Eli Lilly and Company is hiring for the position of Regulatory Writing Capability Lead in Bengaluru, Karnataka. This is a full-time opportunity focused on regulatory writing, clinical study submission and approval capabilities, strategic development, operational excellence and cross-functional leadership.
The role involves leading regulatory writing and study-related capabilities within the Global Supply Chain (GSC) organization. The selected professional will work closely with clinical development teams, study leads and other stakeholders to strengthen regulatory writing practices, study strategies, submission readiness and process excellence.
The position also includes responsibility for capability development, industry engagement and, where applicable, people management and development.
Lilly Recruitment 2026 – Job Highlights
| Particular | Details |
|---|---|
| Company | Eli Lilly and Company |
| Position | Regulatory Writing Capability Lead |
| Location | Bengaluru, Karnataka, India |
| Employment Type | Full-time |
| Job Requisition ID | R-111029 |
| Functional Area | Regulatory Writing / Study Submission & Approval |
| Application Mode | Online |
| Application Deadline | September 16, 2026 |
About Lilly
Eli Lilly and Company is a global healthcare organization headquartered in Indianapolis, Indiana. The company works on the discovery and delivery of medicines while supporting efforts to improve healthcare and disease management.
The Regulatory Writing Capability Lead role forms part of Lilly’s broader capabilities supporting clinical development, regulatory writing and study submission activities.
About the Regulatory Writing Capability Lead Role
The Regulatory Writing Capability Lead is responsible for strengthening regulatory writing and study submission and approval capabilities within GSC.
The position requires an in-depth understanding of regulatory writing techniques, study development environments, regulatory expectations and industry practices. The role also involves identifying emerging trends and using internal and external insights to help shape regulatory writing, content and study submission strategies.
In addition, the Capability Lead will work with clinical development experts and study teams to improve study design, planning, execution and regulatory readiness.
Key Responsibilities
Regulatory Writing and Study Submission Capability
- Lead regulatory writing and study submission/approval capabilities within GSC.
- Develop and maintain expertise in regulatory writing techniques and practices.
- Monitor the regulatory environment, including relevant guidance, advisory committees and approval forums.
- Track pharmaceutical industry submissions and approvals to understand evolving practices.
- Use internal and external insights to identify emerging trends and regulatory requirements.
- Contribute to the development and refinement of Lilly and GSC regulatory writing, content and study submission strategies.
- Lead global onboarding and training programs related to design and study development.
- Build strong relationships with clinical development experts across Lilly.
- Advise asset teams on study design, strategy, planning, execution and applicable best practices.
- Serve as a subject matter expert for core business processes, procedures and applicable documents.
- Act as process owner for relevant regulatory writing and study processes.
- Lead and manage functional initiatives.
- Represent GSC in due diligence activities when required.
Clinical Design and Study Capability Excellence
- Represent GSC in clinical design and study-related initiatives.
- Work with clinical study design counterparts and GSC study leads to strengthen submission and approval capabilities.
- Support global operational excellence in study design and strategy.
- Help develop optimized documents that communicate focused messages and align with current agency and competitor standards.
- Monitor capability performance throughout study design, regulatory response and implementation activities.
- Work closely with study teams to identify opportunities for continuous process improvement.
- Define and monitor relevant performance metrics.
- Collect and analyze key capability data and take appropriate improvement actions.
- Collaborate across the wider GSC Regulatory Capability organization.
External Industry Engagement
- Represent Lilly in relevant external industry forums and professional organizations.
- Participate in organizations and forums such as PhRMA, EFPIA, DIA and TransCelerate, as applicable.
- Contribute to the development of industry standards through collaboration with external organizations, professional societies, regulators and vendors.
- Participate in external initiatives designed to build trust and constructive relationships with industry stakeholders.
- Bring relevant external perspectives and developments into Lilly’s regulatory capability activities.
People Management and Development
Where applicable, the role may include leadership and development responsibilities for a team of regulatory writing and study development experts.
Responsibilities can include:
- Lead a team of subject matter experts.
- Recruit, develop and retain a strategically capable workforce.
- Build an agile organization that can respond to changing portfolio requirements.
- Foster a culture aligned with Lilly’s values, including inclusion, innovation, integrity, excellence and respect.
- Develop team expertise across drug development, therapeutic-area science, strategic thinking and project management.
- Provide input into employee development, talent assessment and succession planning.
- Support judgment-based decision-making across the organization.
- Provide guidance, training and supervision to team members.
