Director, CMC Regulatory
The Director of CMC Regulatory is accountable for the development and implement global regulatory chemistry, manufacturing, and control (CMC) strategies for small molecules products from development through marketing approval for the US and EU markets. Responsible for regulatory leadership, support and preparing CMC aspects of US IND, NDA and global regulatory submissions, ensuring compliance to all applicable regulations and standards. Interface with Regulatory Agencies, such as FDA, and competent authorities as required.
This position will collaborate with functional areas to provide regulatory guidance on quality related issues, provide the best possible CMC regulatory strategies that integrate with plans for other disciplines and company objectives, and to ensure timely and accurate preparation and review of regulatory submissions and related CMC documents.
· Function as regulatory CMC lead for assigned products
· Provide strategic CMC regulatory interpretation and guidance to project teams from early development through post-approval
· Develop and execute the regulatory strategy (CMC aspects) to support the lifecycle of assets; determine from a strategic and scientific perspective the content of relevant CMC sections (technical and/or procedural) of project/product specific documents submitted to regulatory agencies (e.g. NDA, MAA, INDs, IMPDs, etc.) and ensure that these documents meet high scientific standards and regulatory requirements
· Lead project/product-related discussions and provide strategic, scientific, and regulatory input, for regulatory CMC aspects
· Creation of quality section of regulatory filings; compile/write/review specific CMC documents to be submitted to regulatory agencies (e.g., INDs, BLAs, IMPDs, MAAs, and other relevant regulatory filings) and ensure that those documents meet regulatory requirements.
· Review quality submission documents to ensure consistency with related filings, industry standards and regulatory requirements
· Review CMC protocols/test methods; review and approve clinical manufacturing plans and labeling, and authorize drug shipment to clinical sites
· Providing regulatory assessments for proposed changes to investigational and commercial products
· Interact with manufacturing and quality groups, contract, and partner organizations, regarding regulatory CMC issues; assess impact of manufacturing changes pertaining to approved commercial products
· Serves as corporate liaison for CMC with regulatory Health Authority (HA) to develop effective professional relationships as well as a positive company image.
· Makes recommendations for regulatory department operating procedures. May be responsible for creating and reviewing SOPs as needed.
· Minimum of a BS degree, MS degree or advanced degree (PhD/PharmD) highly desirable
· A minimum of 12+ years of experience in regulatory project management, development, scale-up and clinical/commercial development and manufacturing in the pharmaceutical industry.
· Experience in research, process development, and manufacturing
· Extensive experience in leading small molecule processes and analytical development
· Advanced knowledge of regulatory requirements, including ICH and FDA.
· Excellent leadership, managerial and communications skills in a cross-functional environment
· Proficiency in analysis of scientific data and results with ability to review scientific documents including reports, publications and regulatory submissions.
· Experience in the conduct of global clinical trial programs including Phase 3.
· Demonstrated consistent achievement of team delivery against commitments and goals.
· A strategic thinker and creative problem-solver capable of identifying risks and risk mitigation strategies.
· Possesses excellent teamwork, negotiation and influencing skills, able to work in a matrix project team setting and a proven track record establishing and achieving clear and consistent goals and objectives.
· Excellent verbal and written communication skills.
· Strong scientific writer and oral presenter.
· Courage to be an "out of the box" thinker, to take on calculated risks, and champion new ideas and approaches with the development team.