Senior Manager, Regulatory Affairs, Bay Area, Office-based, Hybrid

$160,000 - $175,000/Yr

Arcus Biosciences - Hayward, CA

Full-time - Mid Level

Remote - Hayward, CA

Professional, Scientific, and Technical Services

About the position

The Sr. Manager in Regulatory Affairs is responsible for developing and managing regulatory strategies to ensure compliance with U.S. FDA and global regulatory bodies. This role involves direct support for regulatory submissions across various regions, including the US and APAC, and requires collaboration with multiple internal and external stakeholders to achieve regulatory success. The position is office-based with a hybrid requirement of three days onsite in Brisbane or Hayward, CA.

Responsibilities

• Manage the preparation, review, and submission of all components of regulatory submissions including INDs and amendments, BLAs/NDAs and supplements, annual reports, safety reports, etc.
• Serve as regulatory lead for study-level management teams.
• Critically review complex technical documents and influence colleagues across functions.
• Provide updates to project/study teams and senior management on the regulatory activities.
• Prepare and coordinate company responses to queries from health authorities.
• Plan and execute regulatory submissions requiring cross-functional collaboration and alignment.
• Provide guidance for roll-out and implementation of new and ongoing regulatory activities to support company goals.
• Ensure timely compilation of all necessary documents to support regulatory submissions.
• Ensure cross-functional alignment on regulatory strategies.

Requirements

• Bachelor's degree in science or health field required; advanced degree is a plus.
• 5+ years' experience in pharmaceutical or biopharmaceutical industry.
• 3+ years' experience in regulatory strategy or relevant experience.
• Extensive knowledge of regulatory requirements, including ICH and regional requirements and an understanding of current global and regional trends in regulatory affairs.
• Experience with CTD/eCTD and life cycle management.
• Excellent attention to detail and accuracy.
• Excellent verbal, written, negotiation, and interpersonal communication skills.

Benefits

• Competitive market-based salary
• Participation in stock programs
• Performance-based bonus
• Comprehensive benefits package