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Responsible for leading the team and encouraging changes and challenges, influencing stakeholders inside and outside the company, contributing to the achievement of organizational goals, enhancing performance and productivity, and fostering talent development regardless of whether there are direct reports.

• 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 (scope: new drug application, partial change application for new indication and/or new dosage and administration with clinical trial, new formulation regardless of clinical trial),

• 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.

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

・Native level of Japanese, TOEIC 800 score or above in English.

Required English skills such as the ability to accurately understand and use technical terms related to drug development and regulations, create the specialized regulatory documents, advanced listening and speaking skills to effectively communicate in international meetings, expressing opinions, negotiations and discussions with Global stakeholders about the complicated issues, reading comprehension to efficiently read and understand English professional documents.

Qualifications

• Knowledge of regulatory, CMC, non-clinical, clinical development, and CTD

Description at the time of external employment

• At least 2 years for Regulatory and at least 5 years for R&D and/or Regulatory field in a pharmaceutical company or equivalent.

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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)

As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.

All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)