Assoc. Dir. Regulatory Affairs
Date: Mar 21, 2025
Location: Ebisu, Japan, 150-6018
Company: Teva Pharmaceuticals
Job Id: 60765
Who we are
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.
The opportunity
The Associate Director of Innovative Medicines Regulatory Affairs in Japan will lead regulatory activities for Teva’s innovative products. This role requires a strong understanding of local regulatory requirements and proven experience in leading regulatory submissions, such as Clinical Trial Notifications (CTN), PMDA consultations, and J-NDA dossier preparations. You will be responsible for building and executing regulatory strategies to expedite product registrations and ensuring effective communication with Health Authorities (HAs) and internal stakeholders.
How you’ll spend your day
Develop and implement regulatory strategies for innovative products in Japan, ensuring alignment with global strategies and coordination with internal teams.
Lead and coordinate the preparation, submission, and communication of regulatory documents such as Briefing Packages, CTNs, and J-NDAs.
Establish strong relationships with regulatory authorities (e.g., MHLW, PMDA) and facilitate communication to resolve regulatory issues.
Ensure compliance with regulatory requirements and timelines for successful product submissions.
Represent Japan’s regulatory affairs interests in global teams and contribute to the strategic direction of projects.
Assess business development opportunities from a regulatory perspective.
Your experience and qualifications
Required: BSc/MSc in chemistry, biology, biotechnology, pharmacy, or a similar scientific field.
At least 5 years of experience in regulatory affairs, with a focus on pharmaceuticals or biologics.
Experience interacting with HAs in Japan, including consultation meetings and J-NDA submissions.
Strong knowledge of the regulatory environment, clinical trials, and J-NDA filing processes in Japan.
Demonstrated leadership, project management, and communication skills.
Proficiency in English (spoken and written) at a business level.
Make a difference with Teva Pharmaceuticals
Please submit your CV and a Cover Letter. Only shortlisted candidates will be contacted.
Reports To: Head of Innovative Medicines Regulatory Affairs in Japan
Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. We are committed to a diverse and inclusive workplace for all.
Internal applicants: Apply using the internal career site on Employee Central for priority processing.
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