Senior Manager, Global Labeling Strategy

5 days ago

United Kingdom G&L Healthcare Advisors Full time

We are currently looking for a Senior Manager, Global Labeling Strategy to join us at G&L Healthcare.


The Senior Manager, Global Labeling Strategy has overall accountability for relevant updates to labeling documents (Company Core Data Sheet (CCDS), United States Package Inserts (USPI) and EU Summary of Product Characteristics (SmPC) for products registered via the centralized, Mutual Recognition or Decentralized Procedure.


Key Responsibilities include:


  • Drives labeling strategy in partnership with the Global Regulatory Team Leader in line with the overall regulatory Strategy by providing labeling expertise (labeling regulations, internal processes and competitor analyses) for CCDS, USPI and SmPC (Centralized / Mutual Recognition / Decentralized Procedure) for medium to low complex projects in the Lifecycle Management (LCM) projects
  • Serves as primary contact for cross-functional Labeling Team Member , Global Regulatory Lead , Safety Management Team Lead , Functional SMEs, Documentation Leads and Medical Writer, Dossier Lead and Submission Manager, also serves as interface for Country Regulatory Managers to support timely and quality submissions globally
  • Coordinates labeling activities of multifunctional contributors, reviewers and approvers and manages the label review and approval process to maximize speed and quality
  • Ensures effective planning of all cross-functional labeling activities
  • Reviews country labels to ensure labeling compliance
  • Support responses to labeling related inquiries from Global Health Authorities and related to inspection activities
  • Participates in key initiatives (Process Improvements, Development of new tools, technologies) to support efficient global label development and worldwide submissions and approvals


Requirements and skills:


  • Masters of Life Sciences or equivalent, with thorough understanding of scientific principles or Bachelor of Life Sciences with at least 2 years of Labeling/Regulatory Experience
  • Good Understanding of Drug Development and Commercialization of prescription medicines
  • Ability to understand regulatory implications of product strategy related to labeling development, assessment and management
  • Experience in managing medium complex projects
  • Keen attention to detail and accuracy
  • Ability to assimilate clinical and scientific information and present it in a concise manner
  • Ability to think creatively and good excellent problem-solving skills
  • Ability to develop strong and positive working relationships across diverse teams and within a global environment
  • Ability to influence and lead a diverse group of Subject Matter Experts from a variety of disciplines and facilitate discussions and decision making


G&L Healthcare Advisors is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status or race.

  • Senior Manager, Global Labeling Strategy

    5 days ago

    United Kingdom G&L Healthcare Advisors Full time

    We are currently looking for a Senior Manager, Global Labeling Strategy to join us at G&L Healthcare. The Senior Manager, Global Labeling Strategy has overall accountability for relevant updates to labeling documents (Company Core Data Sheet (CCDS), United States Package Inserts (USPI) and EU Summary of Product Characteristics (SmPC) for products...

  • Senior Manager, Global Labeling Strategy

    5 days ago

    United Kingdom G&L Healthcare Advisors Full time

    We are currently looking for a Senior Manager, Global Labeling Strategy to join us at G&L Healthcare. The Senior Manager, Global Labeling Strategy has overall accountability for relevant updates to labeling documents (Company Core Data Sheet (CCDS), United States Package Inserts (USPI) and EU Summary of Product Characteristics (SmPC) for products...

  • Senior Manager, Global Labeling Strategy

    2 weeks ago

    United Kingdom G&L Healthcare Advisors Full time

    We are currently looking for a Senior Manager, Global Labeling Strategy to join us at G&L Healthcare.The Senior Manager, Global Labeling Strategy has overall accountability for relevant updates to labeling documents (Company Core Data Sheet (CCDS), United States Package Inserts (USPI) and EU Summary of Product Characteristics (SmPC) for products registered...

  • Senior Manager, Global Labeling Strategy

    2 weeks ago

    United Kingdom G&L Healthcare Advisors Full time

    We are currently looking for a Senior Manager, Global Labeling Strategy to join us at G&L Healthcare.The Senior Manager, Global Labeling Strategy has overall accountability for relevant updates to labeling documents (Company Core Data Sheet (CCDS), United States Package Inserts (USPI) and EU Summary of Product Characteristics (SmPC) for products registered...

  • Regulatory Labelling Contractor

    1 week ago

    United Kingdom X4 Life Sciences Full time

    Regulatory Labelling Contract:I’m working with a pharmaceutical company in the UK dedicated to improving healthcare as they look for a Freelance Labelling Contractor.Key Details:Fully remote role – anywhere in the EU6 to 12 month contractKnowledge of CCDS, EUspi and UspiKey Responsibilities:Prepare regulatory labelling packages in collaboration with the...

  • Senior Manager

    2 days ago

    United Kingdom G&L Healthcare Advisors Full time

    The Senior Manager, Global Labeling Strategy has overall accountability for relevant updates to labeling documents (Company Core Data Sheet (CCDS), United States Package Inserts (USPI) and EU Summary of Product Characteristics (SmPC) for products registered via the centralized, Mutual Recognition or Decentralized Procedure. Drives labeling strategy in...

