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About the Role
A senior-level opportunity for an experienced CMC Regulatory professional to lead regulatory strategy across drug development, submission, approval, and lifecycle management. The role offers significant exposure to global teams and direct involvement in PMDA interactions and complex CMC regulatory matters.
Responsibilities
- Develop and execute CMC regulatory strategies across development and lifecycle management
- Lead JNDA/sJNDA submissions, CTD preparation, and PMDA consultations
- Manage regulatory strategy for manufacturing changes, product quality, and post-approval activities
- Support GMP/GCTP inspections, foreign manufacturer accreditation, and Master File activities
- Lead communication, discussion, and negotiation with PMDA
- Provide CMC regulatory expertise and strategic input to cross-functional and global teams
- Assess regulatory risks and develop appropriate mitigation strategies
- Coach and support team members while providing technical and regulatory leadership
Requirements
- 10+ years of CMC Regulatory experience with strong hands-on submission experience
- Experience with JNDA/sJNDA, CTD, partial change applications, and minor change notifications
- Strong knowledge of GMP/GCTP/GQP, Japanese Pharmacopoeia, manufacturing, and quality control
- Experience with GMP/GCTP inspections, foreign manufacturer accreditation, and Master Files
- Strong understanding of pharmaceutical development, formulation, analytical chemistry, biochemistry, and microbiology
- Excellent English communication and negotiation skills with experience working independently with global teams
- Strong leadership and coaching capabilities
- Experience with biologics or regenerative medicine is a plus
Skills
- CMC Regulatory strategy
- JNDA/sJNDA submissions
- CTD preparation
- PMDA consultations
- Manufacturing change management
- Product quality management
- Post-approval activities
- GMP/GCTP inspections
- Foreign manufacturer accreditation
- Master File activities
- Communication
- Negotiation
- Risk assessment
- Mitigation strategies
- Leadership
- Coaching
- Biologics
- Regenerative medicine
Experience Level
- Senior-level
- 10+ years
Benefits
- Strategic leadership role in CMC Regulatory within a global pharmaceutical organization
- Work closely with global development and regulatory teams
- Broad exposure across development, submissions, PMDA engagement, and lifecycle management
- Influence regulatory strategy for complex products and manufacturing changes
- Opportunity to leverage deep CMC expertise while developing leadership and coaching responsibilities
- Work in a fast-moving environment where regulatory strategy directly supports the development and availability of innovative medicines