Associate Director-Regional Regulatory Associate

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

People Management

• Recruit, develop, and retain a diverse and highly capable workforce  
• Ensure robust individual training plans and timely completion of required training for direct reports.  
• Support and enable talent identification and career development that reflects an end-to-end mindset and demonstrates judgement-based decision making
• Ensure regulatory competencies are present and continuously improving
• Manage workload based on portfolio prioritization, regional requirements, and individual level of expertise, and address implications to overall resource management and strategies.
• Support and encourage a culture of innovation and model inclusivity to ensure diverse voices and ideas are heard and considered

Regulatory Delivery

• Demonstrate strong business acumen, problem-solving skills, and learning agility to help teams plan for contingencies, and adjust to change
• Manage global cross-functional communication and issue escalations to ensure alignment on delivery and execution.
• Understand regulations and how they apply to the submission process and use this to provide technical leadership to the team
• Utilize regulatory and process knowledge to drive decision-making
• Ensure strategies for enhancing focus on the customer exist and are implemented.
• Actively partner with upstream work units to ensure process alignment and best practices.
• Develop, implement, and monitor metrics to ensure continuous improvement and compliance.
• Partner with quality in both process improvements and deviation management.
• Monitor regulation/external environment as appropriate
• In partnership with other RDE site leaders, enable and optimize capabilities and standardization for all Clinical regulatory submission processes
• Partner with RDE site leadership on site resource utilization, capacity management and issue resolution
• Serve as the lead interface with Quality for all RDE deviations, inspections, and audits
• Working with supervisor provide a point of contact for planning and partnering for submission development for any in-license/out-license compounds or wholly owned subsidiaries.
• Ensure Regulatory has assigned Submission and Approval Expert Network (SAEN) representative for Regulatory – Clinical
• Ensure overall performance metrics are in place across the RDE sites and globally

Effective Management

• Align resources based on portfolio prioritization while demonstrating flexibility across business units and geographies
• Ensure a compliance culture and state of inspection readiness
• Model judgement-based decision making to navigate compliance and quality requirements
• Responsible for continuous improvement and shared learning and collaborates with process owners in the spirit of streamlining, efficiency, and effectiveness of submission management
• Provide resources for area strategic initiatives and process improvements.
• Proactively seeks feedback on team’s performance for continuous learning
• Ensure external collaboration partners are managed consistently, aligned sourcing, procurement, and quality business processes

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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