Associate Submission Manager

Associate Submission Manager

REQ-10015168
Aug 12, 2024
India

About the Role

Major accountabilities:
  • Manages medium to small level global regulatory submission projects.
  • Provide submission and contribute to the technical related regulatory strategy, intelligence and knowledge required to develop, register, and maintain global products.
  • Contribute to strategic and technical input /support to drive implementation of global systems, tools and processes to support global development projects and/or marketed products.
  • Frequent internal company and external contacts.
  • Represents organization on specific projects -Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
  • Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
Key performance indicators:
  • Adherence to Novartis policy and guidelines -Project & stakeholder feedback
Minimum Requirements:
Work Experience:
  • Cross Cultural Experience.
  • Functional Breadth.
  • Collaborating across boundaries.
  • Operations Management and Execution.
  • Project Management.
Skills:
  • Clinical Study Reports.
  • Data Analysis.
  • Documentation Management.
  • Lifesciences.
  • Operational Excellence.
  • Regulatory Compliance.
Languages :
  • English.

Role Requirements

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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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Biomedical Research
India
Hyderabad (Office)
Research & Development
Full time
Regular
No
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REQ-10015168

Associate Submission Manager

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