[MedTech] Associate Director, Biosurgery, Regulatory Affairs

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech 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 more at

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Position Overview:
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 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.

Key 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.

Qualifications:

• 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.

Requirements:

• 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 companys overall global regulatory approach.

• Bachelors degree (or equivalent) is required. Advanced degree is a plus. Degree in a technical related discipline is preferred.

• 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.

• Experience working closely with and negotiating with Health Authorities is preferred.

• Experience working with professional and trade associations is a plus.

• The position is preferred to be located in Tokyo Japan or Raritan NJ with 30-50% travel to Japan.

If you are Japan employee please read Internal Application Guideline in Ask GS. Especially if you are less than 18 months in your current role you are required to obtain application approval from your current manager as well as your respective BUHR. If you are Japans employee you are not able to apply for multiple positions at once.
Once you move to 1st interview stage please make sure to inform to your current manager.
For Employee Referral Program (ERP) please read and understand the details of Employee Referral Program in Ask GS and make a compliant referral.

応募の際はAskGS内の社内公募ガイドラインをご一読いただき応募ください１８か月未満の方は応募前に上長及び担当BUHRの許可を取ってから応募ください複数同時応募不可になります
在籍期間に関わらず書類選考を通して１次面接に進んだ場合は社内公募に応募し選考に進むことを上司に報告してください
社内紹介を行う場合はASK GS上のEmployee Referral Programの詳細を理解した上でコンプライアンスを守って紹介したものとみなします

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