Senior Global Program Regulatory Manager

Senior Global Program Regulatory Manager
200+ projects in development. 20 major approvals. 20 major submissions. And that’s just in 2018. This is your chance to help reimagine medicine in 2019. Novartis is looking for dedicated individuals to join our Global Regulatory Affairs team and contribute to developing our superlative pipeline of drugs and biologics into innovative therapies for our patients worldwide. And it all starts with you. Your interest, your talent, your initiative. Take the first step by looking at our track record of amazing accomplishments on behalf of our patients. Novartis employees have enjoyed long, rewarding careers working with colleagues around the world via flexible, family friendly arrangements. Read on for details about the role and how you can join a world-class organization at the forefront of the industry and how you can further your career.

An opportunity to impact the lives of patients worldwide as the new Sr. Global Program Regulatory Manager based at Novartis in Basel. As part of the Global Drug Development (GDD) team, this role is critical in ensuring strategic support and operational regulatory direction for several key programs through development, registration and approval/post approval.

Your responsibilities include, but not limited to:

• Implementing regulatory strategy and managing operational activities for the US and assigned regions, including serving as local HA liaison to FDA.
• Providing input into global regulatory strategy and contributing to the regulatory planning documents, including identification of gaps or risks in global strategic plan for assigned regions.
• Working with the global regulatory lead to plan and facilitate presentations to Novartis boards on regulatory strategy.
• Setting objectives for Health Authority (HA) interactions, facilitating preparation, driving briefing book development, and interacting directly with HAs in meeting in collaboration with the global regulatory lead.
• Developing and implementing plans for timely response to HA requests and driving response preparation.
• Reviewing promotional and non-promotional materials and press releases ensuring messages are consistent with Novartis policies and guidelines.

• Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred.
• Experience with regulatory submission and approval processes including INDs and NDAs/BLAs in the US including HA negotiations (further regional experience an asset).
• Experience in a global/matrix environment or cross- functional teams in the pharmaceutical industry.
• 4-6 years involvement in regulatory and drug/biologic development including post-marketing / brand optimization and commercial awareness.
• Strong interpersonal, communication, negotiation and problem solving skills and basic organizational awareness.

Why consider Novartis?:
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.
We are Novartis. Join us and help us reimagine medicine.
Global Drug Development
Novartis Pharma AG
Research & Development
Full Time