Sr. Regulatory Affairs Specialist - Abbott Nutrition Division
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Job Description
The Opportunity
Key Areas of Accountability:
1. Submissions and Approvals
a) Dossier Preparation
Prepare a quality regulatory dossier for Food/Nutritional (major brands), Drugs, Medical Device products and submit within the planned affiliate timelines.
Request and obtain the various regulatory items needed for the local submission
Reviews Clinical Documentation to support product label claims
Prepare/format the dossier to ensure it meets local requirements
Implement the submission and archive appropriately
b) Gain Regulatory Approval
Gain Food and Drug Administration (FDA) or respective regulatory agency approvals to meet the affiliate product launch plans and ensure product maintenance.
Provide quality responses to the FDA on or before the due date
Complete regulatory approval process and gain product licenses.
Communica...