Job Description

A client of mine based in North Carolina are looking for a Regulatory CMC Executive Director that has strong, deep and proven expertise in biological and cell therapy products. The appropriate Chemistry, Manufacturing and Controls of each product within the organizational pipeline, including commercial-stage, clinical stage and pre-clinical products and product candidates.

The successful candidate will have outstanding knowledge and understanding of regulatory requirements for CMC, strong leadership skills, excellent strategic planning to support generation/review and submission of regulatory documentation for complex manufacturing processes, and a solutions-focused mindset with the proven ability to solve problems from simple to complex. This position will report to the Chief Regulatory Officer.

Position Overview:

• Generate, review, and approve regulatory submissions associated with CMC
• Lead and manage the RA CMC team; mentor RA CMC team members
• Develop current and long-term strategies and objectives for regulatory CMC, that align with overall company strategy and seek approval from executive leadership and implement strategic plans in collaboration with Manufacturing and Process Development
• Participate with executive leadership to proactively identify potential regulatory CMC risks to the organization, make adequate recommendations for mitigating risks and collaborate with other senior leaders in Manufacturing, MSAT and Process Development to implement selected and agreed upon strategies across all areas of the organization
• Assure sustainable, harmonized regulatory compliance for manufacturing sites and contracted manufacturing operations (as applicable) through expert level insight, evaluation and support
• Identify and implement regulatory requirements for Design and Development, Technology Transfer, and Manufacturing/Bioprocessing
• Collaborate with Quality on Regulatory communications associated with U.S. and international regulatory inspections, including Pre-Approval Inspections
• Serve as the main point of contact with Development, MSAT, Manufacturing, Quality Assurance, Validation, and Quality Control regarding CMC regulatory compliance and reporting requirements
• PO for CMC discussions at meetings with regulatory authorities, including U.S. FDA and other competent authorities
• Prepares, reviews, and approves correspondences, submissions, protocols, and reports in support of regulatory filings(IND, IMPD, BLA, MAA, etc.)
• Maintain consistent application of ICH Q9 Quality Risk Management principles in product development and lifecycle operations
• Manage and maintain policies, processes, and procedures associated with the companies Tissue Processing operations (internal or contracted) per 21 CFR Part 1271 and international regulations related to Human Cells, Tissues, and Tissue-Based Products
• Demonstrate and apply thorough understanding of U.S. FDA, EU, and Rest of World (ROW) regulations with respect to aseptic processing, biologics manufacturing and market authorization, market authorization, and human cell and tissue-based products, including but not limited to: 21 CFR Parts 11, 210, 211, 600, 820, and
• 1271; and relevant European Directives (EudraLex Volume4, 2001/83/EC, 2004/23/EC)

Required Skills:

• Minimum 10 years in a Director-level and above role in Regulatory CMC in a Biotechnology-related field
• Demonstrated experience in collaborating with the Quality department to prepare for and execute regulatory inspections including preparation, representation, and closing out of observations
• Proven record of CMC writing, reviewing, and approving regulatory submissions on topics of biological and cell therapy CMC processes and compliance, including pre- clinical stage, clinical stage, and commercial-stage products and product candidates
• Demonstrated experience in developing, communicating, and implementing regulatory and compliance strategies to assure success in design, development, and commercialization processes for biologic products and medical devices
• Demonstrated knowledge of and expertise in product life cycle management, consistent with ICH and other international consensus guidance
• Demonstrated success with planning, executing, and closing international regulatory inspections, with a focus on European regulatory submissions

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