Senior Director/Director, Regulatory Affairs CMC

Position Overview

The Regulatory Director/Sr. Director Regulatory CMC will be responsible for preparing CMC and Quality related health authority agency correspondence and regulatory applications, as well as govern CMC submissions and regulatory compliance support for the development of global products. This position will lead regulatory activities to support high quality CMC sections of regulatory documentation.

Responsibilities

• Provide regulatory CMC strategic leadership within Regulatory and on cross-functional teams to support development of innovative genomic medicines/ex-vivo and in-vivo therapies.
• Develop and proactively communicate regulatory CMC strategies, risks and key issues in an evolving regulatory landscape.
• Act as the regulatory CMC lead and department representative in matrix teams for development programs.
• Support development of manufacturing, analytical, and supply chain strategies and provide expert regulatory guidance to enable global implementation.
• Define CMC content (data and documentation) requirements for quality sections of regulatory dossiers (IND/CTA/MF and BLA/MAA).
• Plan and manage activities for the preparation of high quality CMC-related global regulatory submission elements, including authoring and/or critical review to ensure compliance with regulatory requirements, scientific excellence, accuracy, source information traceability, and consistency with related filings in accordance with program timelines.
• Providing critical review of detailed scientific information described in CMC documents and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data.
• Evaluation of CMC-related change proposals for regulatory impact and filing requirements; provide strategic regulatory guidance for optimal implementation of changes.
• Develop regulatory processes and procedures to support CMC components of regulatory submissions.
• Support the creation and maintenance of CMC submission templates and dossier standards.
• Lead and support global health authority interactions for CMC-related topics including defining strategy, preparation, and meeting facilitation.
• Support Quality Assurance in preparing and hosting GMP and pre-approval inspections.
• Develops and maintains collaborative partnerships with key internal and external stakeholders.
• Participate in regulatory intelligence activities, monitor regulatory guidelines and trends as they pertain to global CMC regulations and guidance, and provide regulatory advice to CMC and project teams regarding the applicability/impact on internal programs; anticipate and communicate possible regulatory paradigm shifts.

Qualifications

• BA/BS degree in a scientific/engineering discipline with 15 + years experience, 10 of which in the biotech industry; Level will be commensurate with experience.
• 9+ years experience in Regulatory CMC, or related experience (e.g., manufacturing, analytical, quality assurance) with direct technical writing experience for IND/CTA/MF and BLA/MAA submissions.
• Experience with cell and gene therapy and/or lipid nanoparticles is desirable.
• Comprehensive knowledge of regulatory (FDA. EMA, and ICH) guidelines; with a demonstrated ability to articulate and apply these principles to regulatory CMC strategies for novel products.
• Diverse experience including biologics in the cell therapy space, drugs, and international filings preferred.
• Strong experience with CTD format and content regulatory filings.
• Excellent organizational, written/oral communication, and time management skills; ability to communicate complex issues in a succinct and logical manner; strong listening skills.
• Experience with related CMC disciplines (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.
• Ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders; flexibility in responding to changing priorities and/or unexpected events.

Onsite requirements: candidates are expected to come onsite 1-3 days per week.