Director Regulatory Affairs - CMC

About the Role:

Responsible for the strategic Regulatory CMC leadership for assigned commercial products to ensure regulatory compliance with the approved marketing applications (MAA/NDA/BLA) and assigned development projects leading to successful preparation and clearance/approval of IND/CTA/MAA/NDA/BLA submissions in a timely and efficient manner.

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Your Contributions (include, but are not limited to):

• Responsible for the regulatory CMC leadership of one or more commercial and development projects, including responsibility for regulatory strategy, IND/CTA preparation, maintenance and update activities, interaction with and preparation for key milestone meetings with regulatory agencies with focus on the CMC aspects


• Develops CMC regulatory strategies to ensure optimal product development leading to the earliest possible approvals by relevant regulatory authorities


• Provides strategic guidance on global regulatory CMC requirements to management and project teams


• Provides guidance to senior management and departments within CMC areas on all regulatory issues for the strategic development, planning, compilation and submission of assigned IND/CTA/MAA/NDA/BLA


• May represent the company by leading interactions and negotiations with regulatory agencies during all stages of development and registration


• Manages preparation of assigned regulatory submissions (IND/CTA/MAA/NDA/BLA)


• Reviews and approves reports intended for use in regulatory submissions


• Actively engages with stakeholder groups to help shape science based regulatory decision making


• Acts as regulatory CMC liaison with partner companies and contract manufacturers


• Provides expertise in translating regulatory requirements into practical, workable plans


• Interacts with regulatory agencies for assigned projects


• Selects, develops and evaluates personnel to ensure the efficient operation of the function


• Other duties as assigned

Requirements:

• BS/BA degree AND 12+ years experience in Regulatory Affairs in the Pharmaceutical/Biotech industry. Prior project regulatory leadership experience with specific focus on the CMC aspects for small molecules, biologics, and/or gene therapies. Leadership experience in preparation and preferably, negotiation to marketing approval in major markets is desired. OR


• Master's degree preferred AND 10+ years similar experience noted above OR


• PhD preferred AND 7+ years similar experience noted above OR


• Extensive previous managerial experiences also required


• Acts as a "trusted advisor" across the company and may be recognized as an external expert


• Provides strategy, vision and direction regarding issues that may have company-wide impact


• Requires in-depth knowledge of the functional area, business strategies, and the companys goals


• Possesses industry-leading knowledge


• Ability to apply advanced analytical thought and judgment


• Strong leadership, coaching, employee development skills


• Ability to influence others with or without authority at all levels of the organization


• Proactive, innovative, with excellent problem-solving skills


• Ability to work in a cross functional team and matrix environment


• Excellent written, presentation, and verbal communication skills


• Extensive project regulatory leadership and expertise, specifically focused on the CMC aspects for small molecules, biologics, and/or gene therapies


• Detailed knowledge of FDA and EMA regulations and guidance for drug devel