Manager Reg. Policy & Intelligence

at  Novartis

SUMMARY

Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people’s lives. To do this, we are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic area and platform depth and capabilities – all to bring our medicines to patients even faster. We are seeking key talent, like you, to join us and help give people with disease and their families a brighter future to look forward to. Apply today and welcome to where we thrive together! The Role: This role offers hybrid working, requiring 3 days per week in our White City, London office. As Manager, Regulatory Policy and Intelligence you will monitor and communicate regulatory intelligence and policy information, to facilitate decision making to ensure global development is both compliant and quality aligned with Novartis business objectives.

MAJOR ACCOUNTABILITIES:

• You will routinely identify and escalate internally, relevant regulatory information (e.g. relevant laws, guidelines etc.) to facilitate decision making to ensure global development is both compliant and quality aligned with Novartis business objectives.
• Collect and communicate this intelligence and any insights on Novartis products to Regulatory Affairs Drug Unit, Regions and functions.
• Prepare analysis reports and contribute to internal knowledge management systems, coordinating internal feedback from cross functional teams on draft regulations and guidelines.
• Communicate new and emerging regulatory requirements to RA colleagues and relevant line functions via oral and written communication e.g. newsletters, information e-mails.
• Support internal activities for the development of policy strategies and advocacy plans.

YOUR EXPERIENCE:

• Bachelor’s or Master’s Degree
• Experience in regulatory affairs, and/or Medicine/ Biologics development.
• Good knowledge of EU scientific advice/ variation processes.
• Strong interpersonal, communication and negotiation skills.
• Experience of working in a complex, cross functional environment, within either industry or HA setting.
  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.