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