Bristol Myers Squibb is seeking a Senior Manager for CMC Regulatory, responsible for providing regulatory guidance and leading cross-functional teams to ensure compliance with global standards. The role requires extensive experience in regulatory submissions and technical knowledge in pharmaceutical development
Job Summary
This role involves leading risk assessment and management planning while providing strategic regulatory advice to cross-functional teams.
The position requires extensive experience in creating CTD documents and managing PMDA consultations for drug approvals in Japan.
Bristol Myers Squibb offers a flexible work environment with competitive benefits designed to support employee goals both at work and in personal life.
Matching Summary
Match Score: 85
Bristol Myers Squibb is seeking a Senior Manager for CMC Regulatory, responsible for providing regulatory guidance and leading cross-functional teams to ensure compliance with global standards. The role requires extensive experience in regulatory submissions and technical knowledge in pharmaceutical development.
Skills & Requirements
Must-have
10+ years regulatory application experience
CTD and JNDA/sJNDA submission expertise
GMP/GCTP inspection support capability
Advanced English communication skills
Strong negotiation and leadership abilities
Nice-to-have
Experience with biologic product applications
Coaching and team development skills
Strategic adaptability in global environments
High ethical standards and compliance awareness
Key Requirements
10+ years of regulatory application practice
Expertise in Japanese Pharmacopoeia and manufacturing processes