Role Summary
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. Responsibilities
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 Qualifications
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 company’s 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 development, preparation and management of IND/CTA/MAA/NDA/BLA Demonstrated leadership expertise in preparation and preferably, negotiation to marketing approval in major markets
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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. Responsibilities
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 Qualifications
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 company’s 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 development, preparation and management of IND/CTA/MAA/NDA/BLA Demonstrated leadership expertise in preparation and preferably, negotiation to marketing approval in major markets
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