Vice President, Regulatory (24002-B-615-MED)

WHO WE ARE

Arsenal Biosciences Inc. is a clinical-stage programmable cell therapy company engineering advanced CAR T-cell therapies for solid tumors. We seek a talented and experienced Vice President, Regulatory to work remote based in our South San Francisco office. 

ArsenalBio’s mission and purpose are very clear: defeat cancer. With our programmable and computationally driven approach, our team is engineering medicines to attack cancer’s inherent multifaceted nature and overcome the challenges of addressing solid tumors with cell therapy.

Driven by a collective of diverse experts across multi-scientific disciplines and clinical and manufacturing expertise, we are united in our purpose to develop the optimal medicines for improving patients’ lives.

This means you’ll have the opportunity to work with the best talent in the field of cell therapy and be part of ONE TEAM, which advances therapies for patients who need it most.

The Vice President of Regulatory will spearhead all regulatory affairs for drug product development, driving both clinical and CMC (Chemistry, Manufacturing, and Controls) regulatory strategies. This influential leader will be at the forefront of shaping and executing regulatory pathways, ensuring compliance while advancing innovative therapies through the approval process. With a focus on both strategic vision and operational precision, this role will also provide dynamic leadership to the Regulatory team, fostering an environment of excellence and cross-functional collaboration. Reporting directly to the Chief Medical Officer within the Medical Sciences department, the VP of Regulatory will be a key architect in guiding the company’s success in navigating the complex regulatory landscape of drug development.

• Lead program teams in preparing regulatory submissions including briefing documents, INTERACT/IND/CTA/BLA filings, and marketing applications
• Oversee preparation of responses to all regulatory authority queries
• Plan and lead meetings with regulatory authorities, including end-of-phase 1/2 meetings.
• Manage critical clinical regulatory timelines and work with team members to resolve issues related to non-clinical studies, and clinical development and work in partnership with the CMC team. Serve as primary regulatory representative on assigned projects at internal meetings as well as at meetings with regulatory agencies for all clinical and CMC-related issues
• Maintain detailed knowledge of the global regulatory environment relevant to cell therapies and regenerative medicine including accelerated review programs. 
• Communicate changing regulatory agency requirements; support pertinent regulatory intelligence per needs of programs
• Collaborate with external consultants, clinicians, and CROs to provide regulatory guidance.
• Experience with Orphan Drug Designation, BTD, and RMAT is preferred
• Experience with companion diagnostics and real-world evidence studies is preferred
• Manage contract staff and vendors as needed to support regulatory activities

• A minimum of a Bachelor's and or undergraduate degree in biological, pharmaceutical, chemical or engineering sciences is required.
• 15+ years of experience, at least 10+ years in regulatory affairs, inclusive of postgraduate education and/or Advanced scientific degree preferred in the sciences, or health-related field
• Knowledge of EU and FDA regulations is required. Experience in filing regulatory submissions from early development to pre and post-approval submissions and product lifecycle management in the area of Cell Therapy
• Strong knowledge of eCTD elements and structure and regulatory writing skills
• Demonstrated knowledge of regulatory requirements in the design and conduct of clinical trials, including preparation of regulatory submissions
• Experience with regulations or product development in gene therapy, such as CAR-Ts, AAVs, or CRISPR technology etc. is highly preferred
• Demonstrated enterprise leadership skills and ability to build an experienced regulatory affairs team
• Ability to work in a fast-paced, start-up environment
• Experience directly writing submission documents that support clinical trials, marketing applications, and lifecycle management is highly preferred
• Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously
• Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines
• Effective and efficient written and oral communication skills
• Candidates must be authorized to work in the U.S
• Ability to work independently and as part of a team

BENEFITS AND PAY

ArsenalBio has a generous and comprehensive benefits package that includes but is not limited to medical, dental, and vision as well as mental health resources, virtual and telehealth options, coaching, infertility treatment, parental leave and health savings accounts. We also offer flexible work schedules and flexible time off, which includes two extra “Arsenal Days of Rest” every quarter for employees to recharge. 

Our people-first culture fosters a deep appreciation for humanity, both in the people we endeavor to serve as well as each other. We are proud to work for a company that is driven by diversity in experiences, ideas and interests, and one that empowers us in an environment that embraces both unity and inclusivity.

We have robust tools to help employees take control of their career paths and grow into their best selves. ArsenalBio believes in investing in the well-being of our employees - both at work and at home, as our people are our greatest asset. They bring scientific talents in molecular biology, immunology, pharmacology, protein chemistry, computational biology, automation, genome engineering, software and other fields to make the future happen now.

We are committed to hiring the best talent from diverse backgrounds. A diverse workforce engenders richness of thought, creativity and discovery. We invite individuals who embrace intellectual achievement to bring their unique personal and professional journeys and together we will build transformative cell therapies for cancer patients.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

The estimated base salary for the preferred primary location of the San Francisco Bay area ranges from $285,700-350,000.Salary ranges for other locations may vary.  Base pay offered may vary based on job related knowledge, experience, education, and location.  In addition to these factors, we believe in the importance of pay equity and consider internal equity of our current employees as part of any final offer.

To all recruitment agencies: ArsenalBio does not accept agency resumes. Please do not forward resumes to our jobs alias, or ArsenalBio employees. ArsenalBio is not responsible for any fees related to unsolicited resumes.

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