Regulatory Career Path
Role Summaries
Regulatory Submission Specialist
Pay Scale: 55k - 90k
Before a trial can be implemented, they coordinate the compilation of documents needed to support clinical trial applications for Health Authorities i.e., INDs, IDEs, CTIS submissions.
Regulatory Affairs Associate/ Specialist
Pay Scale: 65k - 120k
Compile, review, and submit pre-approval and post-approval regulatory documentation including clinical trial applications, annual reports, initial marketing applications and amendments such as INDs, IDEs, NDAs, BLAs, PMAs, 510ks, Denovo, etc.
Regulatory Affairs Manager
Pay Scale: 100k - 200k
Develop and execute regulatory strategies for assigned medical products and facilitate interactions with health authorities.
Director, Regulatory Affairs
Pay Scale: 130k - 310k
Defines regulatory strategies for medical products within business unit and typically serves as the Health Authority primary point of contact for product registration activities. If role includes people management, will also hire, mentor, and manage regulatory affairs personnel to implement regulatory strategies for business unit.