Director/Senior Director, Regulatory Affairs
Clinical Development | Emeryville, CA | Full Time
Eureka Therapeutics is a privately-held biotechnology company focused on developing novel T cell-based immunotherapies for hematological malignancies and solid tumors. Our unique platform is aimed at developing safe and effective genetically engineered T cells against surface cancer antigens as well as TCR-mimic antibodies, which recognize previously inaccessible cancer antigens specific for solid tumors. We have built strong pipelines of innovative drugs, with the most advanced candidates in clinical stage. In addition to our internal drug discovery programs, Eureka has ongoing partnerships with several major pharma and academic centers of excellence. To learn more about us, please visit our website at www.eurekatherapeutics.com.
The Director/Senior Director, Regulatory Affairs will be reporting directly to the Chief Medical Officer (CMO) and will be responsible for execution of all regulatory activities within the organization.
Responsibilities include, but are not limited to:
- Responsible for the coordination, preparation, review and timely filing and maintenance of regulatory submissions (INDs, DMFs, CTAs, amendments, safety reports, annual updates, orphan drug applications, expedited pathways, pre-meeting briefing packages to the FDA, and, as required, to the international, regulatory authorities).
- Reviews Chemistry, Manufacturing, and Controls (CMC), clinical and preclinical sections of IND/CTA, NDA/BLA/MAA, and other global submission documents in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements.
- Accountable towards the CMO and clinical team for deliverables of regulatory projects to completion, ensuring appropriate followup of correspondence, such as re-submissions.
- Supports the clinical team and the CMO in interactions with reviewers from FDA and other health authorities. Coordinates activities for meetings with FDA, and other regulatory authorities.
- Leads the handson preparation and coordination in preparation and authorship of regulatory documents in clinical programs, CMC quality, process improvement, and laboratory quality.
- 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 and risk assessments and critical issue management.
- Maintains awareness of global regulatory environment and assesses impact of changes on business and product development programs. Facilitates policy and development of standard interpretation of global regulation.
- Uses extensive knowledge of US, and international regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects.
- Builds 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 crossfunctional 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 and develop those into sound regulatory positions and strategy.
- Develops and maintains cooperative relationships with external vendors and regulatory health authorities.
- Ensures that budgets and schedules meet corporate timelines.
- Other duties as assigned.
- A minimum of 10 years of regulatory and GxP experience in the biotechnology or pharmaceutical industry including product approval/ launch, with >8 years in leadership position.
- Advanced degree in a science related field (PhD, PharmD, etc.)
- Demonstrated experience in preparing new IND/CTA and/or marketing application submissions.
- Demonstrated success in submission and approval of BLAs.
- Demonstrated knowledge of regulatory aspects of biologics/ gene/ cell/ CAR T cell therapy, CMC, and quality assurance.
- Extensive experience in Hematology Oncology and focus on immunotherapy for cancer. Experience in cell/gene therapy 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.
- Must have previous experience in translational/ early development programs in oncology and hematology (e.g. successful IND and BLA submissions, FDA advisory committee meetings, oral explanations, preNDA/BLA, EOP2 meetings, international submission, etc.).
- Demonstrated ability to interpret and stay current with FDA and other international regulatory agency regulations and guidelines, with a successful record of development and implementation of the global regulatory strategy.
- Current knowledge and understanding of GxPs (GCPs, GLPs, GMPs).
- Extensive experience with FDA interactions, with proven track in biologics approval for oncology indications. Cell therapy experience desired.
- Familiar with eCTD and epublishing systems.
- Experience in orphan drug development and approvals desired.
- Creative and strategic view in developing programs in immunology/ 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.
- Experience in quality assurance, able and willing to contribute in setting up the quality system for clinical development including preparation of SOPs and gap analysis.
- Firsthand experience in CMC quality assurance and in GCP quality.
- Experience in safety reporting and working knowledge of pharmacovigilance.
- Intimate knowledge of safety reporting process.
- Able to manage the safety reporting process as needed.
Personal and Leadership Competencies
- Has a hands-on approach to preparation and submission of regulatory documents in a timely fashion. Project manages the regulatory and quality activities.
- Aspires to work in a matrix environment within the clinical team.
- Has the flexibility and willingness to solve problems that fall outside of immediate area of expertise.
- Excellent organizational, writing, communication, and time management skills needed to manage multiple ongoing projects simultaneously.
- Work independently in an interdisciplinary, fast-paced, often changing environment.
- Results driven, collaborative, and team-oriented.
- Strategic leadership skills, in high profile, complex or novel development programs.
- Ability to think strategically and critically evaluate risks to regulatory activities.
- Must have strong negotiation skills with vendors.
All submissions will be evaluated, and interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for available positions for a period of one year.
Eureka Therapeutics is an equal opportunity employer and does not discriminate against otherwise qualified applicants on the basis of race, religion, color, sex, age, ancestry, national origin, marital status, veteran status, medical conditions, handicap, physical or mental disability, sexual orientation, or any other status protected by law.
No phone calls please and no agencies or recruiters.