Director, Regulatory Affairs
Regulatory Affairs | South San Francisco, CA | Full Time
Tolerion is a clinical-stage biopharmaceutical company, located in South San Francisco, with a product portfolio of multiple candidates addressing multiple therapeutic areas. Our product candidates come from our proprietary therapeutic platform which selectively eliminates specific, harmful immune responses while leaving the rest of the immune system intact, a state known as “antigen-specific tolerance." We expect this targeted and selective approach will lead to improved efficacy, safety and tolerability relative to current therapies. With this platform we have created a pipeline of novel product candidates to treat autoimmune diseases in a fundamentally new manner by addressing the root cause of an aberrant immune response. Our lead product candidate, TOL-3021 for the treatment for type 1 diabetes, has completed a Phase 2a clinical trial which showed a promising safety profile and early signals of efficacy. We are currently moving TOL-3021 into advanced clinical development in pursuit of registration. Beyond TOL-3021, we have two additional named clinical candidates selected for advancement into the clinic to treat two additional autoimmune disorders.
Separate from the area of treating autoimmune disease, we have adapted our technology to deliver adjunct solutions capable of inducing specific tolerance in gene therapy settings. Too often promising gene therapy solutions are plagued by immunogenicity that becomes limiting. We have several preclinical programs that demonstrate we can induce immune tolerance in a gene therapy setting, enabling improved efficacy and safety profiles. We own all worldwide marketing, distribution and manufacturing rights to each of our product candidates.
The Director of Regulatory Affairs will provide regulatory strategy and operational support for Tolerion’s pipeline products and provide strategic regulatory input to research, clinical and manufacturing/CMC teams. Reporting to the Chief Medical Officer, this individual will be responsible for assuring the regulatory strategy is aligned with FDA and other Health Authority requirements and regulatory submissions are on time and of high quality.
- As a member of the project teams, provide strategic regulatory guidance for global development and registration programs (e.g., INDs, NDAs and MAAs)
- Assess and communicate regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines
- Primary regulatory representative (for assigned projects) at internal meetings as well as at meetings with regulatory agencies for all Clinical and CMC related issues
- Compile, review, approve and submit CMC and marketing registration applications, supplements and variations
- Respond to regulatory questions from various regulatory authorities, working in collaboration with SME’s in Research, Clinical, Manufacturing, QC/QA, global supply chain and other business partners
- Manage and ensure compliance with all reporting requirements, including annual and periodic reports
- Manage contract staff and vendors as needed to support regulatory activities
- Other duties as assigned
Requirements & Experience:
- Bachelor’s degree required, advanced degree preferred with at least 10 years regulatory affairs experience
- Experience in building, leading and managing a clinical operation function within the context of a science-driven organization
- Experience in filing regulatory submissions from early development to pre- and post-approval submissions and product lifecycle management, ideally in the area of Gene and Cell Therapy
- Detailed working knowledge of regulatory guidelines and regulations (US and international)
- Regulatory experience supporting both development projects and marketed products
- First-hand knowledge and experience of FDA CMC regulatory submissions
- Experience with Orphan Drug Designation, BTD and RMAT is desirable
- 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
- Ability to work in a fast-paced, start-up environment
- 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
- Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment
- Candidates must be authorized to work in the U.S.
As an equal opportunity employer, Tolerion 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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process contact the careers email at www.tolerion.bio for assistance.
For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ poster.
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