Johnson & Johnson MedTech · 22 hours ago
[MedTech] Associate Director, Biosurgery, Regulatory Affairs
Raritan, NJ
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
7+ years expJohnson & Johnson MedTech is a leader in healthcare innovation, dedicated to advancing medical solutions. The Associate Director of Regulatory Affairs will lead regulatory strategies and submissions for pharmaceutical products and medical devices, ensuring compliance with Japanese regulations while collaborating with global teams.
Hospital & Health Care
Responsibilities
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
Qualification
Required
Fluency in Japanese and English is required
Bachelor's degree (or equivalent) is required
Minimum 7 years relevant pharmaceutical/medtech industry experience is required or 5 years with an advanced degree
Previous experience with biologics (including regulatory submissions) is required
Proven track record of developing and executing global regulatory strategies that align with business deliverables is required
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
Preferred
Experience working closely with and negotiating with Health Authorities
Experience working with professional and trade associations
Advanced degree is a plus
Degree in a technical related discipline is preferred
Company
Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Mike Walker
CFO & VP of Finance DePuy Synthes
Tino Schweighoefer, MBA
CFO Monarch Platform
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