Arcus Biosciences Inc.
Senior Manager, Regulatory Affairs, Bay Area, Office-based, Hybrid
Arcus Biosciences Inc., California, Missouri, United States, 65018
The Sr. 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, non-clinical, manufacturing, technical operations, and external stakeholders (consultants, CROs) to ensure regulatory success. The responsibilities of the Senior Manager are study level activities.Note:
This an office-based role with a hybrid requirement of 3 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.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.Provide guidance for roll-out and implementation of 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.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.
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This an office-based role with a hybrid requirement of 3 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.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.Provide guidance for roll-out and implementation of 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.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.
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