Director of Regulatory Strategy

1 week ago

London, Greater London, United Kingdom MSD Full time
Job Description

Overview

The Regulatory Affairs team at MSD plays a critical role in ensuring the smooth operation of all registration activities across the company's defined responsibilities. As an Associate Director of Regulatory Affairs, you will manage a team of Regulatory Affairs Specialists to enable the company to manufacture and market its products in the UK.

Key Responsibilities

  • Regulatory Strategy and Filing
    • Develop and implement regulatory strategies to support pediatric submissions, new marketing authorisation (MA) applications, and product launches.
    • Maintain and update marketing authorisations (MAs) through various regulatory procedures, including submission of variation applications.
  • MA Changes and Compliance
    • 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.
  • Regulatory Expertise and Representation
    • Develop and maintain a sound knowledge of UK and European regulatory requirements, regulations, and guidelines to provide advice and expertise internally.
    • Represent Regulatory Affairs at cross-functional meetings, including product acquisitions and ad-hoc product issues, compliance investigations, as required.
  • Team Management
    • Manage a small team of Regulatory Affairs Specialists, setting performance and development objectives, reviewing and advising on staff training and education needs.
    • Set and monitor compliance expectations for direct reports, ensuring regulatory activities are completed to the required standard.
  • Other Responsibilities
    • Maintain current awareness of the Regulatory environment, working knowledge of legislation, guidelines, and procedures.
    • Contribute to departmental projects and issues, working as a strong member of the UK regulatory team.
    • Participate in the preparation, processing, and training of written procedures to underpin regulatory activities, as required.

Requirements

To be successful in this role, you will have a strong understanding of UK and European regulatory requirements, regulations, and guidelines. You will also have excellent leadership and communication skills, with the ability to manage a team and represent Regulatory Affairs at cross-functional meetings.

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