Director, Regulatory Affairs
Functional leader
Career Explorer · Quality, Regulatory & Product Safety · Regulatory Affairs Management
Standard where organizational scale supports the level
What the role involves
- Autonomy
- Department / major product or regional function
- Scope
- Department / major product or regional function
- Time horizon
- 1-2 years
- Expertise and judgement
- Sets functional strategy, operating model and investment priorities
- Expected impact
- Department/business outcomes
Expected skills (24)
Grouped as human, professional and technical. Target proficiency uses the P1–P5 scale, and each row says what that level means for that particular skill.
Human (11)
| Skill | Importance | Target | What that level looks like |
|---|---|---|---|
| Coaching Collaboration & Leadership | Core | P4 | Sets standards, integrates the skill across teams and resolves novel or high-impact problems. |
| Decision making Thinking & Judgment | Core | P4 | Sets standards, integrates the skill across teams and resolves novel or high-impact problems. |
| Delegation Collaboration & Leadership | Core | P4 | Sets standards, integrates the skill across teams and resolves novel or high-impact problems. |
| Executive communication Communication & Influence | Core | P4 | Sets standards, integrates the skill across teams and resolves novel or high-impact problems. |
| Feedback delivery Collaboration & Leadership | Core | P4 | Sets standards, integrates the skill across teams and resolves novel or high-impact problems. |
| Risk judgment Thinking & Judgment | Core | P4 | Sets standards, integrates the skill across teams and resolves novel or high-impact problems. |
| Stakeholder management Communication & Influence | Core | P4 | Sets standards, integrates the skill across teams and resolves novel or high-impact problems. |
| Strategic thinking Thinking & Judgment | Core | P4 | Sets standards, integrates the skill across teams and resolves novel or high-impact problems. |
| Talent development Collaboration & Leadership | Core | P4 | Sets standards, integrates the skill across teams and resolves novel or high-impact problems. |
| Conflict resolution Communication & Influence | Supporting | P4 | Sets standards, integrates the skill across teams and resolves novel or high-impact problems. |
| Inclusive leadership Collaboration & Leadership | Supporting | P4 | Sets standards, integrates the skill across teams and resolves novel or high-impact problems. |
Professional (11)
| Skill | Importance | Target | What that level looks like |
|---|---|---|---|
| Business acumen Business & Strategy | Core | P4 | Sets standards, integrates the skill across teams and resolves novel or high-impact problems. |
| Financial acumen Business & Strategy | Core | P4 | Sets standards, integrates the skill across teams and resolves novel or high-impact problems. |
| Performance management Business & Strategy | Core | P4 | Sets standards, integrates the skill across teams and resolves novel or high-impact problems. |
| Corrective and Preventive Action (CAPA) Quality & Regulatory | Supporting | P4 | Sets cross-team standards and governance for Corrective and Preventive Action (CAPA), integrating risk, metrics and stakeholder needs. |
| Good Manufacturing Practices (GMP) Quality & Regulatory | Supporting | P4 | Sets cross-team standards and governance for Good Manufacturing Practices (GMP), integrating risk, metrics and stakeholder needs. |
| ISO 13485 Quality & Regulatory | Supporting | P4 | Sets cross-team standards and governance for ISO 13485, integrating risk, metrics and stakeholder needs. |
| Process validation Quality & Regulatory | Supporting | P4 | Sets cross-team standards and governance for Process validation, integrating risk, metrics and stakeholder needs. |
| Quality Management Systems (QMS) Quality & Regulatory | Supporting | P4 | Sets cross-team standards and governance for Quality Management Systems (QMS), integrating risk, metrics and stakeholder needs. |
| Quality documentation Quality & Regulatory | Supporting | P4 | Sets cross-team standards and governance for Quality documentation, integrating risk, metrics and stakeholder needs. |
| Quality risk management Quality & Regulatory | Supporting | P4 | Sets cross-team standards and governance for Quality risk management, integrating risk, metrics and stakeholder needs. |
| Resource management Program, Risk & Sustainability | Supporting | P4 | Sets standards, integrates the skill across teams and resolves novel or high-impact problems. |
Technical (2)
| Skill | Importance | Target | What that level looks like |
|---|---|---|---|
| Root cause analysis Quality Engineering & Statistics | Supporting | P4 | Designs standards/approaches for Root cause analysis, leads cross-team implementation and mentors practitioners. |
| Statistical Process Control (SPC) Quality Engineering & Statistics | Supporting | P4 | Designs standards/approaches for Statistical Process Control (SPC), leads cross-team implementation and mentors practitioners. |
Career ladder
Reached from
Next steps
- Senior Director, Regulatory AffairsM4Management promotion
Move from department leadership to large multi-portfolio leadership; integrate functions, influence enterprise decisions and strengthen the leadership pipeline.
What changes to advance
Move from department leadership to large multi-portfolio leadership; integrate functions, influence enterprise decisions and strengthen the leadership pipeline.
Source: PROCOMER FTZ benchmark; SFIA; PMI · MF371-M3