Yhteenveto
The aGRM-RACS collaborates with the study team or with the Country lead and the line functions to ensures high quality (complete, well organized, scientifically accurate, compliant) submissions are prepared, reviewed and timely approved.
About the Role
Key Responsibilities:
- For a product portfolio, the aGRM- RACS ensures under supervision that clinical trial applications or maintenance submissions are prepared on time and in compliance with regulatory regulations, guidelines, and in line with Novartis processes and system requirements.
- Manage assigned product portfolio and country / region knowledge.
- Use regulatory expertise and knowledge to identify issues, gaps, and tradeoffs to avoid/minimize delays and achieve timely submission and approvals.
- Manage timely responses to HA queries and collaborate with regulatory lead to preparing strong justifications to address regulatory gaps.
- Responsible for appropriate entering of product specific attributes in compliance database and applicable RIMs.
- Facilitate preparation and finalization of documents for HA interactions for matters of low complexity.
- Contribute to non-project related initiatives focused on productivity, continuous improvement, and automation.
- Share knowledge on specific topics and support other associates within Regulatory Affairs.
Minimum Requirement
- Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred.
- Regulatory affairs experience of 7 to 10 (at least 5 years of relevant exp) with knowledge of regulations, guidelines and regulatory processes for maintenance activities
- Experience of regulatory submission and approval processes in major countries. Planning, execution, reporting, regulatory review, compliance and submission experience
- Ability to participate in process improvements, simplification, automatization and operational excellence initiatives
- Understand safety and efficacy data and product labels. Reliable, timely, accurate and proactive communication as appropriate
- Basic organizational awareness (e.g., interrelationship of departments). Experience in a global/matrix environment or cross- functional teams in the pharmaceutical industry
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
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Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
