Senior Director Global Regulatory Affairs

Blackfield Associates are exclusively partnered with a pharma client search for a Senior Director, Global Regulatory Lead, to from their Paediatric development team.

This is a highly strategic leadership role partnering across discovery, development, and commercial teams to define and execute global paediatric regulatory strategies across multiple therapeutic areas, including rare disease and oncology. The successful candidate will be a hands on regulatory voice and a people leader within the organisation.

Key Responsibilities:

• Lead the development and execution of global paediatric regulatory strategies, including pediatric plans, submissions, and lifecycle commitments
• Provide strategic regulatory leadership across early through late stage development
• Represent the company as a 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

Required Skills and Experience:

• Extensive experience in Global Regulatory Affairs, gained in pharma and developing global paediatric regulatory strategies. Minimum 12 years.
• Educated to advanced degree level in relevant scientific disciplines
• Extensive leadership experience and proven effectiveness through direct people leadership or matrix leadership- Minimum 4 previous direct reports
• Extensive experience and significant successes setting and directing the regulatory or related strategy to successful conclusion for multiple products.
• Experience across multiple development therapeutic areas (Virology, Oncology, Inflammation preferred)
• Track record of effective health authority engagement and negotiation
• Ability to influence at executive level and drive alignment across global teams
• Must have significant Paediatric experience throughout your regulatory career

This is a rare opportunity to shape paediatric regulatory strategy at a global level, influence pipeline development across multiple therapeutic areas, and play a central role in advancing treatments for children with serious diseases.

Applicants from Pharma /Biopharma only. Due to the nature of this role, we are not considering CRO or consultancy candidates.

Hybrid working, candidate must be able to attend the Dublin office on a weekly basis.