Global Regulatory Strategy Director — Hybrid + Equity

CSL; King of Prussia (PA); Hybrid; USD 242,000 - 270,000; Full time

Job summary

CSL is seeking a Director, Senior Global Regulatory Lead (Sr. GRL) to steer global regulatory strategies across the product lifecycle. You will interact with health authorities and lead cross-functional teams to align development decisions with business goals.

The role demands a track record of 10+ years in Regulatory Affairs within biotech/pharma, strong leadership, and deep knowledge of US/EU/Japan regulatory landscapes. Hybrid work model with onsite presence in multiple locations.

Qualifications

• Minimum of 10 years in biotech/pharma with at least 8 years in Regulatory Affairs.
• At least 5 years of experience leading teams (direct or matrix).
• Strong knowledge of US, EU, and/or Japan regulatory requirements.
• Experience working with major health authorities such as FDA or EMA.

Responsibilities

• Develop global regulatory strategies for assigned products across lifecycle.
• Serve as primary GRA representative on Product Strategy Teams and cross-functional groups.
• Lead health authority engagement including FDA and EMA.
• Oversee GRA strategy team, priorities, and cross-functional alignment.
• Provide regulatory guidance to senior leadership and teams.
• Lead strategic regulatory deliverables like Core Briefing Books, Orphan Designations, Pediatric Study Plans, and GR Strategy outlines.
• Drive regulatory intelligence, leveraging data, insights, and analytics to inform strategy.
• Promote global regulatory alignment with regional regulatory teams and CMC.
• Coach and develop Regional Regulatory Leads and foster talent growth.
• Demonstrate CSL leadership capabilities and drive accountability across teams.

Education

Bachelor’s degree in Pharmacy, Biology, Chemistry, Pharmacology, Clinical Medicine, or a related life science discipline

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

Job description

CSL is seeking a Director, Senior Global Regulatory Lead (Sr. GRL) to steer global regulatory strategies across the product lifecycle. You will interact with health authorities and lead cross-functional teams to align development decisions with business goals.

The role demands a track record of 10+ years in Regulatory Affairs within biotech/pharma, strong leadership, and deep knowledge of US/EU/Japan regulatory landscapes. Hybrid work model with onsite presence in multiple locations.