Global Regulatory Manager, GRSSC
Full Job Posting
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 9 to 13 (at least 7 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
- Skills Desired
- Data Analysis, Regulatory Compliance, Waterfall Model
Qualifications
- Data Analysis, Regulatory Compliance, Waterfall Model
Preferred Qualifications
- Desired
About Novartis
Multinational pharmaceutical company researching and manufacturing innovative medicines.
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