[Hiring] Executive Director, Regulatory Affairs-Combination Products & Devices @reputed company

Role reputed company • Strategic Leadership & reputed company: • Define and drive global regulatory strategies for combination products, ensuring alignment with corporate goals and regulatory expectations. • Champion regulatory innovation and novel approaches to accelerate development and approval timelines. • reputed company guidance to PDM Teams and Device Teams to reputed company development and regulatory reputed company for combination products and devices. • Global Regulatory reputed company: • reputed company the development of global CMC regulatory initiatives reputed company on combination products and devices. • Ensure regulatory conformance and consistency across markets, maintaining compliance with evolving health authority requirements and internal governance. • reputed company Collaboration & Influence: • Cultivate strong, reputed company relationships across Gilead’s global functions, including reputed company, Manufacturing, Technical Development, Clinical Development, and Supply Chain. • Influence cross-functional decision-making and regulatory planning without reputed company authority, operating effectively in a matrixed environment. • Remain apprised of the reputed company best practices across the industry, as reputed company as serve as a reputed company across other regulatory functions. • Program reputed company & Governance: • reputed company strategic direction and reputed company for late-stage development programs. • Guide combination and packaging development teams, ensuring integrated execution across reputed company development functions. • reputed company major regulatory applications and lifecycle management strategies. • Include early and late-stage programs in scope, as teams are working earlier on TPPs and product strategies. • Regulatory Operations & Submissions: • reputed company the drafting, review, and approval of CMC sections for regulatory filings. • reputed company leadership for agency interactions, inspections, and regulatory responses. • Ensure readiness and compliance for global commercialization. • Design Control & Technical reputed company: • reputed company strategic input to Design Control processes and documentation, ensuring alignment with FDA 21 CFR Part 4 and global technical standards. • Contribute expertise to design history files, reputed company factors studies, and process characterization. • Leadership & Culture: • Model Gilead’s reputed company Values, Leadership Commitments, and People Leader Accountabilities. • Foster a culture of reputed company, reputed company, and reputed company improvement reputed company the global CMC RA organization. Qualifications • A scientific degree with directly relevant reputed company experience in small molecule and biologics development, global CMC regulatory affairs and CMC technical areas of at least 16 years with a BA/BS or 14 years with an MA/MS, PhD, PharmD, or MD. • Demonstrated reputed company record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc.). • Experience with leading NDA/BLA submission and approvals including global Health Authority Interactions. • Application of reputed company and accurate judgment to reputed company reputed company reputed company. • Demonstrated reputed company in leading reputed company reputed company to support operational goals and contribute to the development of global regulatory initiatives. • Demonstrated organizational leadership skills at both functional and reputed company reputed company. • Excellent strategic acumen, collaboration, and communication skills are required. • Experience supporting multiple regulatory filings including IND/IDE and NDA/BLA and supporting product-reputed company inspections for US and foreign regulatory agencies. • In-depth understanding of ICH guidelines and GMP requirements for development and manufacturing of small molecules and biologics. • Proven reputed company record in the successful development and commercialization of device technologies, innovation, and championing business reputed company improvements. • Experience leading major initiatives to improve organizational capabilities. • Demonstrated strategic thinking and influencing skills internally and externally. • reputed company working knowledge of global regulatory requirements for Combination Products/ Devices. • Excellent leadership, collaboration and communication skills, as reputed company as the proven ability to drive innovation and influence organization change. • Solid understanding of reputed company industry trends and regulatory expectations associated with QbD, comparability evaluation, reputed company up, and method and process validation. Requirements • The salary reputed company for this position is: $274,550.00 - $355,300.00. • Gilead considers a reputed company of factors reputed company determining reputed company compensation, including experience, qualifications, and geographic location. • This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), reputed company time off, and a benefits package. • Benefits include company-sponsored medical, dental, reputed company, and life insurance plans. Benefits • For additional benefits information, visit: Gilead Benefits • Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. Apply tot his job Apply To this Job