Manager, Regulatory Delivery Excellence

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.

Purpose

The purpose of the Manager of Regulatory Delivery Excellence (RDE) role is to manage the operations and deliverables of registration management work performed by the RDE Regulatory Associates and Submission Publishers from candidate selection to end of product lifecycle. This includes appropriate resourcing, staff development and performance management, training, and process improvement. The manager reaches out to business partners to ensure alignment on registration management process requirements and expectations. The manager engages with business systems and operations for system upgrades and issues impacting publishing. The manager directly manages selected regulatory processes.

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.

Develop People

• Ensure individuals have performance management and development plans.
• Ensure individuals comply with PM expectations.
• Provide individuals with training, challenging assignments, feedback and coaching.
• Ensure salary/merit pay administration.
  
  
  

Strategy

• Ensure registration management deliverables are aligned with corporate and regulatory directives.
• Provide leadership in the development and implementation of business change initiatives.
• Participate in business planning efforts.
• 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.
• Explore external sourcing when business needs arise.
  
  
  

Process Improvement

• Develop, implement, and monitor metrics to ensure continuous improvement and compliance.
• Initiate/monitor improvement projects.
• Actively partner with business systems and operations to implement successful upgrades and issue resolution.
• Partner with quality in both process improvements and deviation management.
  
  
  

Staffing

• Ensure appropriate capacity planning for the area.
• Responsible for appropriate product assignments.
• Monitor workload/project balance and make adjustments as necessary.
• Recruit, interview, and hire.
• Provide resources for area strategic initiatives and process improvements.
  
  
  

Fosters Communication and Customer Service

• Promotes proactive management of daily operations while emphasizing the need for clear regular communications with customers.
• Oversee development and implementation of processes for measuring customer satisfaction.
• Reaches out to business partners for continuous learning
  
  
  

Provides Technical Leadership

• Understand regulations and how they apply to the submission process.
• Provide technical leadership for the team.
• Consult with staff on regulatory/submission process questions.
• Personally accountable for selected regulatory processes and/or documents.
• Monitor regulation/external environment as appropriate
  
  
  

Continues Personal Development

• Develop and implement personal improvement strategies.
  
  
  

Minimum Qualification Requirements

• A Post graduate or higher degree in a technical discipline such as chemistry, biology, pharmacy or equivalent demonstrated industry experience
• Technical understanding of regulatory and regulatory processes
• Prior supervisory experience of larger teams (> 5) with global submission responsibilities in various submission types
• Prior experience with eCTD and Non eCTD global submissions and ICH compliance requirements
• Excellent communication skills (verbal and written)
• Strong interpersonal skills, including experience coaching and mentoring
• Strong organizational skills
• Conflict management/conflict resolution skills
  
  
  

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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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