Associate Director, Regulatory Affairs

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 strong Research & Development group in Seattle, WA, and a highly skilled Commercial team across the nation, Dendreon is at the forefront of cancer treatment innovation.

• 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.

• →Oversees regulatory compliance activities and ensures organizational adherence to applicable FDA, international, and regional regulatory requirements.
• →Partners with Quality, Manufacturing, Clinical, Commercial, and Technical Operations teams to assess regulatory changes and implement appropriate operational, product, and procedural modifications.
• →Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored.
• →Establishes and maintains processes to ensure regulatory licenses, registrations, certifications, filings, and regulatory commitments are appropriately tracked, maintained, and renewed.
• →Accountable for the quality, completeness, and timely submission of regulatory applications and health authority responses.
• →Directly manages Regulatory Affairs personnel and may oversee consultants, contractors, and external regulatory partners.
• →Develops, implements, and maintains regulatory policies, procedures, and compliance monitoring processes to support regulatory adherence and operational excellence.
• →Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements.
• →Provides regulatory leadership in the investigation, assessment, and resolution of regulatory compliance issues, deviations, and corrective actions.
• →Develops materials for and leads key interactions with regulatory authorities.
• →Maintains awareness and assesses the impact of additions/changes to regulations and guidelines and evaluates relevance to company and product interests.
• →Provides leadership, coaching, performance management, and professional development for Regulatory Affairs personnel.
• →Oversees recruitment, onboarding, and development of Regulatory Affairs team members.
• →Provides strategic regulatory leadership throughout the product lifecycle, from early development through commercialization and post-marketing activities.
• →Serves as Regulatory Affairs representative on Promotional Review Committees and reviews promotional materials for regulatory compliance.
• →Supports regulatory inspection readiness activities and responses to regulatory observations and inquiries.
• →Leads preparation for and participation in FDA, EMA, NMPA, and other health authority meetings, including strategy development and briefing document preparation.
• →Leads multidisciplinary teams in the authoring of regulatory submissions such as CMC submissions, protocols, CSRs, Annual Reports to INDs /BLAs, etc.  A hands-on approach is vital.
• →Responsibilities include providing guidance, regulatory expertise, and advice to senior management and other company personnel to achieve goals for regulatory timelines, strategy, CMC, nonclinical and clinical testing.
• →Provides oversight to post-marketing activities for commercial product including biological product deviation reporting, assessment of manufacturing changes, labeling, advertising and promotional materials, etc.
• →Plans, manages, and executes regulatory activities, including submission and maintenance of US and international regulatory filings.
• →Leads global regulatory or technical initiatives or acts as a Regulatory expert in cross-functional initiatives.
• →Contributes to the development, management, and oversight of departmental budgets and resource planning activities.

• BS required; MS, PharmD, PhD, or other advanced scientific degree preferred.
• 10+ years of progressive Regulatory Affairs experience within the biotechnology, pharmaceutical, or life sciences industry, including experience leading complex regulatory submissions and cross-functional initiatives.
• 5+ years of progressive leadership experience with demonstrated success influencing cross-functional teams and driving regulatory outcomes.
• Pre- and Post-approval experience with advanced cellular therapy products is highly desired.
• Prior drug development experience.
• Experience with health authorities in China is desirable.
• Demonstrated leadership, collaboration, negotiation, and influencing skills with a proven ability to solve complex regulatory challenges.
• In-depth knowledge of FDA, cGMP and ICH regulatory requirements.
• The ability to travel domestically and internationally as needed.

• Dendron Pharmaceuticals LLC is a EEO/AA employer M/F/D/V.
• Dendreon operates in a fast-paced, patient-centric, and competitive environment.
• Team cohesiveness, direct and specific communication, and independent problem-solving are essential to succeed in this position.
• Some travel required.
• While performing the duties of this job, the employee is regularly required to sit, stand, walk, and use hands to operate a computer keyboard, mouse, and mobile phone.