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.
_
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 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