Regulatory Affairs Manager (m/f/d)

Tasks :

• Defines, develops, and supports regional regulatory strategies (EUCAN or GEM) to maximize regulatory success, support product development, and enable timely patient access through investigational applications, market approvals, and life-cycle management.

• Collaborates closely with global, regional, and local teams to align on program objectives and ensure full compliance with applicable regulatory requirements throughout product development and life-cycle.

• Leads or supports Submission Working Groups and represents the region on global and project teams, coordinating regulatory activities across the product life cycle.

• Maintains up-to-date knowledge of regional regulations and guidance, assessing their impact on drug development, registration, and post-marketing commitments to optimize regulatory outcomes and compliance.

• Provides regulatory expertise for drug development, registration, post-marketing compliance, and life-cycle management, including authoring and reviewing internal procedures and regulatory documents.

• Develops strong working relationships with internal teams, consultants, business partners, and health authorities, supporting effective communication of regulatory strategies, submission plans, and health authority interactions.

• Oversees and actively manages interactions with Health Authorities in EUCAN and GEM regions, preparing for and representing the company in meetings, communicating outcomes, and ensuring timely regulatory submissions and approvals.

Qualification:

• BSc. Advanced scientific related degree preferred; BA accepted based on experience.
• A minimum of 4 years of experience in drug regulatory affairs preferably within the EU/GEM region.
• Experience with advanced therapeutic medical products (Cell & gene therapy) will be advantageous.
• Solid regulatory experience, including knowledge of regulations and guidance governing drugs and biologics in all phases of development for [Emerging markets and/or EUCAN Markets (relevant to role)] as well as leading interaction with Health Authorities.
• Has basic regulatory procedure knowledge with major health authorities in the region
• Analyzes issues with attention to detail and makes reasoned recommendation
• Promotes an inclusive culture and expresses empathy for others
• Is able to carry out assigned activities within reasonable time
• Fluency in English

Start : 15.09.2025