Sr. Manager of Regulatory Affairs, Biologicals and Chemicals
Thermo Fisher ScientificSalary not specified
Full Time
Expert & Leadership (9+ years)
Advisor - Global Regulatory Affairs CMC at Eli Lilly and Company
Indianapolis, Indiana, United States
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
PharmaceuticalsIndustries
Requirements
- B.S. degree in a science, engineering, or a related field
- Chemistry (preferred)
Responsibilities
- Develop and evaluate global CMC regulatory strategies in collaboration with other regulatory, Manufacturing, Quality, and project personnel
- Drive regulatory CMC strategies and develop post-approval and lifecycle regulatory strategies and submissions for Lilly’s commercial products
- Leverage innovative regulatory strategies to support the lifecycle of assigned products
- Provide regulatory guidance to CMC teams, enabling informed decisions on global registrations and product lifecycle planning
- Anticipate and resolve key technical or operational issues impacting the function, CMC team, and submission timing
- Independently manage challenging projects and identify creative solutions to meet functional and organizational requirements
- Take a proactive leadership role in reviewing CMC development strategies and submission content for registration, post-approval changes, line extensions, or renewals
- Make decisions on CMC regulatory strategies impacting product submissions across geographies and networks
Skills
CMC
Regulatory Affairs
Chemistry
Global Regulatory Strategy
Post-Approval Submissions
Lifecycle Management
Manufacturing
Quality Assurance
Regulatory Science
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