Senior Director Global Regulatory Lead (Late Phase) - Diabetes and Obesity at Eli Lilly and Company

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Healthcare, BiotechnologyIndustries

Requirements

Develop, update, and implement innovative global regulatory strategies for products in the diabetes and obesity therapeutic area from portfolio entry to end of lifecycle
Serve as the accountable decision maker for the development and execution of global regulatory strategies to meet global business objectives and regional/local affiliate requirements
Build and lead the Global Regulatory Team, including GRA central functions, GRA-CMC, GRA-Devices, and regional regulatory scientists
Create and maintain the Regulatory Strategy Document (RSD) and ensure alignment of local plans with Global Brand Development (GBD)/global program team priorities, including value proposition, workflow, product labeling, risk management, and issues management
Act as the primary interface representing GRA on GBD/global program teams to provide global input into development plans, solutions to barriers, and risk management
Represent regional regulatory plans to GBD/global program teams and at stakeholder/governance meetings, including GRA functional and regional experts as needed
Acquire input from global regulatory team members to develop strategies supporting product (including delivery devices and medical devices) development, registration, and lifecycle maintenance
Integrate regulatory strategy into development team plans from Candidate Selection to End of Product Lifecycle (including NILEX), driving acceleration strategies and communicating risks
Use team expertise, scientific knowledge, regulatory policies, precedents, trends, emerging science, external environment, regulator advice, and public information to develop robust strategies
Provide input for and attend key regulatory agency meetings impacting global product strategy or brand
Enable discussion of RSD and regulatory issues at the Regulatory Strategy Forum with the Global Regulatory Team
Continually expand therapeutic area knowledge and monitor global regulations, guidance, competitive approvals, and regulatory environment
Ensure strategic messaging and content of global regulatory submission documents and provide regulatory direction for core data sheet and claims mapping

Responsibilities

Lead Global Regulatory Team in developing and maintaining RSD(s) for assigned programs
Identify and effectively communicate regulatory risks
Develop and implement innovative approaches and solutions to regulatory challenges
Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment
Monitor upcoming and recent approvals of competitive development programs/plans

Skills

Regulatory Strategy

Global Regulatory Affairs

Therapeutic Area Management

Team Leadership

Risk Management

Product Labeling

Stakeholder Management

CMC Regulations

Device Regulations

Portfolio Management

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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