Summary
About the Role
Major accountabilities:
You will routinely monitor and escalate internally regulatory information (e.g. relevant laws, guidelines etc published on Health Authority (EC/ EMA/ MHRA/ WHO and other international organisations) webpages and databases, public conferences, workshops and press) to facilitate decision making to ensure global development is both compliant and quality aligned with Novartis business objectives.
Collect, communicate and escalate this intelligence and any insights on Novartis products to Regulatory Affairs Drug Unit, Regions and functions.
Communicate, coordinate and consolidate feedback from internal experts on public consultations to draft regulatory guidance
Participate in internal working groups to evaluate the impact of key regulatory requirements on Novartis projects, contributing to product development regulatory strategy as required.
Provide advice to internal colleagues on EMA processes and procedures.
Participate in external working groups e.g. trade associations.
Develop and present training on new and evolving regulations.
Your experience:
Bachelor's or Master's Degree, science based.
Experience in regulatory affairs, and or Medicine/ Biologics development.
Practical experience of EU scientific advice and application/ variation processes.
Strong interpersonal, communication and negotiation skills.
Experience of working in a complex, cross functional environment, within either industry or HA setting.
Fluency in English.
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
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
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
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
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
