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
Freyr Solutions, established in 2011 in New Jersey, USA, is a global solutions company specializing in pharmaceuticals, medical devices, generic drugs, food, supplements, and cosmetics. The company offers services such as regulatory submissions, product registrations, labeling, artwork, post-approval change management, and regulatory software development. With a presence in 17 countries, Freyr serves over 1,200 clients worldwide and employs more than 1,800 people globally.
