Regulatory Affairs Manager - Meet : Job Details

Description

The Senior 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 providing direct support for regulatory submissions in the U.S., APAC, and other regions. The Senior Manager will collaborate closely with clinical development, non-clinical, manufacturing, technical operations, and external stakeholders (consultants, CROs) to ensure regulatory success, focusing on study-level activities.

Note: This is an office-based role with a hybrid requirement of 3 days onsite in 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 the 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 regulatory activities.
• Prepare and coordinate company responses to queries from health authorities.
• Plan and execute regulatory submissions requiring cross-functional collaboration and alignment.
• Offer guidance for the rollout and implementation of new and ongoing regulatory activities to support company goals.
• Ensure timely compilation of all necessary documents to support regulatory submissions.
• Maintain cross-functional alignment on regulatory strategies.

Qualifications

• Bachelor's degree in a science or health-related field required; advanced degree is a plus.
• 5+ years of experience in the pharmaceutical or biopharmaceutical industry.
• 3+ years of experience in regulatory strategy or relevant experience.
• Extensive knowledge of regulatory requirements, including ICH and regional guidelines, 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.
• Strong verbal, written, negotiation, and interpersonal communication skills are required.