The Associate Director/Director, Global Regulatory Affairs will manage Clinical regulatory activities (including direct reports) for the oncology development program. This individual will represent Clinical Regulatory Affairs on project and submission teams and with global health authorities, and be responsible for timelines for IND/CTA and NDA/MAA submissions. Also responsible for ensuring that technical development programs are designed to meet regulatory requirements, and guide clinical-related programs to registration submissions and approvals.
Responsibilities:
Work closely with clinical and CMC development colleagues to develop regulatory submission strategies, review content, and maintain submission timelines to meet business objectives
Proactively identify regulatory issues and provide solutions to keep assigned programs on time, while maintaining the highest quality
Lead efforts for coordinating clinical content for original INDs, IND amendments, CTAs and NDAs
Work with department management on clinical plans for NDA/ MAA submissions and lead preparation and review
Take a lead role in preparations for Regulatory Agency meetings including drafting briefing documents with clinical focus
Participate in multidisciplinary efforts to prepare clinical updates for regulatory documents including
Review Investigator Brochures, Annual Reports, product labeling and Background Documents, safety submissions with a clinical focus
Work with regulatory organizations and partners in Europe and Asia to prepare applications and respond to queries to enable maintenance of clinical needs for clinical activities outside of the United States
Establish, manage, and maintain a knowledge base of current and emerging clinical regulatory requirements, guidelines, and best practices, and interpret and communicate relevant issues
Ensure communication and alignment on clinical regulatory strategy through partnership and communication with internal key stakeholders, including representing the regulatory department at strategy meetings
Assure compliance with regulatory standards and guidance documents
Prepare, submit, track, index, and archive electronic submissions
Ensure that clinical- related changes are reported to authorities in accordance with regulatory requirements
Conduct risk assessments of global clinical regulatory issues
Liaise with Medical Writing, contract CROs, and Regulatory Operations for coordinating and publishing submission documents
Manage department staff and vendors
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