Sr. Director - Global Regulatory Lead - Neuroscience/Immunology 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

Advanced knowledge in regulatory affairs, scientific expertise, and therapeutic areas (Neuroscience/Immunology)
Experience leading global regulatory strategies from portfolio entry to end of lifecycle
Ability to form and lead a highly effective Global Regulatory Team (including GRA central functions, GRA-CMC, GRA-Devices, and regional regulatory scientists)
Expertise in creating and maintaining Regulatory Strategy Documents (RSD)
Strong integration skills to align local/regional plans with Global Brand Development (GBD)/global program team priorities (value proposition, workflow, product labeling, risk management, issues management)
Capability to represent GRA on GBD/global program teams and at stakeholder/governance meetings
Experience leading US and Canada submissions and agency interactions for preclinical/early clinical programs
Knowledge of regulatory policies, precedents, trends, emerging regulatory science, and health authority interactions
Ability to monitor external environment, product-specific regulator advice, and public information (e.g., Advisory Committees)

Responsibilities

Develop, update, and execute innovative global regulatory strategies for assigned products/therapeutic areas to meet business objectives and regional requirements
Lead the Global Regulatory Team, leveraging expertise to initiate and maintain RSD(s)
Obtain input from global regulatory team members to develop strategies supporting product development, registration, and lifecycle maintenance (from Candidate Selection to End of Product Lifecycle, including NILEX)
Implement innovative approaches, acceleration strategies, identify and communicate regulatory risks
Provide input for and attend key regulatory agency meetings impacting global product strategy
Enable discussion of RSD and regulatory issues at Regulatory Strategy Forum with Global Regulatory Team
Serve as primary GRA interface with GBD/global program team, representing regional plans and including experts as needed
Continually expand therapeutic area knowledge and monitor/assess impact of relevant regulatory developments

Skills

Regulatory Strategy

Global Regulatory Affairs

Therapeutic Area Management

Neuroscience

Immunology

Regulatory Team Leadership

Risk Management

Product Labeling

CMC Regulations

Device Regulations

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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