Cindavi•Regulatory Affairs Manager
Regulatory Affairs Manager at Cindavi
Interview Preparation Plan
Created 12/14/2025
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Role - Insider Insights
The Regulatory Affairs Manager role at Cindavi is a critical position focused on ensuring that products meet all necessary regulatory requirements throughout their lifecycle. This involves developing and implementing regulatory strategies, preparing and submitting documentation to health authorities, and staying abreast of evolving regulations. The manager will play a key role in guiding product development from a regulatory perspective, ensuring compliance, and facilitating market access. This position requires a deep understanding of regulatory frameworks and a proactive approach to managing compliance risks.
Key Responsibilities
- Develop and execute regulatory strategies for product development and lifecycle management.
- Prepare, review, and submit regulatory filings (e.g., IND, NDA, 510(k)) to health authorities.
- Interpret complex regulations and guidance documents to assess impact on products and business.
- Collaborate with cross-functional teams (R&D, Quality, Manufacturing) to ensure regulatory compliance.
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