  • Director, Regulatory Strategy

    5 days ago

    United Kingdom Planet Pharma Full time

    Planet Pharma is pleased to be recruiting for a temporary Director EU Regulatory Strategy to work on an initial 6 months basis fully remote in the UK. Serve as a thought leader on regulatory affairs, defining European regulatory strategy and plan to maximize regulatory success · Provide strategic and operational input to program team to achieve program...

  • Director, Regulatory Strategy

    5 days ago

    United Kingdom Planet Pharma Full time

    Planet Pharma is pleased to be recruiting for a temporary Director EU Regulatory Strategy to work on an initial 6 months basis fully remote in the UK. Serve as a thought leader on regulatory affairs, defining European regulatory strategy and plan to maximize regulatory success · Provide strategic and operational input to program team to achieve program...

  • Head of Operations and Strategy

    6 months ago

    United Kingdom Insulet Corporation Full time

    Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating. - We...

  • Wholesales Manager

    3 days ago

    United Kingdom Anya Hindmarch Full time

    Department Wholesale Reporting to Head of Business Development Location Head Office/London Hours Full time We are looking for an exceptional Senior Wholesale Manager to join our team. We are looking for a senior candidate to help shape the future of our wholesale business and other commercial opportunities. Anya Hindmarch creates four...

  • Senior Institutional Memberships and Global Networks Manager

    3 weeks ago

    United Kingdom AMEE - The International Association for Health Professions Education Full time

    AMEE, the international association for health professions education, is growing. Known globally for its membership community, portfolio of educational products and resources, and industry-leading annual conference, AMEE is in an exciting period of development. Building on its existing services and unrivalled reputation, it is entering a period of strategic...

  • Senior Institutional Memberships and Global Networks Manager

    3 weeks ago

    United Kingdom AMEE - The International Association for Health Professions Education Full time

    AMEE, the international association for health professions education, is growing. Known globally for its membership community, portfolio of educational products and resources, and industry-leading annual conference, AMEE is in an exciting period of development. Building on its existing services and unrivalled reputation, it is entering a period of strategic...

  • Senior Institutional Memberships and Global Networks Manager

    3 weeks ago

    United Kingdom AMEE - The International Association for Health Professions Education Full time €42,000

    AMEE, the international association for health professions education, is growing. Known globally for its membership community, portfolio of educational products and resources, and industry-leading annual conference, AMEE is in an exciting period of development. Building on its existing services and unrivalled reputation, it is entering a period of strategic...

  • Strategy Manager

    3 days ago

    United Kingdom rmg digital Full time €400

    A unique opportunity has arisen for a talented Programme Planning Manager to join an ambitious global transformation programme. This high-impact role will oversee integrated planning across multiple complex projects, ensuring the seamless design, delivery, and deployment of cutting-edge solutions. Location: London (Hybrid) You’ll be instrumental in...

  • Reward Equity

    5 days ago

    United Kingdom JAM Recruitment Full time

    Reward Equity & Global Share Schemes Manager / Senior Manager Job Type: Permanent Location: Remote Role (UK Wide) The successful candidate will be responsible for leading a team of experienced reward equity professionals and advising business leaders regarding reward equity/bonus policy development and implementation, process design and...

  • Reward Equity

    5 days ago

    United Kingdom JAM Recruitment Full time

    Reward Equity & Global Share Schemes Manager / Senior Manager Job Type: Permanent Location: Remote Role (UK Wide) The successful candidate will be responsible for leading a team of experienced reward equity professionals and advising business leaders regarding reward equity/bonus policy development and implementation, process design and...

  • Global Compensation

    4 months ago

    United Kingdom Socrates Global Full time

    Who Are We and What Do We Do?Socrates is a social media platform in the era of AI & Web3. It's named "Socrates" since it promotes the critical thinking approach to all information and encourages humanity to view the world critically.We are seeking a dynamic and experienced Global C&B Specialist or Assistant C&B Manager. The right candidate will assist in...

  • Global Compensation

    4 months ago

    United Kingdom Socrates Global Full time

    Who Are We and What Do We Do?Socrates is a social media platform in the era of AI & Web3. It's named "Socrates" since it promotes the critical thinking approach to all information and encourages humanity to view the world critically.We are seeking a dynamic and experienced Global C&B Specialist or Assistant C&B Manager. The right candidate will assist in...

  • Global Compensation

    4 months ago

    United Kingdom Socrates Global Full time

    Who Are We and What Do We Do? Socrates is a social media platform in the era of AI & Web3. It's named "Socrates" since it promotes the critical thinking approach to all information and encourages humanity to view the world critically. We are seeking a dynamic and experienced Global C&B Specialist or Assistant C&B Manager. The right candidate will...

  • Global Compensation

    5 days ago

    United Kingdom Socrates Global Full time

    Who Are We and What Do We Do? Socrates is a social media platform in the era of AI & Web3. It's named "Socrates" since it promotes the critical thinking approach to all information and encourages humanity to view the world critically. We are seeking a dynamic and experienced Global C&B Specialist or Assistant C&B Manager. The right candidate will...