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

[Remote] CMC Regulatory ~ Senior Manager to Director

Roles & Responsibilities

  • Expertise in Japan regulatory framework, interpretation of regulations and guidance, and ability to develop submission strategies.
  • Proven experience authoring high-quality variation packages (PCA) and minor change notifications.
  • Experience supporting GMP inspections and PMDA consultations, including NDA/PCA/Periodic submissions and Foreign Manufacturer Accreditation.
  • Strong independent work capability and effective liaison with clients and external partners to ensure regulatory conformance.

Requirements:

  • Assess change controls for assigned products, identify Japan regulatory requirements, evaluate supporting documentation for acceptability and risk, and execute tasks independently per Japan regulations.
  • Author high-quality variation packages for PCA and minor change notifications, and prepare RTQ responses per CMC strategist guidance and current Japan requirements.
  • Provide operational support for authoring GMP inspection packages (PAI for NDA and PCA/Periodic) and PMDA Foreign Manufacturer Accreditation consultations.
  • Liaise with clients and external partners to support compliant change management and maintain regulatory conformance.

Job description

  • Responsible for assessment of change controls, preparation of submission strategies, identifying Japan regulatory requirements, and critically evaluating supporting documentation to assess acceptability and identify potential risks for assigned products and the ability to execute tasks independently in accordance with Japan regulations, guidance and 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)'s 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 


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