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.
Joining the oncology development team you will be able to contribute efforts towards the successful development of novel therapies or combination of therapies to fight cancer, achieve health authorities’ approvals and enable patients’ access to new treatment options to improve and extend their lives. Don’t miss this opportunity to reimagine medicine!
Your Responsibilities Include, but are not limited to:
• Provide regulatory leadership to assigned project(s) • Develop high quality and globally aligned regulatory strategies to achieve optimal development objectives and life cycle management plans • Ensure that Regional/CPO input is sought and incorporated into global regulatory strategy • Evaluate and clearly communicate to management regulatory risks/gaps and trade-offs for the overall development plan and develop mitigation/contingency plans for identified risks • Responsible for development and implementation of the global strategic regulatory plan • Leverage regional expertise in executing globally aligned regulatory strategies, and ensure timely sharing of program changes/information to support timely communication to Health Authorities globally • Partner with regions to align on strategy in order to fulfill business objectives • Acquire timely consultation with RA line management and Novartis advisory boards on strategy
What You'll Bring to the role:
• Science based BS or MS with requisite experience and proven capability. Advanced degree (MD, Ph D, PharmD) preferred • Experience with regulatory submission, HA negotiations and approval processes in major regions • Minimum 6-8 years of regulatory and drug/biologic development experience, ideally spanning activities in Phases I-IV in most or all of the following areas: o Innovation in regulatory strategy. o 2-5 years of proven leadership and accomplishment in all aspects of regulatory affairs in a global/matrix environment in the pharmaceutical industry. o Global matrix management experience desirable. o Good management, interpersonal, communication, negotiation and problem solving skills. o Good organizational awareness (e.g., interrelationship of departments, business priorities), including experience working cross functionally and in global teams, and collaborating effectively with external development partners. o Experience in medical device and/or digital device registration is an asset
Why consider Novartis?
799 million. That’s how many lives our products touched in 2019. 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.
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