- Manage workloads and monitor project timelines and quality.
- Communicate priorities and expectations to direct reports.
- Provide technical guidance and support when required.
- Review work products and participate in writing team meetings to assess performance and development needs.
- Ensure team members follow applicable company policies, procedures and regulations.
- Participate in GSC functional recruitment activities.
Educational Qualification and Eligibility
The supplied job information does not specify a particular educational qualification, degree or minimum years of experience for the Regulatory Writing Capability Lead position.
Candidates should therefore review the official Lilly application listing carefully for any additional eligibility requirements displayed during the application process.
Required Skills and Professional Expertise
The responsibilities indicate that candidates should have strong expertise in areas such as:
- Regulatory writing
- Clinical study development
- Study submission and approval processes
- Regulatory strategy
- Clinical development
- Study design and planning
- Regulatory requirements and guidance
- Pharmaceutical development processes
- Process ownership
- Capability development
- Operational excellence
- Data and metrics analysis
- Cross-functional leadership
- Project management
- Strategic thinking
- Training and capability building
- Stakeholder management
- External industry engagement
Strong communication, leadership and collaboration capabilities are particularly relevant because the position involves interaction with clinical development teams, study leads, external organizations and senior stakeholders.
Work Location and Employment Type
Location: Bengaluru, Karnataka, India
Employment Type: Full-time
The supplied vacancy identifies Bengaluru as the work location and lists the position as full-time.
Career Opportunity
The Regulatory Writing Capability Lead position provides an opportunity to work at the intersection of regulatory writing, clinical development, study strategy and organizational capability building.
The role involves both strategic and operational responsibilities, including improving regulatory writing processes, supporting study teams, developing organizational expertise, monitoring industry developments and contributing to external industry initiatives.
For professionals with relevant regulatory writing and clinical development expertise, the position offers exposure to global regulatory and study-related activities.
Salary / CTC
The supplied job posting does not specify a salary range or CTC for this position. Candidates should confirm compensation details through the official recruitment process.
Selection Process
The detailed selection process has not been specified in the supplied vacancy information. Candidates should follow the instructions provided through Lilly’s official application process.
How to Apply
Interested and eligible candidates can apply online for the Regulatory Writing Capability Lead position in Bengaluru.
Position: Regulatory Writing Capability Lead
Job Requisition ID: R-111029
Location: Bengaluru, Karnataka, India
Employment Type: Full-time
Application Deadline: September 16, 2026
Candidates should submit their application before the stated deadline and review the complete job requirements before applying.
Workplace Accommodation
Lilly states that it supports individuals with disabilities and provides accommodation during the application process where required.
Candidates who need an accommodation to submit a resume or complete the application can use Lilly’s workplace accommodation request process.
Lilly Workplace Accommodation Request
Important Details Before Applying
- Company: Eli Lilly and Company
- Position: Regulatory Writing Capability Lead
- Location: Bengaluru, Karnataka, India
- Employment Type: Full-time
- Job Requisition ID: R-111029
- Application Mode: Online
- Last Date to Apply: September 16, 2026
- Primary Area: Regulatory Writing
- Key Functions: Study submission, approval capabilities, clinical study development and regulatory strategy
- Leadership Areas: Capability development, process ownership, cross-functional collaboration and people management where applicable
Important Note
The supplied vacancy does not state a specific degree or minimum experience requirement. Candidates should check the official Lilly careers listing for the latest eligibility information before applying.
Recruitment timelines, vacancy status and other employment conditions may change. Applicants should rely on the official Lilly application portal for the latest information.
Frequently Asked Questions
1. What position is Lilly hiring for?
Lilly is hiring for a Regulatory Writing Capability Lead position.
2. Where is this position located?
The job is based in Bengaluru, Karnataka, India.
3. What is the employment type?
The position is listed as a full-time opportunity.
4. What are the main responsibilities of the Regulatory Writing Capability Lead?
The role includes regulatory writing capability development, study submission and approval support, clinical study strategy, process ownership, capability improvement, metrics analysis and cross-functional collaboration.
5. Does the role involve people management?
People management and development responsibilities are included as applicable, including team leadership, recruitment, employee development, workload management and technical guidance.
6. Which external industry organizations may the role engage with?
The job description mentions external forums and organizations such as PhRMA, EFPIA, DIA and TransCelerate.
7. What is the last date to apply?
The listed application deadline is September 16, 2026.
8. What is the job requisition ID?
The job requisition ID is R-111029.
