Sr Manager, Global Regulatory Affairs, WCH

Senior Manager supporting global regulatory strategy and execution for assigned programs at a biotechnology company. Role involves cross-functional collaboration on regulatory submissions across multiple regions, health authority interactions, and regulatory operations management.

Responsibilities

• Support regulatory strategy and execution with Global Regulatory Lead for assigned programs
• Lead or support review of regulatory submission packages including INDs, CTAs, NDAs/BLAs, and supplements
• Manage health authority query responses ensuring timely and accurate resolution
• Coordinate with Regulatory Operations and CROs on submission logistics and document delivery
• Maintain regulatory systems to track submission approvals and support US labeling implementation

Requirements

• Bachelor's degree with 5+ years regulatory affairs experience in pharmaceutical or biotech
• Strong knowledge of global regulatory requirements, guidelines, and policy interpretation
• Demonstrated ability managing IND, CTA, NDA/BLA submissions across multiple regions
• Strong project management, planning, and organizational skills
• Excellent oral and written communication for regulatory and cross-functional audiences
• Proficiency with regulatory systems such as Veeva Vault, Docubridge, and CTIS
• Proven ability to work independently in fast-paced, matrixed environment

Compensation: $140,000–$187,250 base