Regulatory Affairs Scientist / Specialist
What this job does:
Serves as the bridge between a company developing drugs, devices, or biological products and the government agencies (like the FDA) that approve them. Day-to-day, prepares detailed submission documents, interprets complex regulations, and develops strategies to get products approved efficiently. Coordinates closely with R&D, clinical, and manufacturing teams to ensure products meet all safety and legal standards before reaching patients.
This job is similar to these lab/research tasks:
Writing detailed scientific documents under deadline, critically evaluating and synthesizing complex scientific literature, communicating technical information to diverse audiences including committees and collaborators
Typical starting salary range
$90k to $155k
Salary estimate represented as 25th to 75th percentile. Gathered from recent job postings, Glassdoor.com, and Salary.com
Daily task breakdown
- Regulatory writing and submission preparation (30%)
- Reviewing and interpreting regulations, guidances, and scientific documents (25%)
- Cross-functional meetings and stakeholder communication (20%)
- Strategy development and regulatory planning (15%)
- Other: training, monitoring regulatory changes, agency correspondence (10%)
Skills you'll use in this job:
Scientific writing and regulatory document preparation; FDA/EMA/ICH regulatory knowledge; project management; cross-functional communication; attention to detail; analytical and critical thinking; knowledge of GxP (GLP/GCP/GMP); electronic submission systems (eCTD); risk assessment; negotiation and consensus-building
Talk about these PhD skills in your resume and interview:
Talk about your scientific writing skills - the core deliverable in regulatory affairs, directly analogous to grant writing and manuscript preparation. Highlight your ability to critically evaluate and synthesize complex scientific literature (clinical data, preclinical studies), your familiarity with experimental design and data interpretation, and your experience communicating technical information to diverse audiences including thesis committees and collaborators.
Alternative job titles to search:
Regulatory Affairs Associate; Senior Regulatory Affairs Specialist; Regulatory Scientist; Regulatory Strategy Specialist; Regulatory Submissions Specialist; CMC Regulatory Affairs Specialist; Global Regulatory Affairs Specialist; Regulatory Affairs Manager
*Note:
-Job titles are inconsistent between companies. Try various keywords.
-PhDs tend to undershoot seniority level. Target higher than you think.
