The Manager in Regulatory Affairs is responsible for developing and managing regulatory strategies to remain compliant with U.S. FDA and global regulatory bodies. This position will provide direct support for regulatory submissions in the US, APAC, and other regions. The position will work closely with clinical development, nonclinical, manufacturing, and external stakeholders (consultants, CROs) to ensure regulatory success.
Responsibilities
- Manage the preparation, review, and submission of all components of regulatory submissions including INDs and amendments, 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 on the regulatory activities.
- Responsible for preparing and coordinating company responses to queries from health authorities.
- Responsible for planning and executing regulatory submissions requiring cross-functional collaboration and alignment.
- Implement new and ongoing regulatory activities to support company goals.
- Responsible for timely compilation of all necessary documents to support regulatory submissions.
- Ensure cross-functional alignment on regulatory strategies.
Qualifications
- Bachelor’s degree in science or health field required; advance degree is a plus
- 3+ years experience in regulatory affairs, clinical drug development, manufacturing, or clinical related function in the pharmaceutical or biopharmaceutical industry
- 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 (preferred) or can be remote based. The anticipated salary range for fully qualified candidates applying for this position is $148,000 - $160,000 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.
EOE
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 identity, 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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