Job Title: Regulatory Affairs Manager – Labeling
Location: Hyderabad, India (Office-based)
Industry: Pharma / Healthcare / Clinical Research
Division: Development
Business Unit: Innovative Medicines
Job ID: REQ-10027723
Job End Date: 30th January 2025
Job Summary:
Novartis is seeking a Regulatory Affairs Manager specializing in Labeling to join its dynamic and talented team. The role involves managing the labeling strategy, regulatory intelligence, and knowledge needed for the development, marketing, and maintenance of products. You will be responsible for providing strategic labeling input for global development projects, reviewing labeling change information, and ensuring consistency with the application. You will work with regulatory agencies to ensure approvals for labeling and propose improvements for processes and systems.
Key Responsibilities:
- Review and assess local country labels to identify deviations from the core labeling and provide feedback during periodic core labeling reviews.
- Support the creation of high-quality documents for labeling-related Health Authority queries.
- Contribute to regulatory activities, ensuring the safety risk communications and portfolio stewardship for assigned projects/products are met.
- Manage and report technical complaints, adverse events, and special cases related to Novartis products.
- Work closely with internal and external stakeholders, including regulatory agencies, to ensure approval of labels.
Candidate Profile:
- Key Skills: Cross-cultural experience, project management, collaboration, operational excellence, and detail-oriented labeling documentation.
- Competencies: Regulatory compliance, functional breadth, labeling regulations, safety, and experience working across cross-functional teams.
- Additional Requirements: Experience with labeling-related Health Authority interactions and the ability to manage multiple projects.
Application Deadline: 30th January 2025