Japan Regulatory Compliance Manager
About this opportunity
Career Category
Regulatory
Job Description
Group Purpose
The Compliance Group is responsible for MAH business license, Three-supervisors’ committee (Sanyaku-kaigi), Foreign Manufacturer Accreditation/ Foreign Manufacturer Registration (FMA/FMR), periodic GMP inspection, and other activities to ensure compliance the Act on Pharmaceutical and Medical Device(PMD) Act. and to support the execution of the pharmaceutical business.
Job Summary
Support the operation of the Three Supervisors’ Committee (Sanyaku-kaigi) including preparation of materials and meeting documentation.
Excuse MAH license management and regulatory compliance activities in accordance with the Pharmaceuticals and Medical Device (PMD) Act.
Carry out FMA/FMR and GMP-related application and maintenance activities.
Prepare regulatory submission materials and support communication with health authorities in coordination with internal functions.
Key Activities
Perform MAH-related tasks: preparation and documentation for the Three Supervisors’ Committee, SOP/document management, inspection readiness, and training support.
Support FMA/FMR acquisition and renewal: application, registration, and communication with MHLW/PMDA.
Contribute to GMP inspection preparation in collaboration with Quality team.
Handle import certificates (Yakkan) via Nippon Automated Cargo and Port Consolidated System (NACCS) and export notifications in a timely manner.
Conduct regulatory review of promotional and non-promotional materials in terms of applicable laws, regulations, and internal policies.
Knowledge and Skills
Practical knowledge of the PMD Act.
Basic communication skills for interactions with health authorities (PMDA, etc.).
English proficiency for document preparation and email communication.
Basic IT skills (business applications, document management systems).
Education & Experience (Basic)
Bachelor’s degree (preferably in a scientific field).
At least 5 years of pharmaceutical industry experience in regulatory-related activities.
Education & Experience (Preferred)
Master’s or Doctoral degree
.
Job details
How this role compares
Computed from every other active Regulatory Affairs role in our database, not just this employer's listings.
We currently track 192 comparable Manager Regulatory Affairs roles across 64 biopharma companies.
Salary context
52 of 192 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 192 comparable roles
+ 27 more countries
Seniority mix
192 of 192 peers have a known seniority level
Therapeutic area mix
16 of 192 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
Notify me about similar jobs
Get an email when we spot other openings like this one – same job function, comparable seniority, roles you'd actually want to see.
How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.