Associate Director/Director Regulatory Cmc

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 requirements 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 partnerships 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.

KEY RESPONSIBILITIES

• Maintains current knowledge of regulations and guidelines (FDA, ICH, and others as required).
• Executes global CMC regulatory submissions for development projects or marketed products to achieve optimal submission/approval results and ensure regulatory compliance.
• 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.
• 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.
• Reviews clinical study protocols, clinical study reports, investigator brochures, and CMC reports.
• Coordinates activities for meetings with FDA and other regulatory authorities.
• Coordinate and lead the task of drafting responses to CMC-related questions from FDA or foreign health authorities.
• Interprets pre-clinical and clinical results and develops those into sound regulatory positions and strategies.
• Work with functional groups to provide timely responses to CMC questions from regulatory authorities.
• Ensures compliance with health authority regulations.
• Coordinates with cross-functional teams to define contributions to submissions.
• Leads the hands-on preparation and coordination in preparation and authorship of regulatory documents in clinical programs, CMC, quality, process improvement, and laboratory control.
• 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.
• Develops and maintains cooperative relationships with external vendors and regulatory health authorities.

PROFESSIONAL EXPERIENCE/QUALIFICATIONS:

• 5-10 years experience in regulatory CMC

EDUCATION

• BS in a scientific field, advanced degree preferred