Manager, Regulatory Affairs

The posting, as Dendreon Pharmaceuticals LLC wrote it

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.

CORE VALUES

• 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.

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,

[…]
age 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.

CA Compensation Range
$129,600 — $147,000 USD

Beware of Recruitment Scams

Please be aware of the potential for scams from individuals, organizations and internet sites that claim to represent Dendreon Pharmaceuticals in recruitment activities. We strongly recommend that you verify all communications you receive about positions at Dendreon. Any communications from Dendreon would come from an email address that ends in “@ dendreon.com ”. Dendreon will never ask candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the recruitment or offer process. Dendreon conducts a formal recruitment process for all authorized positions posted and does not conduct interviews via social media, or other third-party sites or chat services. If you are unsure about a posting or email you receive, please contact us at AskHR@dendreon.com . If you believe you are a victim of fraud, please contact your local law enforcement.