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 legislation/guidelines.

Active participation at internal working groups and team meetings

Active contribution to internal presentations (e.g. GREF, GPN, etc.)

Education / Language / Experience /

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

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

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).

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? http://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally:   http://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf

Accessibility and Accommodation:

Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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