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Director of Global Regulatory Compliance
1 week ago
The successful candidate will have practical knowledge and experience to provide guidance to program teams on the regulatory requirements, processes, and logistics to conduct global drug development activities for biologic (gene therapy, other biologics) and small molecule compounds from the preclinical stage through the initial marketing application, and life cycle management. Key responsibilities include:
• Developing and implementing global regulatory strategies to ensure earliest possible marketing approvals by global regulatory authorities
• Authoring and preparation of various submission documents, meeting requests, briefing documents; coordination and preparation of teams for health authority meetings
• Providing strategic guidance on global regulatory requirements to management and project teams on all regulatory issues for the strategic development, planning, compilation, and submission of IND/CTA and NDA/MAA applications
• Serving as the designated program regulatory health authority contact. Representing the company by leading interactions with regulatory agencies during all stages of development, registration and commercialization
• Overseeing development of dossier filing plan and associated regulatory activity timelines
• Integrating global regulatory understanding and responsibilities in developing strategy and development of regulatory submission documents
• Providing critical review of all documentation supporting regulatory applications; ensuring compliance with internal data standards and regulatory authority submission requirements
• Actively engaging with stakeholder groups to help shape science-based regulatory decision-making
• Acting as strategic regulatory liaison with partner companies