Head of Regulatory Affairs (m/f/x)
Location
Gräfelfing | Germany
Job description
Head of Regulatory Affairs (m/f/x)
Permanent employee, Full-time
· Gräfelfing
Your mission
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.
Your profile
- 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.
Why us?
- 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.
About us
Immunic Therapeutics is a dynamic biotechnology company with a pipeline of selective, orally available immunology therapies for the treatment of chronic inflammatory and autoimmune diseases. Currently, three small molecule product candidates are in various stages of clinical development. For more information, please visit: .
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