Senior Director, Global Pediatric Regulatory Strategy

Blackfield Associates; Dublin; Hybrid; EUR 180,000 - 240,000; Full time

Benefits offered by this job

Hybrid working in Dublin

Job summary

Blackfield Associates is working with a pharma client to recruit a Senior Director, Global Regulatory Lead for paediatric development across discovery, development and early commercial teams. This is a highly strategic leadership role requiring deep global regulatory expertise and a hands-on, people-centric approach.

The successful candidate will shape pediatric regulatory strategy across multiple therapeutic areas, lead a matrix regulatory team, engage health authorities, and partner with

Qualifications

• Extensive experience in Global Regulatory Affairs and pediatric strategy.
• Proven leadership with direct or matrix reporting structures.
• Track record of successful global regulatory strategies across multiple products.
• Experience across Virology, Oncology, Inflammation.
• Strong health authority engagement and executive influence.

Responsibilities

• Lead global paediatric regulatory strategies, plans, submissions, and lifecycle commitments.
• Provide strategic regulatory leadership across early through late-stage development.
• Represent the company as primary contact for regulatory authorities’ negotiation and representations.
• Identify regulatory and paediatrics specific risks and develop mitigation strategies.
• Leading a matrix team - Lead, mentor, and develop regulatory team members directly.
• Part of the country’s Senior leadership team and support the wider group with oversight and achieving development/ commercial goals.

Skills

Global Regulatory Affairs

Paediatric Regulatory Strategy

Leadership & People Management

Regulatory Negotiations

Cross-functional collaboration

Education

Advanced degree in life sciences

Job description

Blackfield Associates is working with a pharma client to recruit a Senior Director, Global Regulatory Lead for paediatric development across discovery, development and early commercial teams. This is a highly strategic leadership role requiring deep global regulatory expertise and a hands-on, people-centric approach.

The successful candidate will shape pediatric regulatory strategy across multiple therapeutic areas, lead a matrix regulatory team, engage health authorities, and partner with