仕事内容
At Regeneron, we are driven by innovation and a commitment to improving lives. As part of our global expansion, we are seeking a dedicated Regulatory Affairs Manager to join our growing regulatory team in Japan. This role offers a unique opportunity to shape the regulatory landscape for biological products and regenerative medicines in Japan, while collaborating with a diverse team of experts locally and globally. If you’re passionate about navigating regulatory processes and making a meaningful impact, we’d love to hear from you.
A Typical Day:
Lead the preparation, submission, and maintenance of clinical trial applications to PMDA.
Coordinate and execute health authority meetings, including PMDA consultations and MHLW meetings.
Manage timely submissions of marketing authorization applications and post-approval changes for assigned projects.
Ensure compliance with Japan’s regulatory requirements and local standards.
Collaborate with cross-functional teams, including clinical, commercial, medical, and patient safety colleagues.
Assist in the development of local labeling and patient information for key programs.
Support the regulatory review of promotional materials as needed.
This Role May Be For You If:
You have a Bachelor’s degree in a scientific discipline, with a Master’s degree in Science or Pharmacy being preferred.
You bring approximately 5 years of experience in regulatory affairs, particularly with J-NDA submissions and approvals in Japan.
You take pride in your ability to prepare and review documents like J-CTDs and briefing materials for PMDA consultations.
You are eager to learn about regulatory strategies and drug development across multiple products.
You have a strategic mindset, strong commercial awareness, and excellent communication skills in English.
You thrive in a global, matrixed team environment and enjoy fostering collaboration.
You are familiar with advising on regulatory requirements for clinical trials (advantageous but not mandatory).
To Be Considered:
To excel in this role, you must have a Bachelor’s degree in a relevant scientific field and approximately 5 years of regulatory experience, including expertise in J-NDA submissions and document preparation for PMDA consultations. Candidates with a Master’s degree in Science or Pharmacy and experience advising on clinical trial requirements will be highly regarded. Strong communication skills in English and the ability to work effectively in a global team are essential.
Join us in shaping the future of medicine and making a difference in patients' lives. Apply now to become a part of our inspiring journey.
本ポジションにご興味をお持ちいただけましたでしょうか。みなさまのご応募を心よりお待ち申し上げております。我々の企業理念であるRegeneron Wayを共に歩む、その第一歩を踏み出しましょう。当社では、多様性を大切にする企業文化に基づき、幅広い内容の福利厚生をご用意しております（内容は地域によって異なります）。米国の場合、ヘルス＆ウェルネスプログラム（医療保険、歯科治療や眼科治療に関する保険、生命保険および身体障がいに関する保険など）、フィットネスセンター、確定拠出年金（401k）、家族支援制度、株式報酬、年次ボーナス、有給休暇、および特別有給休暇制度（例：育児休暇、軍務休職）などがあり、対象となる社員の方であれば、すべての職位においてご利用いただけます。当社の、米国における福利厚生の詳細に関しましては、https://careers.regeneron.com/en/working-at-regeneron/total-rewards/をご参照ください。その他の国における福利厚生に関しましては、採用担当者までお問い合わせください。
最高の仕事を通じて最もすばらしい成功を手にするためには、社員が一丸となって働くことこそ重要である、という信念に則り、当社では多くの職種において、オフィス勤務を必須とさせていただいております。オフィス勤務に関する当社のポリシー、および勤務内容や勤務地に関するみなさまお一人おひとりの個別の条件につきましては、採用担当者にお問い合わせください。