M3M3 — Senior Manager
Mid-level Leader
Regulatory Affairs Manager III / Associate Director
What this level means
Leads multiple teams or a sub-function; sets goals and owns cross-team execution.
- Scope
- Multiple teams or a sub-function
- Autonomy
- Sets goals within functional strategy
- Complexity
- Multi-team execution and resourcing trade-offs
- Impact
- Sub-function outcomes
- Decision rights
- Owns goals, budget input, and people decisions across teams
- Leadership
- Manages managers and/or several teams
- Typical experience
- 8–12 yrs
What you'd do
- Leads the RA function for a significant segment of the business.
- Formulates comprehensive regulatory strategies for programs.
- Serves as the lead liaison to FDA for projects in their portfolio.
- Implements improvements in RA processes and tools.
- Collaborates with senior leaders to align operational decisions with regulatory requirements.
- Lead RA functions
- Develop regulatory strategies
- Implement process improvements
Skills, knowledge & tools
- Strategic planning
- Cross-functional leadership
- Decision-making
- Communication
- Mentorship
- Regulatory strategy development
- FDA liaison processes
- Process improvement
- Leadership collaboration
- Regulatory alignment
- Strategic Thinking
- Cross-functional leadership
- Decision-making
- Advanced communication
- Mentorship
What good looks like
- Advanced degree (MS/PhD in scientific discipline or PharmD or JD) or MBA
- 10+ years in regulatory affairs
Common titles
Senior Manager, Regulatory Affairs (CDMO)Regulatory Affairs (CDMO) Senior ManagerMid-level Leader
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.