BioTalent are proud to be partnered with a highly innovative biopharmaceutical company with a focus on the development of unique compounds for the
treatment of patients with chronic pain.

As Team Lead Regulatory Affairs & Drug Development, you will be responsible for all regulatory activities related to the design of clinical studies, and applications for new drug marketing authorisations. This is your chance to actively contribute to bringing the first innovation in pain therapy in more than 30 years to the market.

Responsibilities:

• Responsible for developing  regulatory strategy to achieve regulatory objectives in line with the company's goals.
• Responsible for design of clinical trials, alongside the clinical team.
• Coordinate the preparation, submission and follow-up of study and marketing authorisation applications in the EU and the US, including medical writing and ensuring compliance with all relevant laws and regulations.
• Responsible for the leadership and development of the Regulatory Affairs and Drug Development team.
• Manage the collaboration with the external service providers involved in the study

Successful candidates should have a university degree in natural sciences, several years of regulatory drug development experience, and a positive mindset with a can-do attitude.