Regulatory Affairs Senior Manager
4 weeks ago
The Senior Manager in Regulatory Affairs at Arcus Biosciences is responsible for developing and managing regulatory strategies to ensure compliance with U.S. FDA and global regulatory bodies.
This role will provide direct support for regulatory submissions in the US, APAC, and other regions, working closely with clinical development, non-clinical, manufacturing, technical operations, and external stakeholders to ensure regulatory success.
The Senior Manager will be responsible for study-level activities, including managing the preparation, review, and submission of all components of regulatory submissions, such as INDs and amendments, BLAs/NDAs and supplements, annual reports, safety reports, etc.
Key responsibilities include serving as regulatory lead for study-level management teams, critically reviewing complex technical documents, and providing updates to project/study teams and senior management on regulatory activities.
The ideal candidate will have a Bachelor's degree in science or health field, 5+ years' experience in pharmaceutical or biopharmaceutical industry, and 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 are required.
Experience with CTD/eCTD and life cycle management, excellent attention to detail and accuracy, and excellent verbal, written, negotiation, and interpersonal communication skills are also essential.
This role can be based at our Hayward or Brisbane, CA location, and the anticipated salary range for fully qualified candidates is $160,000 - $175,000 USD annually.
Arcus Biosciences offers a competitive market-based salary, stock programs, a performance-based bonus, and a comprehensive benefits package.
Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.
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