Planet Pharma
Senior Regulatory Affairs -CMC Specialist
Planet Pharma, Alameda, California, United States, 94501
Job Description
Job Title:
Senior Regulatory Affairs - CMC Specialist Department:
Regulatory Affairs Location: Tokyo
Japan Reports to:
Head of Regulatory Affairs, Japan
Employment Type:
Permanent or Contract (Flexible) Compensation:
Competitive, commensurate with experience and seniority
Position Summary The Senior Regulatory Affairs - CMC Specialist will be responsible for leading and supporting Chemistry, Manufacturing, and Controls (CMC) regulatory activities related to product development, registration, and lifecycle management for the Japanese market.
This role combines strategic regulatory insight with technical expertise in analytical sciences and manufacturing. The successful candidate will contribute to CMC dossier preparation, regulatory strategy development, and interactions with Japanese regulatory authorities.
Key Responsibilities
Author, review, and manage CMC sections of regulatory submissions (e.g. J-NDA, partial change, minor change, and post-approval variations).
Evaluate analytical method validation, specification setting, and stability data to ensure scientific soundness and compliance with regulatory expectations.
Develop and execute Japan-specific CMC regulatory strategies aligned with PMDA guidance, ICH guidelines, and global regulatory standards.
Collaborate closely with internal CMC, Quality, and Regulatory teams to ensure submission accuracy and consistency across global filings.
Support and coordinate CMC-related discussions and responses during PMDA consultations and reviews.
Contribute to analytical method transfer, stability studies, and GMP inspection readiness as required.
Maintain an up-to-date understanding of evolving Japanese regulatory requirements (GQP, GMP, validation standards).
Ensure timely submission and documentation of CMC deliverables across development and lifecycle phases.
Support the preparation and review of Quality Overall Summaries (QOS) and maintain clear records of submissions and regulatory communications.
Qualifications and Experience
Bachelor's degree (or higher) in Pharmaceutical Sciences, Analytical Chemistry, Pharmacy, or a related discipline.
Minimum of 5 years' Regulatory Affairs experience, with at least 2 years focused on Japan CMC submissions.
Strong scientific understanding of analytical methods, formulation, and manufacturing processes.
Practical laboratory experience in QC, R&D, or analytical development (e.g. HPLC, GC, dissolution).
Experience with biologics, biosimilars, or sterile injectable products is preferred.
Familiarity with PMDA expectations for analytical validation, specification setting, and stability justification.
Experience collaborating with Contract Manufacturing Organizations (CMOs) or Marketing Authorization Holders (MAHs) in Japan.
Excellent communication skills in English (Japanese language ability desirable).
High attention to detail and strong project management skills.
Ability to manage multiple priorities in a fast-paced, cross-functional environment.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
Job Title:
Senior Regulatory Affairs - CMC Specialist Department:
Regulatory Affairs Location: Tokyo
Japan Reports to:
Head of Regulatory Affairs, Japan
Employment Type:
Permanent or Contract (Flexible) Compensation:
Competitive, commensurate with experience and seniority
Position Summary The Senior Regulatory Affairs - CMC Specialist will be responsible for leading and supporting Chemistry, Manufacturing, and Controls (CMC) regulatory activities related to product development, registration, and lifecycle management for the Japanese market.
This role combines strategic regulatory insight with technical expertise in analytical sciences and manufacturing. The successful candidate will contribute to CMC dossier preparation, regulatory strategy development, and interactions with Japanese regulatory authorities.
Key Responsibilities
Author, review, and manage CMC sections of regulatory submissions (e.g. J-NDA, partial change, minor change, and post-approval variations).
Evaluate analytical method validation, specification setting, and stability data to ensure scientific soundness and compliance with regulatory expectations.
Develop and execute Japan-specific CMC regulatory strategies aligned with PMDA guidance, ICH guidelines, and global regulatory standards.
Collaborate closely with internal CMC, Quality, and Regulatory teams to ensure submission accuracy and consistency across global filings.
Support and coordinate CMC-related discussions and responses during PMDA consultations and reviews.
Contribute to analytical method transfer, stability studies, and GMP inspection readiness as required.
Maintain an up-to-date understanding of evolving Japanese regulatory requirements (GQP, GMP, validation standards).
Ensure timely submission and documentation of CMC deliverables across development and lifecycle phases.
Support the preparation and review of Quality Overall Summaries (QOS) and maintain clear records of submissions and regulatory communications.
Qualifications and Experience
Bachelor's degree (or higher) in Pharmaceutical Sciences, Analytical Chemistry, Pharmacy, or a related discipline.
Minimum of 5 years' Regulatory Affairs experience, with at least 2 years focused on Japan CMC submissions.
Strong scientific understanding of analytical methods, formulation, and manufacturing processes.
Practical laboratory experience in QC, R&D, or analytical development (e.g. HPLC, GC, dissolution).
Experience with biologics, biosimilars, or sterile injectable products is preferred.
Familiarity with PMDA expectations for analytical validation, specification setting, and stability justification.
Experience collaborating with Contract Manufacturing Organizations (CMOs) or Marketing Authorization Holders (MAHs) in Japan.
Excellent communication skills in English (Japanese language ability desirable).
High attention to detail and strong project management skills.
Ability to manage multiple priorities in a fast-paced, cross-functional environment.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.