Regulatory Affairs Manager

Job title: Regulatory Affairs Manager

• Location: Prague, Czechia
• Job type: Permanent, Full time
• Flexible working: Hybrid

About the job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our Czech Republic team as Regulatory Affairs Manager and you will be responsible for the registration and maintenance of marketing authorizations for medicinal products of assigned portfolio, by leading the registration, renewal and post-authorization variation processes. You will be also involved in transversal regulatory activities within region in dedicated projects.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main responsibilities:

• Effective performance of registration, renewal and post-authorization variation processes for assigned portfolio in accordance with the applicable regulations.
• Supervise update of local Product Information texts in contact with internal stakeholders and with the local Health Authorities.
• Develop and strengthen relationship with Regulatory Authorities responsible for the authorization of medicinal products.
• Manage transversal projects in cooperation with Global Regulatory Affairs. Build strong external network (HAs, Trade Associations).
• Contribute to implementing of digital projects in collaboration with other regulatory teams. 
• Manage transversal regulatory activities within Central and South MCO to standardize processes ensuring alignment a cross-country teams.
• Effectively works with other global functions (such as Medical, PV, Quality, Supply Chain).
• Analyze legislative changes, participate in developing new guidance and draft legislation, and lead the drafting of internal procedures.
• Supervise updates to product information and packaging, evaluate promotional materials, and provide regulatory support for promotional activities.

About you

Experience:

• Experience within Regulatory Affairs or in similar function in the pharmaceutical industry.
• Experience in managing Health Authorities communications.
• Experience in project management, including planning and executing strategies.
• Pharmaceutical legislation knowledge (EU and local).
• International and cross-cultural experience will be an asset.

Soft and technical skills:

• Decision making
• Good communication skills
• Organizational skills
• Stress resistance

Education: Master’s degree in medicine / pharmacy / biomedical sciences or other relevant life sciences

Languages: Full professional proficiency in English and Czech.

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

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