Director, Regulatory Affairs
Regulatory Affairs | South San Francisco, CA | Full Time
About Allogene Therapeutics, Inc:
Allogene Therapeutics is a clinical-stage biotechnology company with a single-minded focus on pioneering the development of investigational allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer. Led by world-class management with significant experience in cell therapy, our fully integrated, in-house team of researchers is dedicated to discovery and translational research, development, and cell manufacturing.
At Allogene, we are developing a pipeline of off-the-shelf CAR T cell candidates, with the goal of delivering readily available cell therapy faster, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.
Allogene is seeking a Director of Regulatory Affairs within the Regulatory Strategy group who will manage worldwide interactions and negotiations with regulatory agencies and marketing partners in support of investigational studies, product registrations, and commercial products. This individual will be a key member of project teams and teams responsible for evaluation of product concepts. Reporting to the Head of Regulatory Affairs, this individual will be responsible for assuring the regulatory strategy is aligned with Health Authority requirements and regulatory submissions are on time and of high quality.
Responsibilities include, but are not limited to:
- Lead program teams in preparing regulatory submissions including briefing documents, IND/CTA/BLA filings, and marketing applications
- Oversee preparation of responses to all regulatory authority queries
- Plan and lead meeting 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 CMC team. Serve as primary regulatory representative (for assigned projects) at internal meetings as well as at meetings with regulatory agencies for all clinical related issues
- Maintain detailed knowledge of global regulatory environment relevant for cell therapies and regenerative medicine including accelerated review programs. Communicate changing regulatory agency requirements; support pertinant regulatory intelligence per needs of programs
- Collaborate with external consultants, clinicians, CROs to provide regulatory guidance.
- Escalate issues to Management that affect registration, regulatory compliance and continued lifecycle management of the product
- 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 Orphan Drug Designation, BTD and RMAT is preferred
- Manage contract staff and vendors as needed to support regulatory activities
- Interpersonal skills that promote a collaborative and productive lab environment
- Effective and efficient written and oral communication skills
- Candidates must be authorized to work in the U.S
Position Requirements & Experience:
- A minimum of a Bachelor's and or undergraduate degree in biological, pharmaceutical, chemical or engineering sciences is required.
- 10+ years of experience 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
- Experience in biologics is preferred
- Experience with regulations or product development in gene therapy, such as CAR-Ts, AAVs, or CRISPR technology etc. is highly preferred.
- 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
- Ability to work independently and as part of a team
As an equal opportunity employer, Allogene is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment and internships designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.