摘要
About the Role
Key Responsibilities
- Lead and manage mid- to small-scale global regulatory submission projects, ensuring timely and compliant delivery
- Provide strategic input and regulatory intelligence to support global product development, registration, and lifecycle management
- Collaborate with cross-functional teams to implement and optimize global systems, tools, and processes for regulatory operations
- Ensure documentation complies with internal standards and external regulatory requirements, including formatting and retention policies
- Coordinate the preparation, review, and assembly of high-quality regulatory dossiers and submission components
- Analyze and interpret regulatory data, preparing executive summaries and abstracts to support decision-making
- Build and maintain strong relationships with internal stakeholders and external partners to align regulatory strategies
Essential Requirements
- Bachelor’s degree in life sciences, pharmacy, or a related scientific discipline
- Minimum 3 years of experience in regulatory affairs or related pharmaceutical industry role
- Proven ability to manage regulatory submissions and documentation in compliance with global standards
- Strong understanding of regulatory guidelines and documentation systems
- Experience working in cross-functional and multicultural teams
- Excellent written and verbal communication skills in English
- Strong analytical skills with the ability to interpret complex data and summarize key insights
- Proficiency in documentation tools and electronic records management systems
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
Ajustes de accesibilidad
Novartis tiene el compromiso de trabajar y proporcionar adaptaciones razonables para personas con discapacidad. Si, debido a una condición médica o discapacidad, necesita una adaptación razonable para cualquier parte del proceso de contratación, o para des empeñar las funciones esenciales de un puesto, envíe un correo electrónico a [email protected] y permítanos conocer la naturaleza de su solicitud y su información de contacto. Incluya el número de posición en su mensaje.
