Regulatory Affairs Manager (m/f/d)

Contract start date: As soon as possible

End date: 31.03.2026

Responsibilities:

• Collaborates with Global, Regional counterparts, Local Regulatory Affairs, to manage all aspects of regulatory activities throughout the product life cycle.
• May be regulatory lead or support a more senior regulatory lead for assigned assets and/or projects.
• May present regional regulatory strategies to leadership/senior management
• Stays current with regulations / guidance in the region for impact on drug development plans, registration, and life-cycle management to maximize the positive outcomes of the regulatory applications and maintain regulatory compliance.
• Provides regulatory expertise on drug development, registration and / or post-marketing compliance and life cycle management.
• Monitors the relevant regional regulations /guidance for programs in area of responsibility
  and participates in the review of new legislation and regulatory procedural guidelines, as applicable.
• Participates, as appropriate, and authors/reviews internal procedures and processes.
• Actively pursues the tracking and fulfillment of post marketing commitments.
• Understands and interprets complex scientific issues for products of responsibility as it relates to regulatory requirements and strategy.
• Supports Acce.ss to Medicines initiatives to develop and implement innovative patient access strategies
• Develops effective working relationships with LOC Regulatory Lead, Regional and Global Regulatory Team, Cross- functional Teams; company’s consultants and Business Partners as required.
• Effectively communicates the regulatory strategies, submission plans and timelines, probability of success, and impact assessments of trends, regulations and changes related to assigned programs.
• Accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within area of responsibility
• Understands importance of regulatory documents for value and access discussions and partners with access functions to support access applications as needed
• Leads or supports preparation activities for meetings with Health Authorities for the assigned program, as required.
• Oversees LOC interactions with Health Authorities in Growth & Emerging Markets for responsible programs.
• Interacts directly with HA (EUCAN), as required.
• May represent the company in Health Authority meetings. Effectively communicates and manages meeting outcome and next steps, as required.

Requirements:

• 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.