Gilead Sciences
Associate Director, Regulatory Affairs - Virology
Gilead Sciences, Parsippany, New Jersey, United States
Overview
Associate Director, Regulatory Affairs - Virology at Gilead Sciences. The role involves acting as the Regional Regulatory Lead on complex virology products, defining regulatory strategy and plans, leading regulatory submission teams, and guiding labeling, packaging, and regulatory documentation to ensure compliant submissions across assigned products and markets. Position may be based in Foster City, CA or Parsippany, NJ. Responsibilities
Represent Regulatory Affairs and provide strategic guidance on regulatory submissions and cross-functional teams. Lead regulatory strategy development for multiple products or projects and serve as Global Regulatory Lead for early-stage or other programs as applicable. Lead Regulatory Submission Teams and cross-functional core/sub-teams; act as Gilead contact to regulatory authorities. Oversee preparation and maintenance of regulatory submissions, labeling, and packaging in accordance with product licenses and market requirements. Guide and advise colleagues to ensure thorough and compliant completion of regulatory activities. Lead ad hoc or special projects to advance Regulatory Affairs capabilities. Provide matrix management and leadership to project teams; contribute to resource planning and budgeting; ensure compliance with practices and regulatory requirements. Qualifications
U.S. Education & Experience PharmD/PhD with 2+ years’ relevant experience. MA/MS/MBA with 8+ years’ relevant experience. BA/BS with 10+ years’ relevant experience. Significant regulatory, quality, or compliance experience in biopharma; track record of directing regulatory strategy for products or markets. Experience negotiating with regulatory authorities and collaborating with cross-functional teams in drug development. Knowledge & Other Requirements In-depth knowledge of FDA, EMA, and ICH requirements; understanding regional regulatory differences. Awareness of global/regional regulatory trends and ability to apply them to deliverables. Strong regulatory, analytical, and organizational skills; ability to lead without direct authority and influence programs. Excellent interpersonal, negotiation, and conflict-resolution skills; strong communication abilities. Willingness and ability to travel as needed. Salary & Benefits
Salary ranges (before bonuses and incentives): Bay Area: $182,070.00 – $235,620.00; Other US Locations: $165,495.00 – $214,170.00. Details on discretionary bonuses, stock-based incentives, PTO, and benefits are provided by the company. Benefits include medical, dental, vision, and life insurance plans. For more information, see the company compensation, benefits and wellbeing resources. Location
Foster City, CA or Parsippany, NJ, with possible cross-site assignments as needed. EEO & Employment Notices
Gilead Sciences is an equal opportunity employer. Employment decisions are based on qualifications and business needs. Reasonable accommodations are available for applicants with disabilities. See company policy for more details.
#J-18808-Ljbffr
Associate Director, Regulatory Affairs - Virology at Gilead Sciences. The role involves acting as the Regional Regulatory Lead on complex virology products, defining regulatory strategy and plans, leading regulatory submission teams, and guiding labeling, packaging, and regulatory documentation to ensure compliant submissions across assigned products and markets. Position may be based in Foster City, CA or Parsippany, NJ. Responsibilities
Represent Regulatory Affairs and provide strategic guidance on regulatory submissions and cross-functional teams. Lead regulatory strategy development for multiple products or projects and serve as Global Regulatory Lead for early-stage or other programs as applicable. Lead Regulatory Submission Teams and cross-functional core/sub-teams; act as Gilead contact to regulatory authorities. Oversee preparation and maintenance of regulatory submissions, labeling, and packaging in accordance with product licenses and market requirements. Guide and advise colleagues to ensure thorough and compliant completion of regulatory activities. Lead ad hoc or special projects to advance Regulatory Affairs capabilities. Provide matrix management and leadership to project teams; contribute to resource planning and budgeting; ensure compliance with practices and regulatory requirements. Qualifications
U.S. Education & Experience PharmD/PhD with 2+ years’ relevant experience. MA/MS/MBA with 8+ years’ relevant experience. BA/BS with 10+ years’ relevant experience. Significant regulatory, quality, or compliance experience in biopharma; track record of directing regulatory strategy for products or markets. Experience negotiating with regulatory authorities and collaborating with cross-functional teams in drug development. Knowledge & Other Requirements In-depth knowledge of FDA, EMA, and ICH requirements; understanding regional regulatory differences. Awareness of global/regional regulatory trends and ability to apply them to deliverables. Strong regulatory, analytical, and organizational skills; ability to lead without direct authority and influence programs. Excellent interpersonal, negotiation, and conflict-resolution skills; strong communication abilities. Willingness and ability to travel as needed. Salary & Benefits
Salary ranges (before bonuses and incentives): Bay Area: $182,070.00 – $235,620.00; Other US Locations: $165,495.00 – $214,170.00. Details on discretionary bonuses, stock-based incentives, PTO, and benefits are provided by the company. Benefits include medical, dental, vision, and life insurance plans. For more information, see the company compensation, benefits and wellbeing resources. Location
Foster City, CA or Parsippany, NJ, with possible cross-site assignments as needed. EEO & Employment Notices
Gilead Sciences is an equal opportunity employer. Employment decisions are based on qualifications and business needs. Reasonable accommodations are available for applicants with disabilities. See company policy for more details.
#J-18808-Ljbffr