Associate Director/Director Regulatory CMC APPLY NOW
Location: New York or New Jersey
If you are interested in the below position, please send your resume to email@example.com and REFERENCE THE POSITION TITLE within the subject line.
The Associate Director/Director Regulatory CMC reports to the Vice President of Regulatory CMC. He/ she is responsible for managing the Company’s Regulatory CMC function to enable clinical development, marketing authorization, manufacture and distribution of clinical supplies and commercial products. He/ she supports the strategic and operational leadership required to ensure Regulatory CMC compliance with global (both US and ex-US) regulations and submission requirement for clinical studies and commercial supply.
This Regulatory CMC leader is responsible for strategy decisions and risk mitigations for regulatory submission issues related to CMC. He/ she ensures effective collaborations and partnership with Quality and technical functions within the Company, as well as external partners and suppliers. He/ she also supports the growth of the organization as development assets advance through the clinical research process and are commercialized for distribution.
––Responsible for the coordination, preparation, review and timely filing and maintenance of regulatory submissions (INDs, NDAs, DMFs, CTAs, amendments, safety reports, annual updates, briefing documents, pre-meeting packages, post approval submissions and marketing applications to the FDA, and if required international regulatory authorities), and ensure appropriate follow-up correspondence.
––Leads the hands-on preparation and coordination in preparation and authorship of regulatory documents in clinical programs, CMC, quality, process improvement and laboratory control.
––Coordinate and lead the task of drafting responses to CMC related questions from FDA or foreign health authorities.
––Work with functional groups to provide timely responses to CMC questions from regulatory authorities.
––Coordinates activities for meetings with FDA and other regulatory authorities.
––Interprets and communicates regulatory expectations to internal and external stakeholders (including partners, CROs, CMOs, consultants, and contractors) to execute program objectives in compliance with applicable regulations.
––Coordinates with cross functional teams to define contributions to submissions.
––Maintains current knowledge of regulations and guidelines (FDA, ICH and other as required).
––Ensures compliance with health authority regulations.
––Executes global CMC regulatory submissions for development projects or marketed products to achieve optimal submission/approval results and ensure regulatory compliance.
––Reviews clinical study protocols, clinical study reports, investigator brochures and CMC reports.
––Interprets pre-clinical and clinical results and develop those into sound regulatory positions and strategy.
––Develops and maintains cooperative relationships with external vendors and regulatory health authorities.
––Communicate CMC regulatory strategy, key issues and remediation activities needed throughout project/product life cycle to project team and appropriate management levels within and outside of Regulatory CMC.
5 – 10 years experience in regulatory CMC
BS in a scientific field, advanced degree preferred
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