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
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.
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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.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Division
Development
Business Unit
Innovative Medicines
Location
Japan
Site
Head Office (Japan) (Pharmaceuticals)
Company / Legal Entity
JP05 (FCRS = JP005) Novartis Pharma K.K.
Functional Area
Research & Development
Job Type
Full time
Employment Type
Regular
Shift Work
No