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Our Regulatory Affairs team brings essential generic quality medicines to our hospital members in the United States by providing CMC Regulatory leadership and establishing Civica’s Regulatory Affairs systems and processes. The Manager, Regulatory Affairs Labeling:
Manages and coordinates all aspects of product labeling artwork development and approval for Civica’s private label distributor products.
Creates, updates, and maintains labeling documents throughout the product lifecycle for Civica-developed products.
Develops and maintains labeling procedures that comply with FDA, GMP, ISO and other applicable standards and regulations. Maintains expertise regarding key labeling requirements and stays current with labeling guidelines and regulations as they pertain to the development/maintenance of labeling and advises key stakeholders on the application of these labeling principles.
Coordinates and prepares Office of Prescription Drug Promotion (OPDP) submissions.
Assists with other Regulatory Affairs department functions as needed, including Chemistry, Manufacturing and Controls (CMC) submissions, annual report preparation, change control processing, etc.
Responsibilities, include but not limited to:
Works closely and coordinates with the supply chain and contract manufacturers and packagers to ensure that revised labeling is implemented in a timely manner.
Maintain Civica’s drug listings.
Monitors for and implements safety labeling updates as dictated by health authorities and/or internal pharmacovigilance.
Maintains controlled records for historical labeling changes and communicates labeling changes to stakeholders at the time of implementation.
Establishes a label review/change control process and implements process improvements to increase the efficiency and effectiveness of the process.
Ensures labeling information in regulatory submissions is complete and accurate.
Identifies and leads process for obtaining feedback from key stakeholders for continuous improvement.
Stays updated on agency’s expectations based on guidance documents and deficiencies and applies the same logic for future submissions to avoid any similar deficiencies
At least five (5) years of relevant experience within the pharmaceutical regulatory environment, with a concentration in pharmaceutical labeling and artwork development. Minimum of 2 years’ experience in a supervisory role. Additional pharmaceutical regulatory experience, including CMC development; manufacturing, testing, or licensure of generic pharmaceutical products, is preferred. The candidate must be proficient in English; additional language skills are a plus
Internal Number: 1234
About CIVICA INC
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