Description

Job description:

• Develop and implement regulatory strategies for assigned biosimilar products
• Coordinate and prepare regulatory submissions and documentation together with affiliate RA teams
• Support regional labelling updates and maintain risk minimization measures (aRMMs)
• Oversee registration and launch timelines, ensuring timely approvals and implementation
• Communicate effectively with internal stakeholders and external partners, including vendors and regulatory authorities
• Maintain up-to-date awareness of relevant regional regulatory legislation and standards
• Ensure compliance with internal policies, procedures, and regional requirements
• Provide guidance and training to affiliate Regulatory Affairs colleagues where applicable

About the customer:

In this role, you will lead regional regulatory activities for biosimilar products beyond centralized authorization. You will work closely with affiliate Regulatory Affairs teams to ensure national regulatory requirements are met, enabling timely product launches and lifecycle updates across multiple countries. Your contribution will ensure regulatory compliance while supporting efficient and aligned execution of regulatory processes.

Competences:

• Bachelor's degree in pharmacy, chemistry, biology, pharmacology, or another related life sciences discipline
• 3-5 years of experience in the pharmaceutical or biotechnology industry or scientific research
• Minimum of 1 year experience in Regulatory Affairs
• Experience working across multiple regions or markets is considered an advantage
• Strong organisational and communication skills, with the ability to manage multiple workstreams
• Collaborative mindset, able to work closely with internal and external stakeholders