Senior Regulatory Affairs Specialist

Kelly® Science & Clinical is seeking a Senior Regulatory Affairs Specialist for a direct hire opportunity with one of our clients, a leading small molecule CDMO at their Irvine, CA facility. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Position Title: Senior Regulatory Affairs Specialist

Position Type: Direct hire

Workplace: Onsite in Irvine, CA

Salary Range: $85,000–$110,000 per year

Are you a seasoned regulatory affairs professional ready to make a significant impact in the pharmaceutical industry? We are seeking a dedicated Senior Regulatory Affairs Specialist to support our regulatory initiatives and drive successful outcomes throughout the product lifecycle—from development to commercialization and post-market compliance.

Key Responsibilities

Strategic Planning and Regulatory Support

• Lead the submission, approval, and lifecycle management for both ANDA and NDA filings.
• Contribute to the development, maintenance, and review of Standard Operating Procedures (SOPs) to ensure regulatory alignment and best practices.
• Develop robust regulatory strategies for product approvals, offering critical input from early product development through to commercialization.

Pre-Market Compliance

• Conduct comprehensive reviews of documentation for regulatory and quality compliance to ensure acceptance for submission.
• Oversee pre-approval compliance activities and submission batch manufacturing processes.
• Drive compliant label development and review, keeping abreast of evolving regulations and their impact on submissions.
• Ensure timely and accurate reporting to regulatory bodies, proactively monitoring regulatory changes and implementing recommendations.

Post-Market Excellence

• Manage and maintain annual licenses, registrations, drug listings, and patent information.
• Prepare and coordinate annual reports for NDA/ANDA products, ensuring thorough documentation and tracking of regulatory changes.
• Collaborate with cross-functional teams (QA, Manufacturing, Project Management, Engineering, Product Development, etc.) to facilitate accurate and timely FDA reporting.
• Conduct meticulous reviews of technical materials—including labeling, analytical procedures, specifications, batch records, and distribution reports—prior to submission.
• Serve as a primary liaison with the FDA and other regulatory agencies, resolving queries and issues efficiently.
• Prepare and oversee label revisions and approvals; actively participate in required post-approval reporting, including field alerts and adverse drug experience reports.
• Ensure compliance with all post-marketing approval requirements, including annual reports, drug listings, labeling, and pharmacopeial updates.
• Evaluate and review regulatory considerations in contracts with external partners.
• Deliver regulatory support for product recalls and communication.

Additional Responsibilities

• Engage in related regulatory duties as assigned, supporting organizational compliance and continuous improvement.

Qualifications

• Bachelor’s degree in a scientific discipline (biology, chemistry, microbiology, or pharmacy).
• Minimum 10 years’ experience in regulatory affairs within the pharmaceutical or medical products sectors; experience in quality assurance and/or compliance also considered.
• Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society is strongly preferred.
• Demonstrated experience with electronic regulatory submissions.
• Deep familiarity with USP, FDA/ICH guidelines, and relevant sections of the Code of Federal Regulations (21 CFR 111, 11, 210, and 211).
• Strong understanding of Chemistry, Manufacturing, and Controls (CMC).
• Outstanding technical writing skills with exceptional attention to detail.
• Ability to interpret complex technical documents and prepare comprehensive regulatory reports.
• Effective communicator, both written and verbal, with the capacity to build relationships across teams and at all organizational levels.
• Proficiency in MS Office Suite (Word, Excel, PowerPoint, etc.).

Why Join Us?

Be part of a dynamic, mission-driven CDMO dedicated to scientific excellence, innovation, and people-focused leadership. Our team members enjoy a comprehensive benefits package, including medical, dental, vision, and a company-matching 401(k) plan. We celebrate diversity and are committed to providing equal employment opportunities to all qualified individuals based on merit and without regard to age, disability, ethnicity, gender, marital status, race, religion, sexual orientation, or gender identity, in accordance with governing laws.

Ready to take the next step in your career and make an impact in a leading-edge pharmaceutical environment? Apply today to join a collaborative team that values integrity, quality, and growth

What happens next:

Once you apply, you’ll proceed to the next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.