Summary
About the Role
Major accountabilities:
Regulatory Strategy & Submissions
With multiple stakeholders, develop, document and communicate high quality global regulatory strategies and HA interactions to achieve business objectives.
Evaluate and communicate potential global regulatory opportunities and risks, developing mitigation strategies
Leverage regional expertise in executing global regulatory strategy, and HA engagement.
Provide strategic regulatory input into analysis and interpretation of scientific data, to key documentation,
Leverage scientifc knowledge and acumen in the analysis, interpretation and communication of data to colleagues. Lead interactions with Regulatory Affairs and Development Unit management and external consultants, for input to regulatory strategies.
Accountable, in conjunction (with regulatory labelling) for maintaining Novartis core product information documents though product life cycle.
Contribute to any BD&L Due Diligence activity
Regulatory Excellence & Compliance
Ensure compliance with global regulatory requirements and adherence to regulatory internal policies and processes, coordinating regulatory compliance activities at a global level.
Provide support as needed for non-project related excellence activities.
People
As an effective matrix leader, provide feedback and mentor team members, line functions and sub- teams. Working with line managers, you will provide opportunities for team member growth and development, leading by example acting as a role model for Novartis values and behaviours.
Your Experience:
Science based bachelor's or master's degree. Advanced degree desirable.
Significant regulatory and pharmaceutical development experience, across Phases I-IV.
A track record of working with HA guidance and feedback, discussion and negotiations; post marketing/ brand optimization strategies and regulatory operations.
Proven leadership success across a broad range of regulatory and pharmaceutical development activities.
Strong interpersonal skills and experience working in a complex, cross functional organization, navigating complexity and leading cross function teams.
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.
