Global Program Regulatory Manager

Major accountabilities:

Regulatory Strategy 

• Provide input to global program regulatory strategy, including regulatory designations & innovative approaches. 
• Coordinates regulatory readiness with other line functions, Country Organizations & Regions, representing RA or leads in regional RA or cross-functional activities providing strategic input into cross functional deliverables. 
• Contributes to the development and maintenance of key documents, determines the requirements and coordinates the activity for HA interactions.  

Regulatory Submissions 

•  Leads planning, preparation and submission of clinical trials.  
• Leads implementation of the defined global registration strategy into regional submissions worldwide by country organizations. 
• Coordinates, plans and prepares for submission of initial registrations and post approval applications, and the preparation, review and maintenance of local product information as assigned. 
• Lead regulatory activities during HA reviews, responding to questions and HA interactions. 

Regulatory Excellence & Compliance 

• Ensures timely RA input and submission of regulatory compliance and maintenance reports, maintaining regulatory information in compliance databases and document management systems. 

Your Experience: 

• Science based bachelors degree, plus an understanding of pharmaceutical development, clinical trials. 
• Track record of involvement in regulatory or pharmaceutical development, in one or more major regions. 
• Strong interpersonal skills and experience working in a complex, cross functional organization and leading cross function teams. 
• Compliance and Quality mindset. 
• Fluency in English. 

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 

Commitment to Diversity & Inclusion: 

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve. 

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