Regulatory Affairs Manager

3 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 of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

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.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity

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