MedTech Associate Director, Biosurgery, Regulatory Affairs

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

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• Regulatory Affairs Group

• Regulatory Affairs

• Professional

Chiyoda, Tokyo, Japan;
Raritan, New Jersey, United States of America

Ethicon Wound Closure & Healing and Biosurgery is seeking a dynamic and experienced Senior Manager or Associate Director to join our Regulatory Affairs team in Japan. This role offers a unique opportunity to play a pivotal part in advancing innovative medical solutions within the Japanese market. The role requires a strategic thinker with a strong background in Japanese pharmaceutical regulatory processes for drugs and biologics.

Strong experience in or an eagerness to expand knowledge in medical devices and container closure systems is highly valued and will be given strong consideration. The successful candidate will demonstrate excellent project management skills, including clear communication of timelines, development of detailed regulatory plans, and successful regulatory submissions in a global and highly matrixed organization.

• Lead and execute robust regulatory strategies and submissions for pharmaceutical products (drugs & biologics) and medical device-related (including container closure or delivery device) in Japan, ensuring compliance with local regulations.
• Author and lead relevant end-to-end submission activities delivering project milestones and maintaining compliance with local regulations.
• Execution and accountability for maintenance of relevant Japanese regulations for the compliance of biologics and combination products.
• Build and maintain strong relationships with critical external partners, including outside companies, regulatory agencies, industry groups, and other key stakeholders, to support regulatory activities and business partnerships.
• Collaborate effectively with the Wound Closure & Healing and Biosurgery global cross-functional teams to align strategies and ensure seamless execution of platform regulatory plans.
• Manage and coordinate regulatory submissions, ensuring clear communication of timelines, milestones, and deliverables. Proactively address potential delays or issues.
• Provide strong leadership and mentorship, fostering a culture of excellence and collaboration.
• Support global business initiatives, providing regulatory insights and guidance specific to the Japanese market.

• Extensive experience in pharmaceutical regulatory affairs within Japan, with a proven track record in successful drug/biologics (NDA) registrations.
• Experience with combination product approvals in Japan.
• Extensive experience Japanese pharmaceutical requirements for clinical trials, labeling, GXP inspections and CMC.
• Working knowledge of Japanese medical device / combination product regulations and requirements.
• Leadership experience at a senior level, demonstrating the ability to manage teams and influence stakeholders across a matrixed organization.
• Strong strategic and operational skills, with the ability to navigate complex regulatory and business environments to create robust regulatory strategies.
• Excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams across geographies.
• Proven project management experience, including communicating timelines and coordinating regulatory submissions for a global business.

• Fluency in Japanese and English is required.
• Strong ability to align local regulatory activities with broader global business strategies, supporting international initiatives and contributing to the company's overall global regulatory approach.
• Bachelor’s degree (or equivalent) is required.…