Seeking a CMC Specialist to support CMC Regulatory Affairs activities for small molecule and biological products in Japan.
Roles/Responsibilities
- Assess change controls and develop submission strategies for assigned products.
- Author CMC sections for Japan's PMDA submissions, including partial change applications and minor change notifications.
- Prepare responses to regulatory queries and ensure timely compliance.
- Provide operational support for GMP inspection packages, including NDA, PCA, and Foreign Manufacturer Accreditation.
- Liaise with clients and external partners to maintain regulatory compliance.
- Collaborate with CMC strategists and cross-functional teams to support regulatory submissions.
Required skills
- 4-5 years of experience in CMC Regulatory Affairs, specifically in the pharmaceutical or biotechnology industry.
- Understanding of Japanese and international pharmaceutical regulations, particularly PMDA requirements.
- Experience with Japan's PMDA submissions, including authoring CMC sections.
- Proficiency in Japanese and basic English
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.
