Senior Manager – Director, CMC Regulatory

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🕒 January 5

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Morunda | Pharmaceutical | Medical Device Recruiting | Japan (JPAC) Asia (APAC)

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2011

💊 Pharmaceuticals

⚕️ Healthcare Insurance

🎯 Recruiter

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.

📋 Description

• Assessment of change controls • Preparation of submission strategies • Identifying Japan regulatory requirements • Evaluating supporting documentation for acceptability and potential risks • Authoring high-quality variation packages for PCA and minor change notifications • Authoring responses to RTQs based on guidance • Operational support for GMP inspection packages • Liaison with clients and external partners for change management

🎯 Requirements

• Responsible for assessment of change controls • Preparation of submission strategies • Identifying Japan regulatory requirements • Critically evaluating supporting documentation to assess acceptability and identify potential risks for assigned products • Ability to execute tasks independently in accordance with Japan regulations and guidance • Discuss regulatory strategies to perform in-scope activities • Authoring of high-quality variation packages for 'partial change application (PCA)' and minor change notification • Authoring response to RTQ (request to query) based on the guidance from the CMC strategist in line with current Japan requirements • Operational support for Authoring of packages for GMP inspection [PAI for NDA and PCA/Periodic] • Operational support for Authoring of packages for GMP inspection - Foreign Manufacturer Accreditation for PMDA consultation • Liaise with client and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.

🏖️ Benefits

• Work Style: Remote flexibility