The Senior Director, CMC Regulatory Affairs will be responsible for providing CMC regulatory leadership and strategy across the organization and to our global partners. The Sr Director, CMC Regulatory Affairs will collaborate with the clinical development team, including the Chief Scientific Officer and drug substance and drug product manufacturers, and others for drug development and manufacturing in the pharmaceutical and biotech industry in accordance with the protocol, standard operating procedures (SOPs), ICH-GMP, and all applicable regulatory requirements.
Primary Responsibilities include but are not limited to the following: ? Writing regulatory submissions and serving as in-house regulatory expert to internal and external parties. ? Responsible for maintaining up to date knowledge of CMC regulatory affairs. ? Serve as a liaison between our company and regulatory bodies for CMC related questions. ? Coordinate the preparation and timely submission of responses to regulatory agencies. Manage timelines to ensure that approvals are timely and development objectives are met. ? Responsible for overseeing manufacturing with the intent of obtaining clinical-grade material. ? Ensure continued management, development and process improvement of CMC related activities within the organization in response to agency feedback or changes in the regulatory environment. ? Manage GMP audits at manufacturing and distribution facilities. ? Lead/participate in meetings with internal stakeholders and external business partners or teams for clinical development programs or collaborations, in order to communicate regulatory CMC guidance and strategies. ? Write Divisional SOPs and develops and implements training programs for direct reports and other functional groups to assure awareness of all requirements and maintain compliance with all current regulation activities subject to regulations established by US, EMA, and other relevant global health agencies. Education and Skills Requirements: ? M.S. or PhD in chemistry, biology, pharmacology, or closely related field. ?
Minimum of 10 years of regulatory affairs industry experience specific to small molecule manufacturing. ? Significant CMC and line management experience with demonstrable knowledge of the manufacturing and regulation of biotechnology products for human use. ? Successful experience in negotiations with regulatory bodies and experience writing CMC documents that comply with regulatory requirements. ? Experience within drug development and in the authoring/review of CMC related documentation such as updates and amendments, IMPD, IND and MAA/NDA ? Experience in analyzing and interpreting global regulations and scientific publications and using this information to solve complex CMC Regulatory issues. ? Ability to convey and present complex information to others clearly and logically. ?
Excellent communication skills and proficiency with Microsoft Outlook, Excel, Word, PowerPoint and Project. ? Ability to maintain high standards of professionalism, quality, and prioritization. ? Able to collaborate and work in a small, yet dynamic team environment. ? Proven ability to operate in a home office environment with flexibility to travel and report to corporate office, as appropriate.