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 https: //www.jnj.com

Job Function:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job Description:

Johnson & Johnson is seeking a Director, Regulatory Policy Leader APAC to join the APAC Regulatory Affairs team.

Key Responsibilities:

• Lead and manage a team that identifies changes in the regulatory environment and initiatives that are relevant for J& J pharmaceutical products within the Asia-Pacific (AP) region.
• Provide GRPI, GRA, and AP RA with strategic insights to help with internal understanding of regulatory initiatives, and external engagement to help shape regulatory approaches.
• Partner with China and Japan Policy leads and RA to align with global and regional regulatory policy priorities.

• Drive policy strategic approaches for APAC RA.
• Integrate global regulatory policy strategies with specific AP regional needs.
• Coordinate appropriate regional 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 both the global landscape and the AP region.

Regulatory Policy Global and Regional AP Responsibilities:

• Integrate China and Japan Regulatory Policy priorities and activities with APAC RA regional advocacy approaches.
• Implement effective advocacy strategies for global and APAC regional regulatory policy activities, generating policy positions and strategic plans.
• Collaborate with internal teams, including AP Regulatory, Government Affairs, Legal, and subject matter experts, to ensure alignment 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.

Regional AP Leadership:

• Support the goals and objectives of the AP Regional functions.
• Supervise and mentor the regional GRPI staff to achieve desired outcomes.

Regulatory Knowledge Management Regional AP Responsibilities:

• Partner with GRPI members to share insights on relevant global regulatory policy initiatives.
• Ensure that AP-specific issues are effectively included in the Health Authority regulatory commenting processes.

LT Membership:

Actively participate in the GRPI Leadership Team (LT) to develop and meet organizational goals and objectives.

Qualification/Requirements

Required Minimum Education:

• Bachelor’s degree in scientific discipline

Required Knowledge, Skills and Abilities:

• Min. 5 years in pharmaceutical industry
• Min. 2 years in Regulatory Affairs or Policy
• Strong computer skills, ability to work with programs such as Smartsheet

Preferred Knowledge, Skills and Abilities:

• Strong computer skills, including with programs such as Smartsheet;
• 6-10+ years in pharmaceutical industry
• 3-5+ years in Regulatory Affairs or Policy
• Experience at Health Authority
• Solid understand of the global regulatory environment, including in US, EU, and AP.