Regulatory Affairs Manager

Regulatory Affairs Manager – Drive Innovation and Make an Impact Join a global leader committed to serving patients and transforming lives as a Regulatory Affairs Manager. In this pivotal role, you will oversee vital regulatory processes to support clinical trials and the launch of innovative medicinal products across Europe, making a tangible difference for millions of patients worldwide. If you thrive in a collaborative environment and are passionate about shaping the future of biopharmaceutical development, this is your opportunity to excel.

What You Will Do

• Manage regulatory submissions including clinical trial and marketing applications, ensuring compliance with global and local requirements.
• Implement and execute regional regulatory strategies, providing guidance on document preparation, meetings, and approval processes.
• Support product development by advising on regulatory mechanisms such as Fast Track, Orphan Drug, and compassionate use programs.
• Lead label negotiations and contribute to regional product strategies under supervision.
• Perform regulatory research to stay ahead of legislative changes, assessing impacts on product development.
• Collaborate with the European General Medicine Regulatory team, supporting a diverse portfolio in metabolic, cardiology, inflammation, endocrine, and bone disease areas.

Required Skills

• Scientific degree with proven experience in regulatory affairs or a similar role.
• Sound knowledge of legislation, policies, SOPs, and regulations related to medicinal products.
• Familiarity with registration procedures for clinical trials, marketing authorizations, post-approval changes, and renewals.
• Strong understanding of drug development processes and regional regulatory environments.
• Excellent communication skills—both verbal and written—with the ability to articulate complex scientific and clinical information.
• Proactive problem-solving skills and the ability to anticipate issues and develop strategic solutions.

Nice To Have Skills

• Experience with biosimilars or advanced therapy medicinal products.
• Knowledge of European and global regulatory agencies’ processes.
• Fluency in additional languages.

Preferred Education And Experience

• Advanced degree in a relevant scientific discipline.
• Several years of experience in pharmaceutical or biotech regulatory affairs within a European context.

Other Requirements

• Ability to adapt to evolving regulatory landscapes and maintain awareness of new legislation and policies.
• No travel obligations beyond occasional team meetings.

Embrace an opportunity to be part of something bigger—apply today to join a dynamic team dedicated to innovation and excellence in healthcare. Your expertise can help shape the future of medicine and improve lives around the world.