Manager, Reg&Dev Policy Japan​

EMajor accountabilities:

• Monitor and search relevant laws, guidelines and other regulatory information published on Health Authority webpages and databases, public conferences, workshops and press.
• Collect and communicate intelligence, learning from Scientific Advice and/or other health authority advisory boards (e.g., FDA Advisory Committees) for our products to RA DUs, Regions and Functions as appropriate.
• Contribute to internal knowledge management systems and produce analyses reports.
• Prepare and coordinate internal Novartis feedback from cross-functional teams on draft regulations and guidelines
• Communicate new and emerging regulatory requirements to RA colleagues and relevant line functions via written communication, such as newsletters, information e-mails.
• Support internal activities for the development of policy strategies and advocacy plans.
• Make presentations, as appropriate, as a means to communicate new or evolving regulatory requirements.

Key performance indicators:

• Proactive communication of new and evolving regulatory requirements.
• Timely coordination and follow-up of Novartis feedback to draft legislation/guidelines.
• Active participation at internal working groups and team meetings
• Active contribution to internal presentations (e.g. GREF, GPN, etc.)

Minimum Requirements:
Work Experience:

• 2-4 years involvement in regulatory and/or drug/biologic development.
• Experience in a global/matrix environment or cross-functional teams in the pharmaceutical industry or health authority.
• Strong interpersonal, communication, negotiation and problem-solving skills.
• Basic organizational awareness (e.g., interrelationship of departments, business priorities).

Languages :

• Fluency in English as a business language. Additional language(s) beneficial.

Education:

• Education: Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) desirable.