M2M2 — Manager II

Experienced Manager

Regulatory Affairs Manager II / Senior Manager

What this level means

Manages an established team or sub-function; owns planning and performance for the group.

Scope
An established team or sub-function
Autonomy
Owns planning for the group
Complexity
Cross-project coordination and priorities
Impact
Group delivery and development
Decision rights
Owns staffing, priorities, performance for the group
Leadership
Manages a team; sometimes manages leads
Typical experience
5–8 yrs

What you'd do

  • Manages multiple projects or a larger program within the RA portfolio.
  • Develops regulatory plans for projects.
  • Serves as an RA point of contact for clients on assigned projects.
  • Ensures that regulatory documentation systems are maintained for their projects.
  • Supervises M1-level RA staff or specialists.
  • Manage RA projects
  • Develop regulatory plans
  • Supervise RA staff

Skills, knowledge & tools

  • Project management
  • Regulatory planning
  • Client communication
  • Documentation management
  • Leadership
  • Regulatory project management
  • Client relationship management
  • Documentation systems
  • Regulatory strategies
  • Team supervision
  • Leadership & People Management
  • Project management
  • Regulatory Judgement
  • Negotiation & Influence
  • Adaptability

What good looks like

  • Bachelor’s degree in a relevant field
  • 7–10 years of regulatory affairs experience
  • Master’s degree or RAC certification preferred

Common titles

Manager, Regulatory Affairs (CDMO)Regulatory Affairs (CDMO) ManagerExperienced Manager

Where it sits & what it pays

O*NET / SOC: 11-9199.01Regulatory Affairs Managers

Market-pay benchmarks for this family × level are coming — JobFrame anchors pay to the family/level structure rather than the raw title.