GRCY-0, Regulatory Affairs Manager

3 days ago

London, Greater London, United Kingdom Merck Serono Ltd. Full time £60,000 - £120,000 per year

Your role: 

We have an exciting opportunity for a Regulatory Affairs Manager role to join our regulatory team in the UK. In this position, you will be responsible for key regulatory activities for the UK and Republic of Ireland, including necessary interactions with Health Authorities to ensure the maintenance of Marketing Authorisations for the company's product portfolio. Your tasks will encompass the life cycle management of marketed products as well as the registration of new compounds, including potential Early Access Programmes for new assets.

Key responsibilities include:

  • Drive in country submission management from planning to finalizing local submissions (including review and approval of dossiers, new documentation for label and artwork when applicable).
  • Drive local cross-functional alignment and quality control of regulatory applications/documentation in accordance with regional and local regulatory requirements
  • Serve as the point of contact for Health Authorities to foster and maintain close relationships.
  • Support Named Patient programs and Early Access Programs for new assets.
  • Enable the documentation and communication of regulatory intelligence.
  • Contribute regulatory affairs input for cross-functionally crisis management such as quality alerts, stock-outs and maintain Health Authorities interaction.
  • Review and approve promotional material.
  • Provide relevant support for clinical trials as necessary.

Who you are:

  • Bachelor's degree (or above) in Life Sciences, Pharmacy, or a related field.
  • Proven experience in the regulatory affairs field (RA proficiency) with the UK and EU.
  • Experience in managing regulatory submissions and HA interactions.
  • Proven ability to execute assigned task independently, strong project management skills and a proactive communication approach.
  • Effective time management skills to multi-task several initiatives with demonstrated ability to achieve success.

  • Regulatory Affairs Manager

    5 days ago

    London, Greater London, United Kingdom The businesses of Merck KGaA, Darmstadt, Germany Full time

    Work Your Magic with us  Ready to explore, break barriers, and discover more? We know you've got big plans – so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix...

  • Senior Manager Regulatory Affairs

    1 week ago

    London, Greater London, United Kingdom i-Pharm Consulting Full time £60,000 - £100,000 per year

    Are you passionate about shaping regulatory strategy for life-changing therapies?Do you thrive in a fast-paced environment where your expertise drives global health outcomes?Are you ready to lead complex regulatory submissions and influence cross-functional teams?If your answer isyes, this opportunity could be perfect for you.Position: Senior Manager, Global...

  • Global Regulatory Affairs Manager

    1 week ago

    London, Greater London, United Kingdom Novartis Full time £100,000 - £120,000 per year

    Job Description Summary#LI-Hybrid (12 days per month on-site)Location: London (The Westworks), United KingdomInternal Job Title: Global Program Regulatory ManagerWe are looking for an experienced and proactive Regulatory Affairs Manager to join our Global Regulatory Affairs team. This role is critical in driving regulatory strategy and managing operational...

  • Regulatory Risk Affairs Manager

    2 weeks ago

    London, Greater London, United Kingdom PIC Full time £60,000 - £100,000 per year

    Role purposeThe role is in the Regulatory Affairs team, which sits in the Risk and Compliance function.The role of the team is to facilitate strong regulatory risk management and ensure a good understanding of regulatory risks, issues and projects across PIC. The team assist the business in ensuring that regulatory risks and issues are considered as part of...

  • Regulatory Risk Affairs Manager

    2 weeks ago

    London, Greater London, United Kingdom Pension Insurance Corporation plc Full time £60,000 - £100,000 per year

    Role purposeThe role is in the Regulatory Affairs team, which sits in the Risk and Compliance function.The role of the team is to facilitate strong regulatory risk management and ensure a good understanding of regulatory risks, issues and projects across PIC.The team assist the business in ensuring that regulatory risks and issues are considered as part of...

  • Senior Regulatory Affairs Manager

    5 days ago

    London, Greater London, United Kingdom WEP Clinical Full time £60,000 - £120,000 per year

    Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring ideas that make a real difference. Be part of a...

  • Senior Regulatory Affairs Manager

    5 days ago

    London, Greater London, United Kingdom WEP Clinical Full time £60,000 - £120,000 per year

    Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring ideas that make a real difference. Be part of a...

  • Senior Director, Regulatory Affairs

    4 days ago

    London, Greater London, United Kingdom Beacon Therapeutics (USA) Inc Full time £150,000 - £200,000 per year

    Join Beacon Therapeutics (USA) Inc. as a Full-Time Senior Director of Regulatory Affairs and be at the forefront of transformative biotech innovations. This is a unique opportunity to shape regulatory strategies that directly influence the success of groundbreaking therapeutics in the UK market. Here, you will have the chance to leverage your expertise in a...

  • Senior Director, Regulatory Affairs

    3 days ago

    London, Greater London, United Kingdom Beacon Therapeutics Full time £120,000 - £200,000 per year

    Join Beacon Therapeutics (USA) Inc. as a Full-Time Senior Director of Regulatory Affairs and be at the forefront of transformative biotech innovations. This is a unique opportunity to shape regulatory strategies that directly influence the success of groundbreaking therapeutics in the UK market. Here, you will have the chance to leverage your expertise in a...

  • Global Regulatory Affairs Manager

    4 days ago

    London, Greater London, United Kingdom Novartis Full time £60,000 - £120,000 per year

    SummaryLI-Hybrid (12 days per month on-site)Location: London (The Westworks), United KingdomInternal Job Title: Global Program Regulatory Manager We are looking for an experienced and proactive Regulatory Affairs Manager to join our Global Regulatory Affairs team. This role is critical in driving regulatory strategy and managing operational activities...