Current jobs related to Regulatory Affairs Director - London, Greater London - MSD

  • Regulatory Affairs Specialist

    1 month ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs Officer OpportunityA rare chance to kickstart your career in chemical regulatory affairs with a global chemical products business.Key Responsibilities:Work under the supervision of an experienced regulatory manager to provide regulatory support for a wide range of chemical products.Conduct a range of activities, including SDS authoring,...

  • Regulatory Affairs Specialist

    1 month ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs Officer OpportunityA rare chance to kickstart your career in chemical regulatory affairs with a global chemical products business.Key Responsibilities:Work under the supervision of an experienced regulatory manager to provide regulatory support for a wide range of chemical products.Conduct a range of activities, including SDS authoring,...

  • Regulatory Affairs Specialist

    2 months ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Job DescriptionA rare opportunity for an aspiring regulatory affairs professional to join the regulatory team at a global chemical products business:Work under the supervision of an experienced regulatory managerProvide regulatory support to a wide range of chemical productsOngoing and comprehensive trainingAn excellent opportunity to start and establish...

  • Regulatory Affairs Specialist

    2 months ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Job DescriptionA rare opportunity for an aspiring regulatory affairs professional to join the regulatory team at a global chemical products business:Work under the supervision of an experienced regulatory managerProvide regulatory support to a wide range of chemical productsOngoing and comprehensive trainingAn excellent opportunity to start and establish...

  • Regulatory Affairs Specialist

    1 month ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs OpportunityA unique chance to launch your career in chemical regulatory affairs with VRS Regulatory, a specialist scientific recruiter.About the Role:Work under the guidance of an experienced regulatory manager to provide support for a diverse range of chemical products.Conduct a variety of activities, including SDS authoring, updates,...

  • Regulatory Affairs Specialist

    1 month ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs OpportunityA unique chance to launch your career in chemical regulatory affairs with VRS Regulatory, a specialist scientific recruiter.About the Role:Work under the guidance of an experienced regulatory manager to provide support for a diverse range of chemical products.Conduct a variety of activities, including SDS authoring, updates,...

  • Regulatory Affairs Specialist

    1 month ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs Officer OpportunityA rare chance to kick-start your career in chemical regulatory affairs with a global chemical products business.Key Responsibilities:Work under the supervision of an experienced regulatory manager to provide regulatory support to a wide range of chemical products.Conduct a range of activities to support a broad product...

  • Regulatory Affairs Specialist

    1 month ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs Officer OpportunityA rare chance to kick-start your career in chemical regulatory affairs with a global chemical products business.Key Responsibilities:Work under the supervision of an experienced regulatory manager to provide regulatory support to a wide range of chemical products.Conduct a range of activities to support a broad product...

  • Regulatory Affairs Specialist

    1 month ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs OpportunityA rare chance to start your career in chemical regulatory affairs with a global chemical products business.Key Responsibilities:Work under the supervision of an experienced regulatory manager to provide regulatory support to a wide range of chemical products.Conduct a range of activities to support a broad product portfolio,...

  • Regulatory Affairs Specialist

    1 month ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs OpportunityA rare chance to start your career in chemical regulatory affairs with a global chemical products business.Key Responsibilities:Work under the supervision of an experienced regulatory manager to provide regulatory support to a wide range of chemical products.Conduct a range of activities to support a broad product portfolio,...

  • Regulatory Affairs Specialist

    1 month ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs OpportunityA rare chance to start your career in chemical regulatory affairs with VRS Regulatory, a specialist scientific recruiter.About the Role:As a Regulatory Affairs Specialist, you will work under the supervision of an experienced regulatory manager, providing regulatory support to a wide range of chemical products. You will be...

  • Regulatory Affairs Specialist

    1 month ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs OpportunityA rare chance to start your career in chemical regulatory affairs with VRS Regulatory, a specialist scientific recruiter.About the Role:As a Regulatory Affairs Specialist, you will work under the supervision of an experienced regulatory manager, providing regulatory support to a wide range of chemical products. You will be...

  • Regulatory Affairs Specialist

    1 month ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs Officer OpportunityA rare chance to kickstart your career in chemical regulatory affairs with a global chemical products business.Key Responsibilities:Work under the guidance of an experienced regulatory managerProvide regulatory support for a diverse range of chemical productsParticipate in ongoing and comprehensive trainingYou will be...

