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Accountabilities:
- Independently manage regulatory activities for standard and complex submissions.
- Prepare and contribute to regulatory submissions, including pre-approval and lifecycle management.
- Support health authority interactions and provide regulatory expertise.
Requirements:
- Proven experience in CMC regulatory affairs across global markets.
- Strong understanding of submission processes and health authority interactions.
- Excellent project management and communication skills.
Benefits:
- Fully remote work opportunity from India.
- Exposure to international regulatory environments and complex projects.
- Career development through training, mentorship, and continuous learning.
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The company provides regulatory consulting services for healthcare products, focusing on global markets. It fosters a collaborative, inclusive culture with opportunities for career development and meaningful impact.