Senior Director Global Regulatory Affairs - Global Regulatory Scientist
Overview
Lead regulatory science and FDA execution for US products driving high quality submissions. Own strategy alignment and cross-functional collaboration. Differentiate as senior leader shaping future regulatory direction.
What You'll Do57
- 1Advise GRL on global regulatory strategy execution for US products ensuring scientific quality and alignment with GRP
- 2Oversee preparation and delivery of IND NDA BLA submissions and related regulatory content
- 3Lead FDA meetings and negotiate labeling strategies with cross-functional teams
- 4Define scientific priorities and key deliverables for assigned programs through regulatory input
- 5Contribute to governance committees on regulatory strategy decisions impacting US operations
- 6Develop labeling strategy using regulatory expertise and market intelligence
- 7Lead negotiations with FDA under GRL direction influencing commercial labeling outcomes
- 8Ensure compliance with US regulations and internal quality systems for assigned products
- 9Provide regulatory oversight for submission-related deliverables and quality assurance
- 10Manage regulatory evaluations of business opportunities and alliance/CRO relationships
- 11Set direction with Global Marketing for promotional claims development and approval
- 12Partner with GRL to implement robust regulatory sequencing strategies
- 13Assess GRS performance through feedback processes and partnership development
- 14Serve as interface point for TA when designated providing strategic counsel to GRL
- 15Collaborate with global regulatory leads to solve development and regulatory issues
- 16Propose continuous improvement projects to enhance regulatory workflow efficiency
- 17Recruit, develop, and retain talent managing direct reports and resources
- 18Motivate team by identifying employee importance and rewarding contributions
- 19Select and retire talent based on qualifications and potential for leadership roles
- 20Demonstrate knowledge of local/regional regulatory procedures and evolving reforms
- 21Apply integrated drug development process expertise to regulatory strategy
- 22Evaluate risk management in highly regulated environments
- 23Communicate regulatory impacts to GRL and cross-functional teams
- 24Maintain strong written and spoken communication skills
- 25Negotiate and influence stakeholders to achieve positive business outcomes
- 26Assess and manage regulatory risks while proposing mitigation strategies
- 27Partner with Global Marketing for regulatory aspects of promotional claims
- 28Participate in forums sharing regulatory intelligence across organizations
- 29Ensure alignment between GRS activities and global regulatory strategy
- 30Advocate for information sharing between GRS and GRL organizations
- 31Propose proactive regulatory intelligence and strategic improvements
- 32Lead regulatory governance forums and cross-functional governance discussions
- 33Assess organizational performance through feedback processes
- 34Act as interface point for TA providing strategic counsel to GRL
- 35Solve development and regulatory issues impacting submissions and registrations
- 36Propose process simplification projects to increase productivity
- 37Lead regulatory function on non-product related initiatives
- 38Promote innovation and continuous improvement culture
- 39Model Team Lilly behaviors including inclusion and excellence
- 40Constructively challenge teams to achieve optimal solutions
- 41Recruit, manage, train, and develop talent with high expectations
- 42Monitor workload to ensure balanced efficiency and maximize capacity
- 43Identify employee motivations and recognize important contributions
- 44Set high expectations for value creation and performance
- 45Minimum Qualification Requirements: Advanced scientific degree with 5+ years or bachelor's with 10+ years relevant experience
- 46Advanced scientific degree with 5+ years or bachelor's with 10+ years relevant experience
- 47Knowledge of local/regional regulatory procedures
- 48Awareness of evolving regulatory reform initiatives
- 49Demonstrated ability to find solutions through teamwork
- 50Strong written, spoken, and presentation communication skills
- 51Negotiation and influence skills
- 52Attention to detail
- 53Industry-related experience for 8 years preferred
- 54May be named as lead for lower-complexity assets
- 55Accommodation request form available for application
- 56EEO Employer commitment
- 57Employee resource groups available
Requirements11
- 1Advanced scientific degree with 5+ years or bachelor's with 10+ years relevant experience
- 2Knowledge of local/regional regulatory procedures
- 3Awareness of evolving regulatory reform initiatives
- 4Demonstrated ability to find solutions through teamwork
- 5Strong written, spoken, and presentation communication skills
- 6Negotiation and influence skills
- 7Attention to detail
- 8Industry-related experience for 8 years preferred
- 9Accommodation request form available for application
- 10EEO Employer commitment
- 11Employee resource groups available
Salary Insight
$170 - $249k per year
Location
Required Skills
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