  • Regulatory Affairs Specialist

    1 month ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs Officer OpportunityA rare chance to kickstart your career in chemical regulatory affairs with a global chemical products business.Key Responsibilities:Work under the guidance of an experienced regulatory managerProvide regulatory support for a diverse range of chemical productsParticipate in ongoing and comprehensive trainingYou will be...

  • Regulatory Affairs Manager

    2 weeks ago

    London, Greater London, United Kingdom Turner Regulatory Full time

    Regulatory Affairs ManagerTurner Regulatory is seeking a highly skilled Regulatory Affairs Manager to join our team. The successful candidate will have a background in European Market Regulatory activity and excellent commercial awareness.Key Responsibilities:Liaise closely with Business Development, Regulatory Science, Pharmacovigilance, Product Launch,...

  • Regulatory Affairs Director

    2 weeks ago

    London, Greater London, United Kingdom Reed Specialist Recruitment Ltd Full time

    Job Title: Regulatory Affairs DirectorWe are seeking an experienced Regulatory Affairs Director to lead our regulatory affairs team. The successful candidate will be responsible for developing and implementing regulatory strategies aligned with our company's strategic objectives.Main Responsibilities:* Develop and implement regulatory strategies* Lead and...

  • Regulatory Affairs Director

    2 weeks ago

    London, Greater London, United Kingdom city of San Elizario Full time

    Regulatory Affairs DirectorWe are seeking a highly experienced Regulatory Affairs Director to join our team in San Elizario. As a key member of our organization, you will play a pivotal role in shaping our regulatory strategy and contributing to the growth and success of our clients' investigational products.Key Responsibilities:Regulatory Strategy...

  • Regulatory Affairs Director

    2 weeks ago

    London, Greater London, United Kingdom CITY OF SAN ELIZARIO Full time

    Regulatory Affairs DirectorWe are seeking a highly experienced Regulatory Affairs Director to join our team at CITY OF SAN ELIZARIO. As a key member of our Senior Leadership Team, you will be responsible for developing and implementing regulatory strategies to expedite the approval process for investigational products.Key Responsibilities:Develop and...

  • Regulatory Affairs Director

    1 month ago

    London, Greater London, United Kingdom GlaxoSmithKline Full time

    Job Title: Director, Regulatory AffairsGlaxoSmithKline is seeking a highly skilled and experienced Director, Regulatory Affairs to join our team. As a key member of our regulatory affairs team, you will be responsible for ensuring the development and execution of appropriate regional regulatory strategies and their execution for assigned assets consistent...

  • Regulatory Affairs Director

    7 days ago

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

    Job Title: Associate Regulatory Affairs DirectorJob Summary:We are seeking a highly skilled and experienced Regulatory Affairs Director to join our team at Merck Gruppe - MSD Sharp & Dohme. As a key member of our Regulatory Affairs Department, you will be responsible for managing a team of Regulatory Affairs Specialists and ensuring the smooth operation of...

Regulatory Affairs Director

2 months ago

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

**About the Role**

We are seeking a highly skilled and experienced Regulatory Affairs Director to join our team at MSD. As an Associate Director, Regulatory Affairs, you will play a key role in managing a team of Regulatory Affairs Specialists and ensuring the smooth operation of all registration activities across the team's defined responsibilities.

**Key Responsibilities**

  • Develop and implement regulatory strategies to support pediatric submissions, new marketing authorisation (MA) applications, and product launches.
  • Maintain marketing authorisations (MAs) through various regulatory procedures, including submission of variation applications and working with the MHRA to support review and obtain approval for changes.
  • 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.
  • Utilise and support company compliance systems in relation to product responsibilities and meet compliance expectations.
  • 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**

In addition to the above, this role includes the management of a small team of Regulatory Affairs Specialist direct reports, with responsibilities including:

  • Setting performance and development objectives for each Specialist, guiding and mentoring them to achieve these objectives, and appraising staff formally at year end and as necessary informally throughout the year.
  • 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.
  • Deputising where necessary for the Department Head and representing the department as appropriate on regulatory issues.

**Other Responsibilities**

  • Maintain own 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.
  • Build and maintain sound working relationships with the MHRA and maintain a positive relationship with internal regulatory contacts.
  • Work 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, undertaking the necessary training prior to performing relevant tasks and ensuring ongoing compliance with the required processes.
  • Assist in the preparation for PV Inspection and other Audits as relevant, ensuring that the regulatory component of these inspections are supported.