Senior Regulatory Affairs Specialist - Omaha

Only for registered members Omaha, United States

1 month ago

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Job summary

The Senior Regulatory Affairs Specialist recommends process improvements, updates regulatory SOPs, applies broad regulatory knowledge to support compliance across various geographies and submission types.
Serve as RA Representative on project teams, develops regulatory submission strategies for new product launch, provides regulatory guidance to the project teams.
Negotiate and interact with regulatory authorities during the development and review process to ensure timely submission approval.
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