Regulatory Affairs Manager specializing in food industry compliance across US/North America. Leading regulatory strategies and communication for food ingredients and products.
EC
Hybrid Associate Vice President – Head of Digital Strategy and Innovation
Posted 2 months ago
About the role
- Lead digital strategy and innovation at Lilly focusing on AI and analytics in Global Regulatory Affairs. Drive transformation initiatives and operational excellence for regulatory submissions.
Responsibilities
- Lead the digital transformation and automation agenda across Global Regulatory Affairs
- Drive implementation of AI/ML applications, advanced analytics and digital capabilities that accelerate regulatory delivery
- Establish performance metrics and real-time dashboards that track organizational effectiveness and demonstrate business impact
- Translate strategic digital and operational visions into tactical execution plans
- Drive end-to-end implementation of approved digital and operational initiatives across GRA
- Develop and implement comprehensive change-management plans including communication strategies and training programs
- Monitor external environment for novel digital trends, tools, and methods
Requirements
- Experience in pharmaceutical industry with significant focus on digital transformation, technology implementation, data analytics, and/or operational excellence
- Deep expertise in digital transformation, AI/ML applications, data analytics, and/or operational excellence in pharmaceutical or highly regulated industry
- Demonstrated ability to lead and drive technology-driven and operational improvement initiatives in complex organizations
- Strong understanding of pharmaceutical drug development process and regulatory affairs operations
- Experience with regulatory information management systems (e.g., Veeva RIM), data governance, and analytics platforms
- Leadership experience developing/leading teams
- Experience in regulatory affairs or quality systems beneficial
- Proven ability to translate strategic visions into tactical execution plans with measurable results
- Commitment to fostering inclusive, high-performing team culture that values innovation and innovative ideas
- Bachelor's degree in IT, data science, engineering, life-sciences, or related field; advanced degree preferred
Benefits
- eligibility to participate in a company-sponsored 401(k)
- pension
- vacation benefits
- eligibility for medical, dental, vision and prescription drug benefits
- flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
- life insurance and death benefits
- certain time off and leave of absence benefits
- well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
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