The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
26 major approvals. 13 major submissions. 2,000 associates worldwide. That was Regulatory Affairs in 2020. We are a culturally diverse, global team of talented professionals seeking to leverage the voices of our patients in our approach to bringing potentially life-changing therapies to people who need them. Novartis has a robust pipeline, including possible treatments for rare disease conditionals with unmet needs.
We are expanding our global team and encourage you to consider a career in Regulatory Affairs at Novartis. Working collaboratively and interactively thanks to our technology, we have been as connected as ever—OneRA as we call it. We pride ourselves on our patient-focused mindset and dedication, which allow us to work closely with colleagues, share knowledge, and strive to reimagine medicine. Read on to learn what you could do as part of our closely knit team.
A position in Global Drug Development Regulatory Affairs Operations responsible for handling the delivery of cross functional submission documentation, being responsible for publishing activities and dispatch of compliant, worldwide regulatory submissions in support of Novartis global product portfolios.
Your Responsibilities include, but are not limited to: • Handles multiple and simultaneous global regulatory submission projects in eCTD and non-eCTD format [e.g., NDA/BLA/INDs, MAAs (CP, MRP, Nees), HA AtoQ, Compliance submissions, etc.]
• Drives cross-functional teams focused on the planning, compilation and dispatch of worldwide regulatory submissions, anticipating technical obstacles and developing solutions
• Provides guidance to project teams related to worldwide HA submission structure at/requirements, submission filing strategy, eCTD document lifecycle management and submission compilation workflows
• Tracks timely delivery of submission components, coordinates submission publishing activities with publishing team and coordinates internal review and approvals
• Partners with cross functional groups across the organization and contributes to operational activities and ongoing initiatives
• Effectively troubleshoots technical/quality issues relating to compilation, validation and dispatch of global submission outputs
• Assesses publishing resource and support needs and develops/implements solutions to create efficiencies
What you bring to the role:
• BS in Life Sciences or a relevant discipline with at least 5 years of professional work experience. Masters degree preferred.
• 3-5 years of Regulatory Affairs or Regulatory submission related experience.
• Experience with global regulatory submission formats, including familiarity with submission publishing activities
• Familiarity with the drug development process
• Effective interpersonal skills, strong written and oral communication and presentation skills
• Proven project management, organizational and time management skills to manage multiple ongoing projects simultaneously
• Familiarity with global Health Authority regulations/guidances eg., FDA regulations, ICH and EMA guidelines/directives
• Works independently and with minimal supervision
• Proficiency with computer programs/systems (MS office, etc.) with proven ability to learn new systems quickly
Why consider Novartis?
769 million. That’s how many lives our products touched in 2020. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.