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Global Submission Specialist
2 months ago
Job Title: Compliance Manager
Job Summary:
We are seeking a highly skilled Compliance Manager to join our team at Novartis. As a Compliance Manager, you will be responsible for managing the delivery of cross-functional submission documentation, overseeing submission publishing activities, and ensuring compliance with regulatory requirements.
Key Responsibilities:
- Manage the delivery of cross-functional submission documentation, including the compilation and submission of regulatory documents.
- Oversee submission publishing activities, including the dispatch of HA compliant, worldwide regulatory submissions.
- Ensure compliance with regulatory requirements, including eCTD and non-eCTD formats.
- Lead and manage multiple and simultaneous global regulatory submissions.
- Drive cross-functional teams focused on planning, overseeing compilation activities, and dispatch of worldwide regulatory HA submissions.
- Provide guidance to global project teams on worldwide HA submission format/requirements, filing strategy, eCTD document lifecycle management, and submission compilation workflows.
- Partner across multiple cross-functional functions, troubleshoot submission technical/quality issues, and manage the efficient use of global resources.
- Organize, lead, and participate in both internal and external stakeholder meetings.
Requirements:
- Bachelor's degree in life sciences or relevant discipline.
- Regulatory affairs or regulatory submissions related experience in global HA regulatory formats and submissions publishing activities.
- Proven enterprise mindset and quality driven.
- Strong interpersonal/project/time management skills and experience managing through complexities in a fast-paced, global cross-functional organization.
- Fluency in English.
Why Novartis:
At Novartis, we are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. We believe that our employees are our greatest asset, and we strive to provide a work environment that is supportive, challenging, and rewarding.
Benefits and Rewards:
We offer a comprehensive benefits package, including competitive salary, comprehensive health insurance, retirement savings plan, and paid time off. We also offer opportunities for professional growth and development, including training and education programs, mentorship, and career advancement opportunities.
