Seeking a Certificates Specialist to manage regulatory documentation and certification processes for pharmaceutical products in Japan.
Roles/Responsibilities
- Process Certificates of Pharmaceutical Product (CPP) and GMP compliance inspection applications to PMDA.
- Coordinate with contract manufacturing organizations (CMOs) and internal stakeholders to obtain:
- GMP certificates
- Manufacturing licenses
- Other required regulatory documentation
- Manage documentation requests, including:
- Letters of authorization
- Declarations
- Notarization and legalization processes
- Receive and route certificates via the PSS Certificate tool.
- Prepare performance dashboards and provide periodic updates to stakeholders.
Required skills
- 1-3 years of experience in a pharmaceutical regulatory or documentation role.
- Strong understanding of PMDA and MLHW submission processes and regulations.
- Experience in handling statutory documents and regulatory certifications.
- Proficiency in Japanese and basic English
About our client
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.
