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Eli Lilly And Company
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Associate Director-Regional Regulatory Associate

Associate Director-Regional Regulatory Associate

Eli Lilly And Company

5 - 10 years

25 - 35 Lacs

bengaluru

Posted:3 weeks ago| Platform:

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Skills Required

procurement capacity management career development resource utilization compliance healthcare issue resolution management resource management continuous improvement

Work Mode

Work from Office

Job Type

Full Time

Job Description

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

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Eli Lilly And Company

Pharmaceutical Manufacturing

Indianapolis Indiana

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Associate Director-Regional Regulatory Associate