[Innovative Medicine] R&D, Director, Japan Regulatory Policy Leader

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Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 https://www.jnj.com

Job Function:
Communications & Corporate/External Affairs

Job Sub Function:
Government Affairs & Policy

Job Category:
People Leader

All Job Posting Locations:
Chiyoda, Tokyo, Japan

Job Description:

Key Responsibilities for Japan Policy Role:


* Lead Japan regulatory policy strategy, identify and creating strategies to advance potential changes in the regulatory environment and initiatives that are relevant for J&J pharmaceutical products in Japan, as well as understanding the impact across the Asia-Pacific (AP) region.


* Provide GRPI, GRA, AP and China RA with strategic insights to help with internal understanding of regulatory initiatives, and external engagement to help shape regulatory approaches.


* Partner with China RA and AP RA to align with global and regional regulatory policy priorities.



* Drive policy strategic approaches for Japan RA.


* Integrate global regulatory policy strategies with specific Japan needs.


* Coordinate appropriate Japan participation in Trade Association initiatives, as well as regulatory commenting on new guidance documents and regulatory programs.


* Provide expert guidance and interpretation of key regulatory policy issues affecting Japan, the global landscape and the AP region.

Regulatory Policy Alignment with Global and Regional APAC Roles and Responsibilities:


* Integrate Japan Regulatory Policy priorities and activities with Global and APAC RA regional advocacy approaches.


* Implement effective advocacy strategies for Japan, aligned with global and APAC regional regulatory policy activities as appropriate, generating policy positions and strategic plans.


* Collaborate with internal teams within Japan RA and cross functional partners, aligning as appropriate with AP Regulatory, Government Affairs, Legal, and subject matter experts on advocacy strategies for key regulatory topics.


* Facilitate participation of regulatory affairs and other subject matter experts in trade association committees and professional organizations.


* Coordinate and prepare input for health authority commentaries on regulatory guidance and programs to influence key healthcare initiatives.


* Keep internal stakeholders informed about current regulatory guidelines, procedures, and emerging initiatives.

Regulatory Knowledge Management Related to Regional APAC:


* Partner with GRPI members to share insights on relevant global regulatory policy initiative...