This role demands an individual with a robust science or medical degree background, extensive experience in regulatory affairs, and a proven track record of interactions with regulatory authorities, particularly for scientific advice and clinical trial approvals (with emphasis on the US FDA and EMA).
- Provide strategic oversight for all regulatory affairs, including vendor management and deliverable oversight.
- Ensure delivery of key regulatory documents and contribute to the development of clinical plans and strategies.
- Keep abreast of new regulatory guidelines, particularly from the US FDA and EMA, informing management of trends and strategic opportunities.
- Manage resources, budget, and timelines effectively while maintaining compliance with SOPs, ICH/GCP guidelines, and regulatory requirements.
- Oversee the development and maintenance of essential regulatory documents, pharmacovigilance oversight, and CMC document assembly.
- Manage and mentor a team of regulatory professionals, fostering talent development.
- Contribute to the continuous improvement of company processes, interfaces, and SOPs.
- Advanced degree in science or medicine.
- Proven experience in regulatory affairs, with direct interactions with regulatory authorities such as EMA and US FDA.
- Strategic planning expertise for development programs and adept at crafting regulatory strategies.
- Proficiency in US FDA submissions and guideline development.
- Demonstrated leadership in managing regulatory teams within the biotech/pharmaceutical industry.
- A dynamic working environment with opportunities for personal and professional growth.
- A dedicated and supportive team..
- The chance to work on exciting and challenging projects.
- Hybrid working situation possible for the right candidate, but regular presence in Munich office required.