Global Regulatory Strategy Director (Hybrid)

Regulatory Jobs; King of Prussia (PA); Híbrido; USD 242.000 - 270.000; Jornada completa

Descripción de la vacante

CSL Behring seeks a Director, Senior Global Regulatory Lead to drive science-based regulatory strategies across product lifecycles. You will serve as the primary GRA representative on product strategy teams and lead regulatory activities in collaboration with Clinical Development, Safety, and Commercial teams.

In this highly visible role, build relationships with FDA/EMA, guide regulatory pathways, and mentor regional leads where applicable.

Formación

• Bachelor's degree in Pharmacy, Biology, Chemistry, Pharmacology, Clinical Medicine, or related life science discipline required.
• Advanced degree (MS, PhD, MD, DVM) or MBA preferred.
• Minimum 10 years in biotech/pharma with at least 8 years in Regulatory Affairs.

Responsabilidades

• Develop Global Regulatory Strategy for assigned products across lifecycle.
• Lead Cross-Functional Regulatory Partnership with PSTs, Clinical Development, Safety, Commercial, and other stakeholders.
• Drive Health Authority engagement with FDA/EMA and regional partners.
• Provide Regulatory Leadership and Oversight for the GRA Strategy Team (GRAST).
• Influence product development decisions and approve strategic regulatory documents as appropriate.
• Lead strategic regulatory deliverables including Core Briefing Books, Orphan Drug Designations, Pediatric Study Plans, and GRSO.

Conocimientos

Regulatory strategy

Leadership

Cross-functional collaboration

Regulatory affairs leadership

US/EU/Japan regulatory knowledge

Educación

Bachelor's degree in life sciences

Advanced degree preferred (MS/PhD/MD/DVM or MBA)

Descripción del empleo

CSL Behring seeks a Director, Senior Global Regulatory Lead to drive science-based regulatory strategies across product lifecycles. You will serve as the primary GRA representative on product strategy teams and lead regulatory activities in collaboration with Clinical Development, Safety, and Commercial teams.

In this highly visible role, build relationships with FDA/EMA, guide regulatory pathways, and mentor regional leads where applicable.