Regulatory Affairs Senior Manager
1 week ago
The Senior Manager in Regulatory Affairs plays a critical role in developing and managing regulatory strategies to ensure compliance with U.S. FDA and global regulatory bodies. This position provides 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.
Key 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 reviewing complex technical documents and influencing colleagues across functions.
- Provide updates to project/study teams and senior management on regulatory activities, responsible for preparing and coordinating company responses to queries from health authorities.
- Plan and execute regulatory submissions requiring cross-functional collaboration and alignment, providing 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, cross-functional alignment on regulatory strategies.
- Bachelor's degree in science or health field required; advance 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 are required.
This role can be based at our Hayward or Brisbane, CA location. The anticipated salary range for fully qualified candidates applying for this position is $160,000 - $175,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position. The actual salary may vary based on various factors including, without limitation, individual education, experience, tenure, skills and abilities, internal equity and alignment with market data. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be found here: https://www.arcusbio.com/careers/total-rewards
Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets
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