Job Title: Regulatory Affairs Specialist - Documentation
Job ID: REQ-10039385
Location: Hyderabad, India
Company: Novartis Healthcare Private Limited
About the Role:
The Regulatory Affairs Specialist - Documentation is responsible for managing controlled documentation systems and ensuring compliance with regulatory requirements related to product submissions. This role involves maintaining the technical and non-technical documentation change system, adhering to regulatory standards, and preparing regulatory dossiers. The specialist will collaborate with internal teams and external stakeholders to support global product registration and maintenance.
Key Responsibilities:
Regulatory Submission Management:
Manage medium to small-level global regulatory submission projects.
Contribute to regulatory strategy and provide technical support for global product development and registration.
Documentation Control:
Oversee documentation systems, ensuring compliance with regulatory standards for document formatting, policies, and operating procedures.
Enforce documentation standards and ensure proper classification and retention of records.
Global System Implementation:
Provide input for implementing global systems, tools, and processes to support development projects and marketed products.
Cross-functional Collaboration:
Engage with internal teams and external partners on specific regulatory projects.
Work on analyzing data and provide support for global regulatory strategies.
Compliance Reporting:
Ensure adherence to Novartis policies and guidelines in all regulatory documentation processes.
Report technical complaints, adverse events, and special case scenarios within the required timelines.
Key Performance Indicators:
Adherence to Policies:
Ensuring compliance with Novartis policies and regulatory guidelines.
Project and Stakeholder Feedback:
Successfully manage submission projects and receive positive feedback from key stakeholders.
Minimum Requirements:
Experience:
Cross-cultural experience and the ability to collaborate across boundaries.
Experience in project management and documentation management, with a focus on regulatory compliance.
Skills:
Proficiency in clinical study reports, data analysis, documentation management, and regulatory compliance.
Expertise in life sciences and operational excellence.
Languages:
Proficiency in English.
Why Novartis?
At Novartis, we are dedicated to improving the lives of patients by focusing on innovative science. Joining Novartis means becoming part of a passionate community that works together to achieve breakthroughs in healthcare.
Diversity & Inclusion: Novartis fosters an inclusive environment with diverse teams.
Benefits & Rewards: Learn more about Novartis benefits and rewards.
How to Apply
To apply for this role, visit the Novartis Career Portal.
Additional Information
Accessibility: If you require accommodations due to a medical condition or disability, please contact diversityandincl.india@novartis.com.
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