Manager, Regulatory Affairs.

JOB SUMMARY:  

The Manager, Regulatory Affairs (CMC) is responsible for developing and implementing regulatory strategies that support the development, approval, and lifecycle management of biologic, cell, and gene therapy products. This role leads CMC regulatory submissions, provides regulatory guidance to cross-functional teams, and serves as a key liaison with global health authorities to ensure compliance with applicable regulations and business objectives.

NOTE: This role requires on-site presence at our Seal Beach, CA location.

Responsibilities:

• Develop and execute global CMC regulatory strategies supporting product development, registration, commercialization, and lifecycle management activities for biologic, cell, and gene therapy products.
• Lead the preparation, review, and submission of regulatory applications and filings, including INDs, BLAs, NDAs, CTAs, amendments, supplements, annual reports, and other regulatory correspondence.
• Serve as the primary Regulatory Affairs representative on cross-functional teams, providing strategic guidance to R&D, Manufacturing, Quality, Supply Chain, and Technical Operations.
• Represent Regulatory Affairs in interactions with FDA and other global health authorities, including regulatory meetings, responses to inquiries, and submission-related communications.
• Evaluate and provide regulatory guidance on manufacturing changes, process improvements, product comparability, and post-approval lifecycle initiatives.
• Monitor and interpret evolving regulatory requirements, industry guidance, and emerging trends, communicating potential impacts and recommendations to stakeholders.
• Prepare, review, and maintain regulatory documentation, including labeling, BPDRs, lot distribution reports, IND safety reports, clinical and investigator documents, and other required records.
• Support regulatory inspections, audits, due diligence activities, and corrective actions arising from regulatory observations.
• Develop and maintain departmental SOPs, policies, work instructions, and regulatory processes to ensure compliance and operational efficiency.
• Mentor junior staff, consultants, and contractors, as applicable, and contribute to departmental objectives and continuous improvement initiatives.
• Perform other duties as assigned.

JOB REQUIREMENTS:

Required Experience & Education:

• Bachelor's degree in a scientific discipline or equivalent combination of education and experience.
• Minimum of 7 years of Regulatory Affairs experience in the biotechnology, biopharmaceutical, pharmaceutical, medical device, or other FDA-regulated industry.
• Minimum of 3 years of experience supporting CMC Regulatory Affairs activities and submissions.
• Experience preparing, reviewing, and submitting regulatory filings, including INDs, BLAs, NDAs, CTAs, amendments, supplements, annual reports, and regulatory correspondence.
• Working knowledge of FDA regulations, ICH guidelines, cGMP requirements, and regulatory submission processes.
• Experience developing and executing regulatory strategies supporting product development, manufacturing changes, and lifecycle management activities.
• Strong technical writing, document review, and communication skills.
• Demonstrated ability to work effectively in cross-functional teams and manage multiple priorities in a fast-paced environment.
• Experience interacting with regulatory agencies and supporting responses to regulatory inquiries.
• Proficiency with electronic document management systems and eCTD submission processes

Preferred Experience & Education:

• Advanced degree (M.S., Ph.D., Pharm.D., RAC, or equivalent) in a scientific or regulatory discipline.
• Experience supporting biologics, cell therapy, gene therapy, immunotherapy, or other advanced therapeutic products.
• Experience with global regulatory submissions and interactions with international health authorities.
• Regulatory Affairs Certification (RAC).
• Experience supporting FDA inspections, regulatory audits, and due diligence activities.
• Knowledge of post-approval change management, comparability assessments, and manufacturing process validation.
• Experience mentoring junior regulatory professionals, consultants, or contractors.
• Strong project management skills and experience leading complex cross-functional initiatives.
• Familiarity with commercial-stage biologics and lifecycle management within a biotechnology environment.

Working Conditions and Physical Requirements:

• Ability to sit or stand for extended periods of time.
• Intermittent walking.
• Finger dexterity sufficient to use a computer and to complete paperwork activities.
• Vision sufficient to use a computer, to read written materials and to complete paperwork activities.
• This role operates in a standard office setting using standard office equipment.
• Role requires frequent use of video conferencing, standard office software, and digital collaboration tools.
• Must have the ability to lift 10 – 20 lbs.
• Hearing sufficient to communicate with individuals by telephone and in person.
• Must have the ability to work in an office environment around laboratories, manufacturing areas and equipment with exposure to blood, blood products or OPIM (other potentially infectious materials) while donning required personal protective materials.