Regulatory Affairs Director

4 weeks ago

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

Job Overview

The Regulatory Affairs team at Merck Gruppe - MSD Sharp & Dohme manages a broad portfolio of prescription medicines for the UK, primarily across vaccine, oncology, and infectious disease therapeutic areas.

We are seeking an experienced Associate Director to lead a team of Regulatory Affairs Specialists, ensuring the smooth operation of all registration activities across the team's defined responsibilities. This role will enable the company to manufacture and market its products in the UK, with a defined product portfolio.

The successful candidate will be responsible for undertaking various regulatory activities across a range of products for the UK market, including:

  1. Developing regulatory strategies and supporting regulatory filing activities for pediatric submissions, new marketing authorisation (MA) applications, and product launches.
  2. Maintenance of marketing authorisations (MAs) through regulatory procedures, including submission of variation applications across all aspects of registered particulars. This will involve working with the MHRA to support review and obtain approval for changes.
  3. Implementation and communication of MA changes across internal stakeholder groups, ensuring all compliance activities are correctly managed.
  4. Generation and maintenance of prescribing information, patient information leaflets, and packaging components, in line with regulatory requirements and company approval systems.
  5. 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.
  6. Representation of Regulatory Affairs at cross-functional meetings, including product acquisitions and ad-hoc product issues, compliance investigations, as required.
  7. Advocating for therapeutic areas/local positions on regulatory issues and trends internally and externally, contributing to a broader policy platform.
  8. Utilizing and supporting company compliance systems in relation to product responsibilities and meeting compliance expectations.
  9. Collaborating 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 Responsibilities

The successful candidate will also be responsible for managing a small team of Regulatory Affairs Specialists, including:

  1. Setting performance and development objectives for each Specialist, guiding and mentoring them to achieve these objectives. Formal appraisals will be conducted at year-end, with informal reviews throughout the year. Staff training and education needs will be reviewed and advised upon.
  2. Setting and monitoring compliance expectations for direct reports, enabling resolutions where problems arise. Ensuring regulatory activities are completed to the required standard across the team through regular contact and support.
  3. Assisting and guiding direct reports with new projects or regulations to ensure successful outcomes.
  4. Deputizing where necessary for the Department Head and representing the department on regulatory issues.

Additional Responsibilities

  1. Maintaining current awareness of the Regulatory environment and working knowledge of legislation, guidelines, and procedures. Communicating and reviewing issues and changes within the group to ensure a sound knowledge base within the department.
  2. Building and maintaining sound working relationships with the MHRA and internal regulatory contacts.
  3. Contributing to departmental projects and issues as a strong member of the UK regulatory team.
  4. Participating in the preparation, processing, and training of written procedures to underpin regulatory activities, as required. Undertaking necessary training prior to performing relevant tasks and ensuring ongoing compliance with required processes.
  5. Assisting in the preparation for PV Inspection and other Audits, ensuring the regulatory component of these inspections is supported.

This is an exciting opportunity to join our team and contribute to the success of Merck Gruppe - MSD Sharp & Dohme in the UK.

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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