Manager Global CMC Regulatory Affairs

Overview

We are seeking an experienced Regulatory Affairs Manager to join our Global Regulatory Affairs team, supporting the development of small molecule drug products across clinical development phases I–III. This role will play a key part in shaping and executing global regulatory strategies to enable efficient clinical development and timely progression of assets.

Key Responsibilities

• Develop and implement global regulatory strategies for small molecule products across Phases I–III
• Lead regulatory activities for clinical development programs, including IND/CTA submissions, amendments, and lifecycle management
• Act as the regulatory lead on cross-functional development teams, providing strategic guidance to R&D, Clinical, CMC, and Quality functions
• Prepare, review, and manage high-quality regulatory documentation (e.g., briefing documents, investigator brochures, clinical trial applications)
• Interface with global health authorities (e.g., EMA, FDA, other regional agencies) and support regulatory meetings and interactions
• Monitor and interpret evolving global regulatory requirements and assess impact on development programs
• Support regulatory intelligence activities and contribute to risk assessment and mitigation strategies
• Ensure compliance with applicable regulatory guidelines, internal procedures, and timelines

Qualifications & Experience

• University degree in Life Sciences, Pharmacy, Chemistry, or a related field (advanced degree preferred)
• 5+ years of experience in Regulatory Affairs within the pharmaceutical or biotech industry
• Strong experience with small molecule drug development
• Proven hands-on experience supporting clinical development Phases I–III
• Solid knowledge of EU and global regulatory frameworks
• Experience working in global, cross-functional teams
• Strong project management, communication, and stakeholder-management skills
• Fluency in English (German is an advantage but not required)