[Innovative Medicine] R&D, Senior 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:

Provide strategic regulatory leadership through collaboration with Senior Managers, supporting Regulatory Compound Leaders (RCLs) and contributing to cross-compound regulatory excellence.

• Lead and coordinate regulatory activities as a Regulatory Compound Leader (RCL)
• Support and provide strategic advice to RCLs
• Collaborate to support the management of NDA timelines across compounds; contribute to HA meetings by providing regulatory strategy–based advice and sharing relevant insights with RCLs
• Collaborate on early asset evaluation activities

PRINCIPAL RESPONSIBILITIES:

• Collaborate with other Senior Managers to provide strategic support and advice RCLs
• Contribute to HA meetings by providing regulatory intelligence–based advice and sharing relevant insights with RCLs, in collaboration with Senior Managers
• Collaborate with Senior Managers on TA strategy and due diligence of new compounds
• Contribute to the development and enhancement of organization/systems to enable efficient and consistent regulatory activities
• Foster innovative and creative regulatory thinking, contributing to an environment that enables flexible and breakthrough regulatory strategies
• Contribute to talent development initiatives in collaboration with Senior Managers

EDUCATION, EXPERIENCE & SKILL REQUIREMENTS:

• Minimum of bachelor’s degree or equivalent in pharmacy or life-science or health-related discipline
• Minimum of 8 years of overall experience in R&D in pharmaceutical industry (including 2+ years of regulatory experience) or in health authorities OR Masters/PharmD  and 6+ years, PhD and 4+ years
• Demonstrated leadership and contribution to drug development strategies
• Demonstrated ability to handle multiple projects
• Demonstrated organizational skills
• Experience in HAs interactions
• Working knowledge of regulations in Japan
• Excellent verbal and written communications skills in Japanese and English
• Must be able to develop and maintain excellent working relationships, work successfully within a team environment and as an individual contributor.
• Proactive team player, able to take charge and follow-through.  Achievement-oriented with a high degree of flexibility and ability to adapt to a changing regulatory environment.
• Must be able to work flexible hours to accommodate early morning/evening meetings/ teleconferences with different time zones.

＜For Internal Applicants＞

Based on your experience and interview evaluation, the position title and level may vary.

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 Japan’s employee, you are not able to apply for multiple positions at once.

For Employee Referral Program (ERP), please read and understand the details of the “Internal Referral Overview” on the Ask GS and you have made a compliant referral.

 

 

Required Skills:

 

 

Preferred Skills:

Analytical Reasoning, Business Writing, Compliance Risk, Fact-Based Decision Making, Industry Analysis, Legal Support, Mentorship, Organizing, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Strategic Thinking, Technical Credibility