Regional Regulatory Lead (Hybrid, Equity)

BioSpace; Waltham (MA); Hybrid; USD 129,000 - 153,000; Full time

Job summary

CSL Behring is seeking a Regulatory Leader to shape regional and global regulatory strategies for assigned products, ensuring timely approvals and sound risk management. The role partners with GRL, GRAST, and regional teams to ensure a unified regulatory voice and effective document preparation.

Based in a hybrid setting (Waltham, MA or King of Prussia, PA) with 3 onsite days weekly, the candidate will navigate FDA/EMA requirements, support core submissions, and drive positive regulatory

Qualifications

• Bachelor’s degree in Pharmacy, Biology, Chemistry or related life science field; advanced degree preferred.
• Minimum 5+ years of regulatory/submission experience in biotech/pharma.
• At least 3+ years on developmental products.
• Experience with health authority interactions (FDA/EMA) is preferred.
• Ability to operate in a complex matrix with strategic thinking.

Responsibilities

• Own regional health authority relationships and help shape regulatory outcomes.
• Develop regional knowledge on requirements, filing pathways and processes.
• Support core document preparation and health authority engagements under GRL.
• Contribute to GRAST activities and ensure timely regulatory deliverables.
• Maintain regulatory systems (e.g., Veeva) and internal communications.

Skills

Regulatory experience

Global regulatory strategy

Risk assessment

Communication skills

Matrix environment

Education

Bachelor in life sciences

Advanced degree preferred

Job description

CSL Behring is seeking a Regulatory Leader to shape regional and global regulatory strategies for assigned products, ensuring timely approvals and sound risk management. The role partners with GRL, GRAST, and regional teams to ensure a unified regulatory voice and effective document preparation.

Based in a hybrid setting (Waltham, MA or King of Prussia, PA) with 3 onsite days weekly, the candidate will navigate FDA/EMA requirements, support core submissions, and drive positive regulatory