Major accountabilities:

• Manage manufacturing transfer projects and represent regulatory affairs in cross-functional teams
• Ensure with limited supervision that maintenance submissions are prepared on time and in compliance with regulatory regulations, guidelines, and in line with Novartis processes and system requirements.
• Responsible for providing strategic regulatory input for the preparation of cross functional deliverables (e.g. variations/supplements, renewals, annual reports)
• Uses regulatory expertise and portfolio knowledge to identify issues, gaps, and tradeoffs to avoid/minimize delays and to achieve timely submission and approval.
• Manages timely response to HA queries and contribute to preparing strong justifications to address regulatory gaps
• Responsible for appropriate entering of product specific attributes in compliance database and applicable RIMs
• Manage preparation and finalization of documents for HA interactions
• Contribute to non-project related initiatives focused on productivity, continuous improvement, and automation
• Support other associates within Regulatory Affairs by providing training on specific topics and act as a Subject Matter Expert

Your Experience: 

Education:

(required and preferred)

Science based BS or MS with requisite experience and demonstrated capability.  Advanced degree (MD, Ph D, PharmD) preferred.

Languages:

(required and preferred)

Fluency in English – Additional language is an asset. 

Experiences & Skills:

• 4+ years of knowledge and experience in regulations, guidelines and regulatory processes for regulatory maintenances activities
• Regulatory experience in manufacturing site transfers
• Experience with regulatory submission and approval processes
• Experience working and delivering results  in a global/matrix environment and with cross- functional teams
• Planning, execution, reporting, regulatory review, compliance and submission experience
• Ability to contribute to process improvements and operational excellence initiatives
• Reliable, timely, accurate and proactive communication as appropriate.

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? http://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. 

Join our Novartis Network:  

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