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Job Description
RESPONSIBILITIES:
- Develop and execute global regulatory strategies for assigned programs
- Collaborate with regional counterparts to compile and align global regulatory strategies
- Create and submit high-quality, compliant regulatory documents within defined timelines
- Manage regulatory submissions and maintain compliance for assigned programs
- Support health authority interactions and meetings related to assigned programs
- Ensure accurate, up-to-date reporting of program status and milestones globally
- Lead and mentor junior staff, enhancing team capabilities
R&D Qualifications & Skills
- Expertise in developing regulatory strategies and a deep understanding of CMC requirements
- Proven ability to negotiate with and influence health authorities
- Strong leadership skills, capable of managing and directing project teams
- Effective at working across functions to align strategies and achieve objectives
- Skilled in managing regulatory submissions and maintaining compliance
- Excellent communication skills, able to clearly convey complex information
- Proficient in mentoring and developing junior staff, enhancing team capabilities
- Capable of identifying and mitigating risks in regulatory strategies and operations