Regulatory affairs positions in Biotech

The Regulatory Affairs Director plans and directs the group's activities. This involves interpreting policy, formulating strategies on how to best complete a submission and advising project teams. The Director also interfaces with external parties in regulatory agencies to resolve issues and successfully shepherd a drug through the regulatory process. Typical salaries range from $90K to $160K. In larger departments, the Director is assisted by a Regulatory Affairs Manager, who supervises these activities as well as stay abreast of domestic and foreign registration requirements, prepare supplements and amendments to reports and monitor program costs. Typical salaries range from $65K to $110K.

Regulatory Affairs Associates do most the hands-on work of the group. They ensure that all regulatory requirements are met, prepare document packages, maintain files and archives and provide reports and other documentation to other departments (e.g., manufacturing, QA/QC, medical affairs, and clinical research). College graduates can get into this position at the entry level and attain significant responsibility after several years on the job. Typical salaries range from $40K to $95K.

Documentation Associates/Assistants coordinate the actual production of regulatory reports and maintain electronic files of drafts, reference collections and archives. They also interface with project teams (i.e., writers, editors, etc.) to ensure timeliness of submissions and often maintain the software and hardware infrastructure. Typical salaries range from $35K to $85K.