[Innovative Medicine] R&D, Specialist/Manager, Regulatory Strategy & Liaison Group, Regulatory Development, 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 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 humanity. Learn more at jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function
Regulatory Affairs Group
Job Sub Function
Regulatory Affairs
Job Category
Professional
All Job Posting Locations:
Chiyoda, Tokyo, Japan
Job Description
POSITION SUMMARY:
- Lead Japanese regulatory strategy and target labeling in J-CDT, and share the information to the Global Regulatory Team (GRT)
- Lead CTD Preparation Team for J-NDA submission
- Lead Japanese Health Authority (HA) response such as PMDA consultation/ preliminary meeting, MHLW meeting related the development of compound, 30 (14) Day review for J-CTN regarding development plan and submission
- Negotiate with HAs regarding development compound
Principal Responsibilities
Input regulatory strategy to J-PT
- May serve as a regulatory lead at J-PT
- Participates in GRT to provide inputs on Japanese regulatory strategy and target labeling
- Refines Japanese regulatory strategy as new data becomes available and re-assesses as necessary
- Provides input into strategy with respect to clinical study design for local studies. (Provides input into global clinical studies with Japanese requirement if needed)
- Develops and updates contingency plans for regulatory strategies as they pertain to Japan
- Provides input on implications for regulatory strategy through participation in J-PT
- Reviews and provides regulatory input on Japanese Investigator Initiated Proposals as required
- Within the context of the global strategy, determines timing, appropriate Japanese strategy and content for Japanese HA meetings of development products.
- Provides input on study design, conduct, and need for any additional studie...
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