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Senior Director – Global Regulatory Affairs
Eli Lilly and CompanySenior Director leading US FDA regulatory strategy for Lilly’s life-changing medicines. Overseeing submissions, labeling, agency interactions, and regulatory teams.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in US regulatory strategy and compliance, with a strong focus on leading regulatory submissions and interactions with the FDA. Proven ability to manage teams, develop negotiation strategies, and ensure alignment with global regulatory plans.
Highest-signal resume keywords
US Regulatory StrategyRegulatory Submissions ManagementFDA Interaction LeadershipTeam Management and DevelopmentRisk Assessment and Mitigation
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
IND PreparationNDA PreparationBLA PreparationRegulatory ComplianceLabeling StrategyRegulatory IntelligenceDrug Development ProcessNegotiation StrategiesRegulatory Procedures KnowledgeQuality Systems Compliance
Soft Skills
Strong Communication SkillsAttention to DetailTeamwork and CollaborationNegotiation and InfluencePerformance Management
Certifications & Qualifications
PhDMDPharmD
Industry Keywords
Regulatory AffairsDrug DevelopmentFDA GuidelinesRegulatory GovernancePromotional Claims Strategy
About the role
Key responsibilities & impact- Establish and execute the US regulatory strategy and plan for assigned products
- Ensure local plans align with global regulatory strategy and Global Regulatory Plans
- Lead oversight of regulatory submissions, approvals, and labeling for assigned US products
- Prepare, review, and deliver INDs, NDAs, BLAs, supplements, and responses
- Lead and participate in FDA meetings and interactions
- Develop briefing documents and agency negotiation strategies
- Define scientific priorities and key deliverables for assigned programs
- Lead labeling strategy and negotiations with FDA under GRL direction
- Interpret evolving US regulatory guidelines and communicate impacts
- Ensure compliance with US regulations and internal quality systems
- Own regulatory activities for assigned marketed products and manage alliance/CRO relationships
- Guide promotional claims and strategy with Global Marketing and US Brand Teams
- Partner with the GRL on Global Regulatory Plan development and implementation
- Share regulatory intelligence, FDA feedback, and submission status
- Anticipate regulatory risks and propose mitigation strategies
- Participate in regulatory governance and information-sharing forums
- Propose process improvements and lead cross-functional regulatory projects
- Recruit, manage, train, develop, coach, and performance-manage direct reports
- Monitor resources and workload, motivate employees, and manage performance
Requirements
What you’ll need- Advanced scientific degree (PhD, MD, or PharmD) with at least 5 years of relevant industry-related experience in regulatory affairs and/or drug development, OR bachelor’s degree with at least 10 years of relevant industry-related experience
- Knowledge of local/regional regulatory procedures and practices
- Awareness of evolving regulatory reform initiatives preferred
- Knowledge of the integrated drug development process and regulatory/business strategies
- Ability to find solutions and alternatives through teamwork
- Ability to assess and manage risk in a highly regulated environment
- Strong written, spoken, and presentation communication
- Negotiation and influence skills
- Attention to detail
- 8 years of industry-related regulatory affairs and/or drug development experience preferred
- Ability to recruit, manage, train, develop, coach, and supervise a complementary team
Benefits
Comp & perks- Company bonus based in part on company and individual performance
- 401(k)
- Pension
- Vacation benefits
- Medical benefits
- Dental benefits
- Vision benefits
- Prescription drug benefits
- Healthcare flexible spending accounts
- Dependent day care flexible spending accounts
- Life insurance and death benefits
- Time off and leave of absence benefits
- Well-being benefits
- Employee assistance program
- Fitness benefits
- Employee clubs and activities
- Employee resource groups (ERGs)
- Disability accommodation support during the application process