Seeking a highly experienced Senior CMC Specialist to lead CMC Regulatory Affairs activities for small molecule and biological products in Japan
Roles/Responsibilities
- Develop and implement CMC and GMP regulatory strategies for assigned products.
- Lead CMC-related interactions with Japan's PMDA, including authoring and reviewing CMC sections for J-NDA submissions.
- Prepare and review high-quality variation packages, including partial change applications, minor change notifications, and responses to regulatory queries.
- Support GMP inspection packages for NDA, PCA, and Foreign Manufacturer Accreditation.
- Act as CMC Product Lead, ensuring regulatory milestones are met.
- Coordinate with manufacturing, quality, and product assurance teams to ensure regulatory compliance.
- Manage and mentor a team of 2-4 regulatory professionals.
Required skills
- 10+ years of experience in CMC Regulatory Affairs within the pharmaceutical or biotechnology industry.
- Expertise in Japanese and international pharmaceutical regulations, particularly PMDA requirements.
- Proficient in Japanese and basic English proficiency.
Preferred skills
- Regulatory expertise in CMC and GMP compliance.
- Strategic leadership in managing regulatory submissions and health authority interactions.
- Strong communication and stakeholder management skills.
About our client
A global leader in providing comprehensive regulatory solutions and services to the life sciences industry. Helping pharmaceutical, biotech, and medical device companies navigate the complex regulatory landscape, ensuring compliance and accelerating time-to-market for their products.
