Sr Regulatory Affairs Associate
In the US alone, a patient dies every 5 minutes from a disease of hematopoietic (blood and immune cell) origin. In addition to this human cost, over $100B is spent annually on the care of these patients.
Headquartered in Menlo Park, Orca Biosystems is a clinical-stage cell therapy company dedicated to delivering curative medicine to these patients. Based on technology developed in Irv Weissman’s lab, Orca Biosystems has developed a pipeline of proprietary technologies that have the potential to impact over 100 malignant and auto-immune diseases. Orca Biosystems has assembled a team of world-leading experts and technologists to execute this vision.
The Sr Regulatory Affairs Associate is a critical hands-on position and is responsible for leading and executing on all regulatory activities within the organization.
Responsibilities & Oversight
- Responsible for the coordination, preparation and review of filings and maintenance of regulatory submissions.
- Leads hands-on activities and coordination in preparation and authorship of regulatory documents in clinical programs, CMC, process improvement, and laboratory quality.
- Accountable for regulatory project deliverables to completion, ensuring appropriate follow-up of correspondence, such as re-submissions.
- Supports the clinical team and the CMO in interactions with reviewers from the FDA and other health authorities. Coordinates activities for meetings with FDA, and other regulatory authorities.
- Provides regulatory strategic input to the clinical team and participates in operational activities in projects including, but not limited to, regulatory requirements for clinical studies, general GMP/CMC regulatory strategies and marketing approval in domestic and international markets, regulatory development plans, risk assessments and critical issue management.
- Maintains current awareness of the global regulatory environment and assesses impact of changes on business and product development programs. Facilitates policy and development of standard interpretation of global regulation.
- Builds productive partnerships with Clinical Operations, Manufacturing, and other clinical team stakeholders to ensure that development goals are met through the sharing of knowledge, expertise and the provision of appropriate resources.
- Interprets and communicates regulatory expectations to internal and external stakeholders (including partners, CROs, CMOs, consultants, and contractors) in order to execute program objectives in compliance with applicable regulations. Coordinates with cross functional teams to define contributions to submissions.
- Ensures compliance with health authority regulations. Develops and implements department policies, processes and SOPs. Oversees implementation of regulatory strategy and activities needed to secure approval of new drugs.
- Interprets preclinical and clinical results, developing them into sound regulatory strategies.
Ideal Educational Requirements and Background
- 4 years’ experience in regulatory affairs and GxP experience in the biotechnology or pharmaceutical industry.
- Bachelor’s degree in a related discipline.
- Regulatory affairs experience in companies developing cell therapy, immunotherapy, CAR T therapy or gene therapy is ideal; a background in biologics is preferred.
- Regulatory affairs experience in companies developing technologies or therapeutics for bone marrow transplantations and/or oncology is ideal. A background in immunology and/or autoimmune diseases is also ideal.
Preferred Regulatory Background and Experience
- Demonstrated experience in preparing new IND/CTA and/or marketing application submissions. Excellent technical writing skills and experience.
- Demonstrated knowledge of regulatory aspects of biologics, cell therapy, gene therapy or CAR T cell therapy is highly desirable.
- Experience in hematology oncology and focus on immunotherapy for cancer is highly desirable.
- Demonstrated knowledge of the regulatory requirements in the design and conduct of clinical trials, drug development, and approval process, with a focus on IND and BLA processes.
- Previous experience in translational and early development programs in oncology and hematology (e.g. successful INDs, FDA advisory committee meetings, oral explanations, preNDA/BLAs, international submissions, etc.).
- Demonstrated ability to interpret and stay current with FDA and international regulatory agency regulations and guidelines, with a successful record of development and implementation of the global regulatory strategy.
- Current knowledge of GxPs.
- Experience with FDA interactions, with a proven track in biologics approval for oncology indications.
- Familiar with eCTD and epublishing systems.
- Creative and strategic view in developing programs in immunology and oncology and act as an advisor to the clinical team in regulatory and CMC quality.
- Able to articulate complex regulatory CMC issues and support global development and commercialization of early and late stage programs.
- Highly detail-oriented, independent, self-motivated and hands-on.
- Well organized and able to work under tight deadlines.
- Demonstrated strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment.
- Excellent communication and organizational skills.
- Excellent public speaking and presentation skills.
- Ability to work in a collegial manner within a highly collaborative culture.
- Tolerant, respectful and empathetic of others.
- Ability to perform a variety of complicated tasks with a wide degree of creativity and latitude.