing to a broader policy platform.
  6. Utilize and support company compliance systems in relation to product responsibilities and meet compliance expectations.
  7. Work 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:
  1. Set performance and development objectives for each Specialist, reviewing and advising on staff training and education needs.
  2. Set and monitor compliance expectations for direct reports and enable resolutions where problems are seen, ensuring regulatory activities are completed to the required standard across the team.
  3. Assist and guide direct reports with new projects or regulations to ensure successful outcomes.
  4. Deputise where necessary for the Department Head and represent the department as appropriate on regulatory issues.
Other:
  1. Maintain current awareness of the Regulatory environment and working knowledge of legislation, guidelines, and procedures, maintaining a positive relationship with internal regulatory contacts.
  2. Contribute to departmental projects and issues as a strong member of the UK regulatory team.
  3. Participate in the preparation, processing, and training of written procedures to underpin regulatory activities, undertaking necessary training prior to performing relevant tasks and ensuring ongoing compliance with required processes.
  4. Assist in the preparation for PV Inspection and other Audits as relevant, ensuring the regulatory component of these inspections is supported.

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