About the Role

Hands-on Medical Expert responsible for driving clinical-scientific and regulatory activities across the product lifecycle, with a strong focus on the development of high-quality regulatory documentation, scientific data interpretation and support of global submissions and lifecycle management.

Acts as a cross-functional scientific partner, translating complex clinical data into clear scientific and regulatory strategies, ensuring consistency across development programs and marketed products. Supports regulatory interactions, benefit-risk assessments and evidence-based decision-making in collaboration with Clinical Development, Regulatory Affairs, Pharmacovigilance and other key stakeholders.

Provides medical-scientific oversight of medac’s Managed Access Programs (MAP) and Named Patient Use (NPU) requests, ensuring patient-focused and scientifically robust benefit-risk evaluations.

Key Responsibilities

• Author, review and lead high-quality clinical and regulatory documents (CTD), including Clinical Overviews & Clinical Summaries, Clinical Expert Statements, Risk Management Plans (RMPs), SmPCs, CCDS, PILs, PSURs/DSURs and other lifecycle management documents
• Support global regulatory submissions, variations, renewals and post-approval activities
• Interpret and integrate clinical, safety and scientific data into robust regulatory and medical-scientific positions
• Contribute to regulatory strategy documents, briefing packages and support interactions with Health Authorities, including scientific advice procedures and regulatory meetings
• Ensure scientific consistency, quality and compliance across submission and lifecycle documentation
• Collaborate cross-functionally with Clinical Development, Regulatory Affairs, Pharmacovigilance and Commercial functions
• Support benefit-risk evaluations and medical-scientific assessments across the product portfolio
• Evaluate Managed Access Program (MAP) and Named Patient Use (NPU) requests and provide evidence-based medical recommendations
• Contribute to programs involving innovative therapies, including cell therapies and ATMPs

Your Profile

• Advanced degree in Medicine, Pharmacy, Pharmaceutical Sciences, Life Sciences, Biomedical Sciences, Immunology or a related medical-scientific discipline
• Several years of experience in Clinical Development, Clinical Science, Medical Affairs, Regulatory Affairs or a comparable role within the pharmaceutical industry
• Solid understanding of global drug development, regulatory requirements and lifecycle management
• Demonstrated experience in regulatory submission activities, including CTD authoring and Module 2 documentation
• Experience in cell therapies, Managed Access Programs/ Named Patient Use
• Strong scientific writing and communication skills
• Strong analytical thinking and benefit-risk assessment capabilities
• Ability to translate complex scientific information into clear and actionable recommendations
• Fluent in English, some German preferred

Our employees are our greatest asset. And to show our appreciation, we offer attractive benefits:

• Your work-life balance is important to us. We offer flexible working hours with the option of working a proportion of those hours remotely, 30 annual vacation days and an excellent cafeteria
• Attractive salaries and success-based bonuses for all medac employees
• Individual training opportunities: Our medac academy offers a wide range of programmes including leadership training, coaching essentials and language classes
• A funded pension scheme and other social benefits
• We care for our employees beyond the workplace and provide advice on caring for elderly relatives as well as offering counselling
• We promote sports and activities to improve our employees’ health