Post Approval Scientist for Solid Oral Products 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

PharmaceuticalsIndustries

Requirements

B.S. degree in a science, engineering, or a related field (advanced degree preferred). Fields of study include Chemistry, Pharmaceutics, Chemical Engineering, Analytical Sciences, Biology, or similar
5+ years of Regulatory CMC experience and/or equivalent (such as time spent in supporting CMC functions for commercialization of solid oral products with regulatory submission experience)

Responsibilities

Deep technical knowledge of solid oral products CMC science and manufacturing processes
Knowledge of global CMC regulatory requirements and guidelines for reporting post approval changes and updating global product registrations
Develop and evaluate global CMC regulatory strategies in collaboration with other regulatory, manufacturing, quality and project personnel to enable timely completion of submission milestones leading to health authority approval
Development of regulatory strategy and update strategy based upon global regulatory changes
Provide regulatory guidance to allow CMC teams to make informed decisions on global registrations and product lifecycle planning
Anticipate and resolve key technical or operational issues that could impact the function, CMC team and/or submission timing
Take on and independently manage challenging projects and identify creative and/or alternative solutions that support functional and partner organization requirements
Take a proactive leadership role in the critical review of molecule specific CMC development strategies and submission content for registration, post-approval changes, line extensions or renewals, and responses to questions
Make decisions on CMC regulatory strategies impacting product submissions across geographies and networks for alignment with CMC team members
Engage in site-specific regulatory activities to ensure maintaining registered commitments at the manufacturing site(s) for which they have responsibility for

Skills

CMC

Regulatory Affairs

Solid Oral Products

Post-Approval Changes

Global Regulatory Strategies

Manufacturing Processes

Lifecycle Management

ICH Guidelines

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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