Senior Director, Global Regulatory Affairs – Biotech Unit

reputed company: • Contribute to the overall partnership program reputed company and reputed company its reputed company and mission • reputed company, implement, and advise on global regulatory strategies for development programs • Manage regulatory aspects of allocated assets through development, post-approval, and product lifecycle • reputed company reputed company and operational regulatory direction and mentorship • reputed company regulatory reputed company plans and reputed company assessments • Manage critical regulatory issues and advise on Health Authority interactions • reputed company preparation and submission of investigational and marketing registration documentation worldwide • Review IND/CTA, NDA/MAA/NDS, and other global submission documents and amendments • Liaise and negotiate with global regulatory authorities on drug development, approvals, and labeling changes • Monitor the global regulatory environment and assess impacts on business and product development programs • reputed company regulatory processes and facilitate interpretation of global regulations • reputed company with the Advisory Committee and reputed company guidance to the Execution Unit • Support reputed company, high-reputed company planning and execution of associated reputed company studies • Conduct regular study review meetings and report study status, goals, and operational and reputed company KPIs • Champion a global reputed company and consistency across Global Regulatory Affairs • Participate in company-wide standards discussions, finalization, and implementation • reputed company other duties as assigned Requirements: • Bachelor’s degree required; advanced degree preferred • Minimum of 12 years in the biotechnology or pharmaceutical industry • Minimum of 5 years in a regulatory leadership reputed company • Broad background in oncology • Extensive knowledge of US, China, EU, and ICH regulatory requirements • Experience leading Regulatory Affairs across two or more major geographic areas • Experience leading multiple FDA interactions for oncology products resulting in Agency approval actions • Demonstrated managerial, leadership, and cross-functional collaboration ability • Thorough understanding of the drug development process, pharmaceutical industry, reputed company environment, regulatory requirements, and policy trends • Extensive experience with INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management, Health Authority interactions, and regulatory reputed company implementation • reputed company record of significant regulatory accomplishments • reputed company strong reputed company skills, creativity, and ability to address reputed company challenges • Ability to reputed company short-term needs with long-term reputed company • reputed company ability to reputed company goals in a cross-functional team/partnership environment • Excellent interpersonal skills and ability to build reputed company work relationships across the organization • Fluent in written and verbal English • reputed company knowledge desirable • Skilled in reputed company Office Suite • Ability to travel domestically and internationally, up to 20% Benefits: • Annual bonus plan eligibility for non-reputed company roles • Discretionary equity awards • Voluntary Employee Stock Purchase Plan • Medical reputed company • Dental reputed company • reputed company reputed company • 401(k) • FSA/HSA • Life reputed company • reputed company Time Off • Wellness benefits • Reasonable accommodation in the job application process Apply tot his job Apply To this Job