Job Description:
Performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company as well as internal audits and inspections. Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitors and improves tracking/control systems. Keeps abreast of regulatory procedures and changes. May direct interaction with regulatory agencies on defined matters. Recommends strategies for earliest possible approvals of clinical trials applications. General application of concepts and principals to resolve a variety of issues. Works on problems of a moderate scope where analysis of situation or data requires a review of a variety of factors. Normally receives general instructions on routine work and detailed instructions on new projects or assignments. Typically requires a degree and a minimum of 2 years of experience.
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