Department
Health & Biotech
Category
Health & Biotech
Job type
Full-Time
Experience
Not Mentioned
Description
- Leading the development of global regulatory strategies for clinical programmes, including plans for key health authority interactions and milestones.
- Authoring and reviewing complex regulatory documents such as clinical trial applications, briefing books, and major submission components.
- Interpreting evolving global regulations, guidelines, and precedents, and advising teams on implications for programme design and execution.
- Providing strategic input into clinical development plans, risk management strategies, and labelling considerations.
- Representing regulatory functions in sponsor and health authority meetings, ensuring clear, scientifically robust communication.
- Mentoring junior regulatory colleagues and contributing to internal best practices, templates, and knowledge-sharing initiatives.
Qualifications
Highest qualification: University
- Bachelor's degree in a relevant scientific discipline or healthcare-related field
- Extensive experience in regulatory affairs or regulatory science within pharma, biotech, or CRO environments.
- Strong knowledge of global clinical development regulations (e.g., FDA, EMA, ICH) and regional requirements.
- Excellent scientific, analytical, and critical-thinking skills, with the ability to integrate complex data into regulatory positions.
- Outstanding written and verbal communication abilities, with meticulous attention to detail.
- Proven experience interacting with health authorities and leading cross-functional regulatory projects.