Thermo Fisher Scientific is seeking a Sr. Manager of Regulatory Affairs for their St. Louis facility, where the candidate will ensure regulatory excellence in a cGMP environment. The role emphasizes leadership, collaboration, and experience in navigating complex regulatory landscapes, particularly for biologics
Job Summary
This position will play a critical role in ensuring our St. Louis Biologics site remains a trusted CDMO partner by delivering regulatory excellence, proactive risk management, and seamless support for sponsor interactions with FDA and international regulatory agencies.
We are seeking a strong regulatory leader with demonstrated experience supporting biologic programs, bringing deep expertise in navigating complex global regulatory requirements within a cGMP manufacturing environment.
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits.
Matching Summary
Match Score: 85
Thermo Fisher Scientific is seeking a Sr. Manager of Regulatory Affairs for their St. Louis facility, where the candidate will ensure regulatory excellence in a cGMP environment. The role emphasizes leadership, collaboration, and experience in navigating complex regulatory landscapes, particularly for biologics.
Skills & Requirements
Must-have
regulatory excellence
proactive risk management
sponsor interactions with regulatory agencies
cGMP manufacturing environment
global regulatory requirements for biologic products
Nice-to-have
dynamic CDMO environment
complex global initiatives
high-visibility, cross-functional impact
integrity, intensity, involvement, and innovation
Key Requirements
8+ years in a Quality role in a cGMP environment
5+ years managing people
5+ years regulatory experience in the biopharmaceutical or CDMO related industry
Bachelor’s degree or equivalent in a scientific or related field
Experience authoring, reviewing, or supporting CMC sections for IND/BLA, and/or MAA submissions
Work Rights
Must be legally authorized to work in the United States