Regulatory Affairs Associate Director

4 weeks ago

London, Greater London, United Kingdom Merck Gruppe - MSD Sharp & Dohme Full time
Job Description

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, primarily across vaccine, oncology, and infectious disease therapeutic areas.

We are seeking an experienced Associate Director of Regulatory Affairs to join our UK Regulatory Affairs Department. In this role, you will manage a team of Regulatory Affairs Specialists, ensuring the smooth operation of all registration activities across the team's defined responsibilities, enabling the company to manufacture and market its products in the UK.

Key Responsibilities
  1. Develop and implement regulatory strategies to support pediatric submissions, new marketing authorisation (MA) applications, and product launches.
  2. Maintain marketing authorisations (MAs) through various regulatory procedures, including submission of variation applications across all aspects of registered particulars.
  3. Implement and communicate MA changes across internal stakeholder groups, ensuring compliance activities are correctly managed.
  4. Generate and maintain prescribing information, patient information leaflets, and packaging components, adhering to regulatory requirements and company approval systems.
  5. 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.
  6. Represent Regulatory Affairs at cross-functional meetings, including product acquisitions and ad-hoc product issues, compliance investigations, as required.
  7. Advocate for therapeutic areas/local positions on regulatory issues and trends internally and externally, contributing to a broader policy platform.
  8. Utilize and support company compliance systems in relation to product responsibilities and meet compliance expectations.
  9. 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
  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, enabling resolutions where problems are seen, and ensuring regulatory activities are completed to the required standard across the team through regular contact and support.
  3. Assist and guide direct reports with new projects or regulations to ensure successful outcomes.
  4. Deputise for the Department Head and represent the department as appropriate on regulatory issues.
Additional Responsibilities
  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.

Employee Status: Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:10/16/2024

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