メディカル・バイオ - メディカルアフェアーズ

■Summary
Job Purpose: Monitor and communicate regulatory intelligence and policy information to facilitate decision making for compliant and quality global development aligned with business objectives.

■About the Role
・Major 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 egislation/guidelines.
Active participation at internal working groups and team meetings
Active contribution to internal presentations (e.g. GREF, GPN, etc.)

■休日：完全週休二日制, 土, 日, 祝日

■Education
Bachelor's degree or higher

■Languages
Fluency in English as a business language.

■Experience/Professional requirement
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).

■職種未経験者：不可