Resumen
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.
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
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
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
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.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
