Will provide input for the Chemistry, Manufacturing, and Controls (CMC) strategic regulatory direction and operational CMC regulatory expertise to advance Array’s drug candidates. Responsible for timely preparation and maintenance of CMC sections INDs and NDAs including tracking and assembly of new INDs, NDAs, and amendments, supplements, Annual Reports, international filings, and other documents as necessary. The ideal candidate will have a direct role in implementing regulatory CMC policy throughout the drug development process. The candidate must be a credible, influential spokesperson for interactions and negotiations on CMC issues with regulatory authorities and agencies.
• Contributes to the development of CMC regulatory strategy
• Assist in the design and implementation of strategy to advance projects through development to product registration
• Will have a comprehensive understanding of CMC regulatory requirements including FDA, EMA, ICH guidelines and relevant government regulations as they apply to the registration, development, and approval of investigational products as well as post approval changes to marketed products
• Drives the CMC documentation to regulatory agencies (IND/CTA, NDA/MAA) setting the standards for CMC regulatory submissions to assure adequacy, completeness and regulatory accuracy
• Coordinates the preparation of CMC submissions through editing and approval of final draft documents, including review for quality.
• Coordinate preparation of information and related activities for CMC meetings with health authorities
• Assist in the identification of content, responsibility, and timing of CMC documents for regulatory submissions
• Acts as a direct contact point with health authorities for CMC issues
• Responsible for IND maintenance including amendments and annual reports and timely regulatory approval and registration of clinical supplies, including regulatory process compliance.
• Maintains effective relationships with CMC functional areas
• Liaise with partnering companies to ensure CMC regulatory alliance
• Degree in chemistry or other scientific discipline (graduate degree is preferred) plus training in regulatory affairs
• 10 years or greater in the pharmaceutical industry with a minimum of 5 years in CMC regulatory
• Ability to contribute extensive regulatory CMC expertise and advice
• Experienced in preparing / reviewing regulatory IND/CTA and CTD NDA paper and/or electronic CMC submissions
• Experience with anti-cancer oral and injectable products is a plus
• Collaborative team player that can establish and maintain effective working relationships with other departments, regulatory agencies, and outside vendors and act as an effective and persuasive spokesperson on CMC regulatory issues for assigned projects.
• Must be detail-oriented with good oral and written communications skills; able to supervise the preparation of accurate, clear and concise regulatory documents
• Maintain a strong working knowledge of FDA and ICH guidelines and the application of these guidelines to the CMC portion of regulatory submissions.
• Experience interacting with the FDA, Health Canada and European regulatory agencies desired
• Proficiency with Word and PowerPoint is required. Experience with Excel and MS Project is desired.
Array BioPharma Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule drugs to treat patients afflicted with cancer and inflammatory diseases. We offer an excellent compensation package including a competitive salary, company ownership and comprehensive benefits.
Array is an equal opportunity employer and drug free workplace.
Array BioPharma - 20 months ago