Associate Director, Regulatory Affairs - Payrolling
Summary: Under limited direction, responsible for successfully filing original Abbreviated New Drug Application submissions and for managing post approval changes requiring regulatory submissions. Can be primary contact with regulatory authorities for assigned projects and products. Determines nature and scope of information to be generated to successfully file required regulatory documents. Keeps Company informed of significant regulatory issues that affect assigned products/projects. Essential Job Functions: This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks. Carries out managerial responsibilities in accordance with the organization?s policies, procedures, and state, federal and local laws. Directs, coordinates and prioritizes the strategic activities of the Regulatory Affairs Team and assigned staff. Reviews and approves regulatory submissions (i.e. ANDAs, amendments, supplements, etc.) to the Food and Drug Administration (FDA) to ensure compliance with applicable regulations and guidance?s. Review and approve change notices, specifications, batch records, standard test methods, etc. Implements policies to assure on-going compliance of Regulatory Affairs activities.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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