Manager, Regulatory Affairs

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $133.2k - $172.4k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

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Gilead Sciences

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1987

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

Gilead Sciences is a leading biopharmaceutical company that focuses on discovering, developing, and delivering innovative therapeutics for patients with life-threatening diseases. The company is highly recognized for its contributions in virology, particularly HIV and hepatitis, and is actively expanding its therapeutic reach into fields like oncology and inflammation. Gilead has a strong pipeline of medicines, with over 25 products available globally and 50 clinical programs. Known for its commitment to health equity, the company also actively funds HIV research and causes. Gilead's dedication to scientific innovation and health equity aims to tackle the world's most pressing health challenges, improving patient lives globally.

📋 Description

• Lead operational programs supporting promotional material review, claims and reference governance, FDA submission readiness, training, business process optimization, and performance reporting • Maintain and evolve Kite's Claims, References, and Annotation programs • Partner with Medical, Legal, Regulatory, Commercial, and agency stakeholders on claims documentation and maintenance • Monitor compliance with internal reference formatting standards, submission requirements, and approved claims usage • Improve claim management processes, reference libraries, reusable text assets, and documentation • Develop, maintain, and deliver PRC Operations and Regulatory Affairs Advertising & Promotion training materials • Create training decks, onboarding materials, process documentation, and business guidance resources • Facilitate training for business owners, agency partners, reviewers, and operational stakeholders • Own and maintain PRC Operations playbooks, job aids, standard operating procedures, process guides, and submission guidelines • Coordinate cross-functional reviews and updates to process documentation • Support inspection readiness and audit preparedness through documentation governance • Schedule, prepare, and quality check FDA submissions • Manage submission timelines with cross-functional teams • Enhance, maintain, and analyze PRC Operations metrics and dashboards • Generate routine reporting for leadership and executive stakeholders • Identify trends and recommend process improvements using data-driven insights • Evaluate and advance AI, automation, and digital solutions for PRC Operations • Partner with Information Technology, Regulatory Affairs, Commercial Operations, and external vendors on automation initiatives • Support implementation and optimization of Veeva PromoMats, eCTD capabilities, reporting solutions, and future technology platforms • Lead cross-functional operational projects and serve as a trusted advisor to key stakeholders • Foster continuous improvement, collaboration, accountability, and innovation

🎯 Requirements

• Bachelor's Degree and 6+ years of experience in Regulatory Affairs, Promotional Review Operations, Commercial Operations, Medical Affairs Operations, Regulatory Business Operations, or related pharmaceutical/biotechnology functions, or Master's Degree and 4+ years of experience in those fields • Experience supporting Promotional Review Committee (PRC), Medical Review Committee (MRC), or comparable review processes • Strong understanding of FDA advertising and promotion requirements • Experience managing Form FDA 2253 and FDA APLB/OPDP submissions • Experience with Veeva PromoMats/MedDocs and promotional material lifecycle management • Expertise in claims management, reference governance, and annotation standards • Experience developing training curricula, playbooks, process documents, and operational guidance materials • Strong analytical capabilities and experience developing operational metrics and dashboards • Knowledge of AI, automation technologies, workflow optimization, and digital transformation initiatives • Project management and stakeholder management skills within a highly matrixed environment • Ability to be flexible and adaptable to change • Strong interpersonal skills and understanding of team dynamics • Excellent written, verbal, presentation, and organizational skills

🏖️ Benefits

• Discretionary annual bonus eligibility • Discretionary stock-based long-term incentives eligibility may vary based on role • Paid time off • Company-sponsored medical insurance • Company-sponsored dental insurance • Company-sponsored vision insurance • Company-sponsored life insurance