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
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.
