Associate Director, Regulatory Affairs - Virology

Role Summary

Associate Director, Global Regulatory Affairs in the virology therapeutic area. Lead regulatory strategy, plans, and objectives for assigned products or projects; may act as Global Regulatory Lead for early-stage programs; oversee regulatory submissions, labeling, and packaging; lead Regulatory Submission Teams and cross-functional teams; represent regulatory authorities to regulators as needed.

Responsibilities

• Represent Gilead in negotiations with regulatory authorities as needed.
• Represent Regulatory Affairs as Regional or Global Regulatory Lead on cross-functional submission teams; provide strategic guidance to regulatory and cross-functional leaders.
• Participate in or supervise sub-teams across study management, clinical, nonclinical, biomarkers, or assign to colleagues and guide their participation.
• Define regulatory strategy for multiple Gilead products or projects.
• Identify regulatory risks/issues and develop mitigation or contingency plans.
• Oversee preparation, compilation, and timely filing of regulatory submissions requiring cross-functional interactions (e.g., requests, INDs, amendments, DSURs, IB updates).
• Oversee and approve regulatory documents, including meeting requests and Module 1 documents for original INDs.
• Oversee and guide labeling, packaging, and information updates in accordance with product licenses.
• Critically review documents for regulatory submissions.
• Provide matrix management and leadership to project teams; contribute to resource and budget planning and tracking.
• Ensure work complies with established practices, policies, 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, compliance, or related biopharma experience.
  • Proven track record in setting and directing regulatory strategy for multiple products or markets; experience negotiating with regulators.
  • Experience participating in cross-functional projects related to clinical trials or drug development.
  • Demonstrated ability to delegate and manage others in a matrix environment.
  • Experience with one or more Gilead therapeutic areas and varying stages of development is preferred.

Knowledge

• Deep understanding of FDA and EMA regulatory requirements and ICH standards; awareness of regional regulatory requirements.
• Knowledge of global/regional regulatory trends in biopharmaceuticals and ability to apply this to team deliverables.
• Advanced regulatory and business knowledge with strong analytical abilities; ability to advise on regulatory implications of complex data.
• Strong knowledge of health authorities and effective HA interactions.
• Ability to represent Gilead to regulatory authorities in negotiations.
• Thorough knowledge of the drug development process from early research to post-marketing.
• Strong leadership presence; ability to influence without authority; strong interpersonal, communication, organizational, negotiation, and conflict-resolution skills.
• Willingness and ability to travel when needed.

Education

• Not specified beyond degree requirements in qualifications.