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Orca-Bio

Remote Regulatory Affairs Lead – Post‑Approval Strategy

menlo park, CA

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About this opportunity

Orca-Bio lists this Remote Regulatory Affairs Lead – Post‑Approval Strategy opportunity in menlo park, California. Review the employer’s description below for duties, qualifications and application requirements.

Job description

Orca Bio is seeking a Senior Director of Regulatory Affairs to lead the regulatory function as the company’s senior regulatory expert. You will partner with the CMO to shape regulatory strategy, manage health-authority engagements, and oversee post-approval lifecycle activities.

With a focus on post-approval operations, labeling, and lifecycle maintenance, you will guide the Regulatory Affairs team and coordinate with Quality and cross-functional partners to ensure readiness for future programs

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Worksite address

menlo park, CA, 94029, US

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