Novartis

Job Description 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 join us in reimagining new medicines together!

The Role:

As Global Program Regulatory Director, you will provide global leadership throughout the lifecycle of a development and/or marketed product program(s). Your experience will ensure that input from global HAs, regional and functional collaborators is collated to build a coherent, global regulatory strategy which fulfills the target product profile and portfolio objectives.

You will also be responsible for identifying regulatory opportunities, mitigate against potential issues and ensure the execution of regulatory strategy across regions. In addition, you will lead global regulatory sub- team(s), share your regulatory and development expertise, and represent the RA function on cross functional initiatives and committees.

Job Description

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 scientific 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? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Accessibility & Accommodation : Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to diversity.inclusion_ch@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Skills Desired

Clinical Trials, Cross-Functional Teams, Drug Development, Lifesciences, Negotiation Skills, People Management, Problem Solving Skills, Regulatory Compliance, Risk Management, Strategy Execution