Regulatory Affairs Director oversees regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Director establishes monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)
Description:
Managing the preparation of regulatory submissions for IND ANDA NDA 510K AdProm and other electronic submission types o Creating timelines for regulatory filings o Providing and maintain templates for authoring. o Overseeing authoring and reviewing of regulatory documents o QC submission documents Contribute to the development of process improvements and procedural documents. Identifying and assessing regulatory risks and risks to timelines. Providing regulatory updates to the project team on different milestones. Working cross functionally with project management operations IT and other functions. Coordinate submission scheduling with regulatory publishing and ensures delivery of high-quality documents. Working closely with other members of the Regulatory team and provide support to their projects as needed. Maintaining archival of submissions and health authority communications in Veeva RIM system. Provide regulatory representation on key meetings including meetings with health agency.
Skills:
Regulatory Affairs, FDA, Regulatory Submissions, IND, NDA, 510K, Pharmaceutical, Medical Device, Quality Assurance
Top Skills Details:
Regulatory Affairs,FDA,Regulatory Submissions
Additional Skills & Qualifications:
BS Degree with 2-4 Years of related Regulatory Affairs experience US FDA Experience with Veeva Vault systems is preferred.
Experience Level:
Intermediate Level
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