Senior Manager, Regulatory Affairs

Manager of a large team or managers

Explorador de carreras · Quality, Regulatory & Product Safety · Regulatory Affairs Management

M2 · Senior ManagerContribución individualSenior Manager

Standard where organizational scale supports the level

Qué implica el puesto

Autonomía: Multiple teams / one capability
Alcance: Multiple teams / one capability
Horizonte de tiempo: Quarterly-annual
Experticia y criterio: Balances portfolios, develops managers, allocates resources
Impacto esperado: Multi-team outcomes and bench strength

Habilidades esperadas (24)

Agrupadas en humanas, profesionales y técnicas. La proficiencia meta usa la escala P1–P5, y cada fila describe qué significa ese nivel para esa habilidad en particular.

Humanas (11)

Habilidad	Importancia	Meta	Qué se espera en ese nivel
Coaching Collaboration & Leadership	Core	P3	Handles complex situations, adapts methods and coaches less-experienced colleagues.
Decision making Thinking & Judgment	Core	P3	Handles complex situations, adapts methods and coaches less-experienced colleagues.
Delegation Collaboration & Leadership	Core	P3	Handles complex situations, adapts methods and coaches less-experienced colleagues.
Executive communication Communication & Influence	Core	P3	Handles complex situations, adapts methods and coaches less-experienced colleagues.
Feedback delivery Collaboration & Leadership	Core	P3	Handles complex situations, adapts methods and coaches less-experienced colleagues.
Risk judgment Thinking & Judgment	Core	P3	Handles complex situations, adapts methods and coaches less-experienced colleagues.
Stakeholder management Communication & Influence	Core	P3	Handles complex situations, adapts methods and coaches less-experienced colleagues.
Strategic thinking Thinking & Judgment	Core	P3	Handles complex situations, adapts methods and coaches less-experienced colleagues.
Talent development Collaboration & Leadership	Core	P3	Handles complex situations, adapts methods and coaches less-experienced colleagues.
Conflict resolution Communication & Influence	Supporting	P3	Handles complex situations, adapts methods and coaches less-experienced colleagues.
Inclusive leadership Collaboration & Leadership	Supporting	P3	Handles complex situations, adapts methods and coaches less-experienced colleagues.

Profesionales (11)

Habilidad	Importancia	Meta	Qué se espera en ese nivel
Business acumen Business & Strategy	Core	P3	Handles complex situations, adapts methods and coaches less-experienced colleagues.
Financial acumen Business & Strategy	Core	P3	Handles complex situations, adapts methods and coaches less-experienced colleagues.
Performance management Business & Strategy	Core	P3	Handles complex situations, adapts methods and coaches less-experienced colleagues.
Corrective and Preventive Action (CAPA) Quality & Regulatory	Supporting	P3	Owns complex Corrective and Preventive Action (CAPA) cases/processes, improves controls and coaches colleagues.
Good Manufacturing Practices (GMP) Quality & Regulatory	Supporting	P3	Owns complex Good Manufacturing Practices (GMP) cases/processes, improves controls and coaches colleagues.
ISO 13485 Quality & Regulatory	Supporting	P3	Owns complex ISO 13485 cases/processes, improves controls and coaches colleagues.
Process validation Quality & Regulatory	Supporting	P3	Owns complex Process validation cases/processes, improves controls and coaches colleagues.
Quality Management Systems (QMS) Quality & Regulatory	Supporting	P3	Owns complex Quality Management Systems (QMS) cases/processes, improves controls and coaches colleagues.
Quality documentation Quality & Regulatory	Supporting	P3	Owns complex Quality documentation cases/processes, improves controls and coaches colleagues.
Quality risk management Quality & Regulatory	Supporting	P3	Owns complex Quality risk management cases/processes, improves controls and coaches colleagues.
Resource management Program, Risk & Sustainability	Supporting	P3	Handles complex situations, adapts methods and coaches less-experienced colleagues.

Técnicas (2)

Habilidad	Importancia	Meta	Qué se espera en ese nivel
Root cause analysis Quality Engineering & Statistics	Supporting	P3	Independently applies Root cause analysis to complex work, troubleshoots issues and improves local practice.
Statistical Process Control (SPC) Quality Engineering & Statistics	Supporting	P3	Independently applies Statistical Process Control (SPC) to complex work, troubleshoots issues and improves local practice.

Escalera de carrera

Se llega desde

Manager, Regulatory AffairsM1

Siguientes pasos

Director, Regulatory AffairsM3Ascenso en gestión
Move from multi-team management to department leadership; set functional strategy, operating model, workforce plan and investment priorities.

People management requires sustained evidence of coaching, performance management, staffing judgment and organizational leadership - not simply greater individual expertise.

Qué cambia para avanzar

Move from multi-team management to department leadership; set functional strategy, operating model, workforce plan and investment priorities.

Fuente: PROCOMER FTZ benchmark; SFIA; PMI · MF371-M2