Regulatory Strategy Lead – FDA Submissions & Lifecycle
ritedoseColumbia (SC)
Regulatory Strategy Lead – FDA Submissions & Lifecycle
Posted today
ritedoseColumbia (SC)
SENIORITY
Manager
About the role
The Ritedose Corporation in Columbia, SC is seeking a Regulatory Affairs Manager to lead regulatory strategies for ANDA submissions and provide CDMO support for customer-led submissions (FDA and global). This role ensures compliance and lifecycle management in line with the Director of Regulatory Affairs.
Responsibilities include authoring and editing technical documents, serving as RA lead on teams, and publishing to FDA for lifecycle submissions while guiding junior staff and monitoring
Before you apply
Applying takes about a minute. These four things decide how fast it moves after that.
Your profile is current
It's what we read first. Occupations, seniority and locations matter more than a long history.
Two examples you can talk through
Not a portfolio — just two pieces of work where you can explain the decisions and what you'd change.
A number in mind
What you're on now and what would make you move. We negotiate better when we know both.
Your notice period
Employers plan around it, and it's the question that stalls offers most often.
Once you apply, someone reads it and calls you before anything reaches the employer — usually within two working days.
More like this