Regulatory Affairs(Injectables)-Deputy Manager/Manager

Regulatory Strategy & Submissions:

• Develop and implement regulatory strategies for injectable products in ROW markets
• Prepare, review, and submit regulatory filings to regulatory authorities in international markets.
• Ensure compliance with local and international regulatory standards, ensuring that submissions align with local regulations.

Regulatory Compliance:

• Monitor and interpret changes to local, regional, and international regulatory requirements and assess their impact on injectable product development and commercialization.
• Provide guidance on regulatory aspects of labeling, packaging, and advertising materials.
• Support product lifecycle management by ensuring regulatory compliance from pre-market to post-market phases.

Cross-Functional Collaboration:

• Collaborate with R&D, quality assurance, manufacturing, and commercial teams to ensure regulatory compliance at all stages of product development.
• Communicate effectively with internal stakeholders regarding regulatory requirements and timelines.
• Support in the preparation of responses to regulatory authority queries and inspections.

Documentation and Reporting:

• Maintain accurate and up-to-date regulatory records and documentation.
• Prepare and manage submission dossiers for global health authorities, ensuring completeness, accuracy, and adherence to timelines.
• Assist with the preparation of regulatory reports for internal and external stakeholders.

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