At a pharma, biotech, or medical-device company, you support regulatory submissions to FDA and international agencies — preparing submission components, managing document lifecycle, coordinating with cross-functional contributors, and ensuring submissions meet agency format and content standards.
A typical week often involves submission planning, document assembly, formatting and QC, and coordination with authors across functions — building submission timelines, assembling components from clinical, CMC, and regulatory teams, performing format and content QC, working with publishing teams on final assembly. You're often the operational engine behind a submission that may run thousands of pages. Submissions delivered on time and at agency-acceptable quality are the operating measures.
The harder part is often the integration work across functions — each contributor authors in their own style, and the associate weaves their outputs into a coherent whole. Variance across employers is wide: at large pharma the role runs in deep regulatory operations groups with publishing software; at smaller biotech or device companies it tilts more generalist.
Folks who fit this role are organized, detail-oriented, and patient with multi-author document assembly. RAC credentials and submission-software training anchor advancement. The trade-off is the deadline-driven intensity as submission dates approach and the long hours that filing weeks often involve.
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Roles like this one sit within a broader occupational category. The numbers below reflect that full landscape — helpful for context, but your specific experience will depend on level, specialty, and where you work.
Roles with similar work and overlapping career paths
View all Business Operations roles →At a pharma, biotech, or medical-device company, you support regulatory submissions to FDA and international agencies — preparing submission components, managing document lifecycle, coordinating with cross-functional contributors, and ensuring submissions meet agency format and content standards.
Median pay for a Regulatory Submissions Associate is about $78K nationally, with the field ranging roughly from $46K to $130K depending on experience, employer, and metro (BLS).
Core skills for this role include Writing, Active Listening, Speaking, Judgment and Decision Making, and Critical Thinking.
Most people in this role hold a bachelor's degree.
Employment in this field is projected to grow about 3% through 2034, with roughly 397,770 people working in it today (BLS).
Closely related roles include Regulatory Director, Regulatory Affairs Executive, and Compliance Operations Manager.
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