Manager, Regulatory Affairs

WHO WE ARE

At Dendreon, we’re transforming the battle against cancer with personalized immunotherapy. Our flagship product, PROVENGE® (sipuleucel-T), was the first FDA-approved immunotherapy for metastatic castrate-resistant prostate cancer, utilizing a patient’s own immune cells to fight the disease.

If you’re driven by the opportunity to make a meaningful impact on cancer patients’ lives, we invite you to join our team. With Immunotherapy Manufacturing Facilities in Seal Beach, CA, and Union City, GA, a talented team of scientific, clinical, regulatory, and corporate professionals based in Seal Beach, and a commercial organization operating across the United States, Dendreon continues to advance innovation in personalized cancer treatment.

• Put Patients First:
  Every day is an opportunity to improve the lives of those living with cancer.
• Act with Integrity:
  We commit to transparency, honesty, and always doing what’s right.
• Build Trust:
  Trust is earned through candid, open communication and a collaborative approach.
• Raise the Bar:
  We embrace continuous improvement and innovation, always striving to elevate our people.
• Drive Results:
  We are accountable to each other and deliver success together.

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 minimum 4 days per week.

• 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.

• 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,…