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 extraordinaryBetter 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!
Skills Required
- At least 2 years experience in R&D or Regulatory field in a pharmaceutical company or equivalent
- Native level Japanese
- TOEIC 800 score or above in English
- Knowledge of new drug development and regulatory review for approval (Japan/PMDA)
- Experience preparing Japanese Common Technical Documents (J-CTD) and major regulatory submissions
- Ability to think logically
- Negotiation skills
- Strong communication skills
- Ability to work independently and be results-focused
- Ability to cooperate effectively with cross-functional teams
Sanofi Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Sanofi and has not been reviewed or approved by Sanofi.
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Retirement Support — Retirement support stands out through a notably strong 401K matching structure (e.g., 150% match up to a 6% contribution), which materially boosts total rewards for long-tenured employees.
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Parental & Family Support — Parental and family support is positioned as unusually robust, including a global gender-neutral paid parental leave standard (14 weeks) and added supports such as childcare assistance and adoption/surrogacy/infertility help.
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Equity Value & Accessibility — Equity participation is made more accessible via an Employee Stock Purchase Plan that includes a meaningful purchase discount and matching/free-share mechanics, increasing perceived total compensation beyond base pay.
Sanofi Insights
What We Do
We are Sanofi, an innovative global healthcare company. We chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Interactions with this account must comply with the Terms: https://bit.ly/sanofi-terms
