M1M1 — Manager (Team Lead)
Entry Support
Regulatory Affairs Manager I (First-Line Manager)
What this level means
Front-line people manager of a single team; owns delivery, coaching, and execution.
- Scope
- A single team
- Autonomy
- Manages within established goals
- Complexity
- Day-to-day delivery and people issues
- Impact
- Team output and health
- Decision rights
- Owns team execution, hiring input, performance
- Leadership
- Direct people management of one team
- Typical experience
- 3–6 yrs
What you'd do
- Coordinates the preparation and submission of regulatory filings for client projects.
- Ensures day-to-day development and manufacturing activities adhere to regulations.
- Works closely with technical teams to gather necessary data and documentation for submissions.
- Monitors FDA guidances and industry alerts relevant to the projects.
- Assists in preparing for regulatory inspections or client audits.
- Prepare regulatory filings
- Gather data for submissions
- Monitor regulatory changes
Skills, knowledge & tools
- Regulatory filing preparation
- Data documentation
- Regulatory compliance
- Team collaboration
- Time management
- FDA regulations
- Regulatory submission processes
- Documentation standards
- Industry alerts
- Compliance requirements
- Attention to detail
- Communication Skills
- Time management
- Collaboration
- Problem-solving
What good looks like
- Bachelor’s degree in life sciences, pharmacy, engineering or related field
- 5–7 years of total industry experience in regulatory affairs
- Regulatory Affairs Certification (RAC) or similar credential preferred
Common titles
Manager, Regulatory Affairs (CDMO)Regulatory Affairs (CDMO) ManagerEntry Support
Where it sits & what it pays
O*NET / SOC: 11-9199.01 — Regulatory Affairs Managers
Market-pay benchmarks for this family × level are coming — JobFrame anchors pay to the family/level structure rather than the raw title.