Morunda | Pharmaceutical | Medical Device Recruiting | Japan (JPAC) Asia (APAC)
Pharmaceuticals • Healthcare Insurance • Recruitment
Morunda is a recruitment firm specializing in connecting multinational companies within the pharmaceutical and medical device industries with top talent in Japan and Asia-Pacific. With over 75 years of combined experience, Morunda focuses on placing senior-level professionals and aiding in market entry strategies, ensuring that organizations find the right candidates to drive success in the healthcare sector.
11 - 50 employees
Founded 2011
💊 Pharmaceuticals
⚕️ Healthcare Insurance
🎯 Recruiter
CMC Regulatory Consultant
Job not on LinkedIn
February 19
🗣️🇯🇵 Japanese Required
Morunda | Pharmaceutical | Medical Device Recruiting | Japan (JPAC) Asia (APAC)
Pharmaceuticals • Healthcare Insurance • Recruitment
Morunda is a recruitment firm specializing in connecting multinational companies within the pharmaceutical and medical device industries with top talent in Japan and Asia-Pacific. With over 75 years of combined experience, Morunda focuses on placing senior-level professionals and aiding in market entry strategies, ensuring that organizations find the right candidates to drive success in the healthcare sector.
11 - 50 employees
Founded 2011
💊 Pharmaceuticals
⚕️ Healthcare Insurance
🎯 Recruiter
📋 Description
• Responsible for finalizing the CMC, GMP regulatory strategies for assigned products/portfolio and support company FTEs to execute tasks independently in accordance with Japanese regulations and guidance, and client procedures. • Lead the Change control evaluation, preparation of submission strategies, identifying Japan's regulatory requirements. • Serve as primary liaison with the Regulatory authorities (e.g., MHLW and/or PMDA) and interface on behalf of Freyr to negotiate as needed to support plans for new drug registrations and activities for existing product licenses. • Deliver all regulatory milestones for assigned products across the product lifecycle
🎯 Requirements
• At least 10 years of experience in the CMC regulatory space • Fluency in English and Japanese • Ideally Have high level knowledge and can guide/lead team in preparation of application documents (Application form and CTD), GMP/GCTP inspection (domestic and overseas), Foreign Manufacturer Accreditation, Master File coordination with In-Country Caretaker, Japanese Pharmacopoeia Applicability, Pharmaceutical development, Manufacturing control and quality control (GMP, GCTP and GQP)
🏖️ Benefits
• Remote work and Flexible work style • Potentially transitioning to a Global CMC RA role • Can work beyond 65 years old
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