Regulatory affairs

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Regulatory Affairs


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Regulatory Affairs in the life sciences industry — including pharmaceuticals, biotechnology, and medical devices — is all about ensuring that products meet all legal and regulatory requirements for safety, efficacy, and quality. It acts as the bridge between the company, regulatory authorities, and the market. Here’s a breakdown of the role:

Responsibilities:

  • • Regulatory Strategy Development

  • • Submission Preparation and Management

  • • Regulatory Intelligence

  • • Compliance and Risk Management.

  • • Lifecycle Management.

  • • Cross-functional Collaboration