The Principal Consultant, Regulatory Affairs CMC will primarily be responsible for the daily management of regulatory requirements for one or more clients, designing and implementing submission strategy, and developing and maintaining relationships with key client staff and regulatory authorities
Job Summary
The Principal Consultant, Regulatory Affairs CMC will primarily be responsible for the daily management of regulatory requirements for one or more clients, designing and implementing submission strategy, and developing and maintaining relationships with key client staff and regulatory authorities.
Provide high-level strategy input on critical regulatory filing documents to facilitate and expedite the development, licensure, and marketing of drugs and/or biologics.
Opus is committed to providing benefit-eligible employees with a comprehensive benefits package designed to support your health, financial well-being, and work-life balance.
Matching Summary
The Principal Consultant, Regulatory Affairs CMC will primarily be responsible for the daily management of regulatory requirements for one or more clients, designing and implementing submission strategy, and developing and maintaining relationships with key client staff and regulatory authorities.
Skills & Requirements
Must-have
CMC regulatory guidance and strategy
regulatory filing documents
interactions with global regulatory authorities
authoring complex technical documents
RA-CMC compliance activities
monitoring emerging legislation and guidance
Nice-to-have
strategic guidance to industry partners
customized solutions to meet challenges
work in a dynamic pharmaceutical environment
Key Requirements
7 years pharmaceutical/biotech industry experience
5 years relevant regulatory affairs CMC experience