Manager, Regulatory Affairs
About this opportunity
Job title: Manager, Regulatory Affairs
Location: Tokyo
About the job
Role & Responsibilities
The R&D Regulatory Affairs has responsibility for managing products under development and/or marketed products with new indications.
Develop regulatory strategy for new drug developments, Health Authority meetings and Japan New Drug Submission (J-NDA) and provide regulatory expertise within project/product teams for products under development and/or marketed products.
Prepare Japanese Common Technical Documents (J-CTD) for the regulatory submission and arrange the internal review of J-CTD.
Lead the preparation of Clinical Trial Notification (CTN), Health Authority meetings (e.g. PMDA Consultation Meetings) and major regulatory submission (e.g. J-NDA and J-sNDA) and/or any type of responses document to Health Authority questions with the stakeholders (Non- clinical, clinical, Medical, Pharmacovigilance, CMC etc.)
Ensure maintenance and compliance of regulatory activities for development and marketed products.
Accountable for defining the project strategy and associated timeline, identify the risk and mitigation as the JAPC representative on GRT.
Follow regulatory changes, competitor’s status and assess potential impact on daily activities and project strategy.
Lead Japanese Package Insert Revision activities on Commercial and Medical Division’s request that is covered by PMDA New Drug Review Division.
About you
Knowledge, Skills & Competencies / Language
Knowledge of new drug development and regulatory review for the approval
Ability to think logically
Negotiation skills
Communication skills
Able to make continuous efforts with a focus on results
A person who can work positively on his/her own.
A person who can cooperate effectively with others
Qualifications
At least 2 years for R&D or Regulatory field in a pharmaceutical company or equivalent.
Native level of Japanese, TOEIC 800 score or above in English
Why choose us?
In regulatory affairs, as a regulatory expert, we participate in pharmaceutical project teams to provide advice and support to the team. Through this work, we can learn about regulatory changes and the evolution of the development environment related to drug development, thereby enhancing my expertise.
The essence and appeal of regulatory affairs work lies in engaging in constructive discussions with health authorities regarding drug development plans formulated by project teams, bringing these plans to fruition, and delivering medicines to patients as quickly as possible.
Pursue progress , discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !
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 145 comparable Manager Regulatory Affairs roles across 42 biopharma companies.
Salary context
37 of 145 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 145 comparable roles
+ 17 more countries
Seniority mix
145 of 145 peers have a known seniority level
Therapeutic area mix
22 of 145 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.
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.