- Contribute to strategic planning and implementation of clinical regulatory activities required to initiate and conduct clinical trials and to seek marketing authorization.
- Interact with the FDA, EMA, PMDA, and other regulatory agencies to seek scientific and regulatory advice and obtain required approvals.
- Provide strong cross-functional leadership for global filings including authoring/reviewing sections of IND/CTA, NDA/BLA/MAA, and other global submission documents in support of clinical trials and marketing applications, as well as their amendments, in conformance with local regulatory requirements.
- Develop and implement cross-functional department policies, processes, work instructions, and standard operating procedures.
- Provide regulatory leadership for due diligence activities, partnering activities, and product/company integrations.
- Support the development and implementation of innovative systems, tools, and streamlined processes to create and maintain high-quality regulatory submissions and manage a state-of-the-art regulatory intelligence and knowledge management approach.
- Ensure inspection readiness efforts for regulatory activities and files.
- Participate in preparing regulatory budgets and managing vendors.
- Maintain current expertise in regulatory trends and operations.
- Participate as needed in technical discussions and collaborate with corresponding groups at Health Authorities to advance Regulatory Science.
- Bachelor of Science with at least eight (8) years of progressive and relevant experience. Master's degree or PhD preferred.
- Regulatory experience with clearing INDs and CTAs and gaining approvals of NDAs, MAAs, BLAs and/or sBLAs.
- Demonstrated proficiencies contributing to successful health authority meetings.
- Experience with breakthrough, RMAT, and orphan designation submissions; experience with companion diagnostic submissions (IDE/PMA) a plus.
- Experience with cell and gene therapy products/complex biological products.
- Experience with autoimmune products and interacting with FDA CBER and EMA; additional experience with oncology products a plus.
- Experience in leading multidisciplinary teams desired to deliver cross-functional regulatory deliverables.
- Strong knowledge in clinical and nonclinical regulatory science.
- Knowledgeable regarding global regulatory submission standards and publishing best practices.
- Ability and interest in rolling up their sleeves to perform hands-on regulatory activities while simultaneously building the department to ensure successful scalability as the programs grow.
- Ability to influence without direct authority.
- Travel may be required.
- Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels.
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Associate Director Regulatory Affairs - San Diego, United States - Partnology
Description
An exciting and innovative clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer and autoimmune disease is looking for an Associate Director in Regulatory Affairs to oversee and contribute to the strategic planning and execution of clinical regulatory activities essential for initiating and conducting clinical trials and securing marketing authorization. This role involves extensive interaction with regulatory agencies such as the FDA, EMA, and PMDA, seeking scientific advice and approvals, and provides cross-functional leadership for global filings, ensuring compliance with local regulatory requirements and authoring/reviewing submission documents for regulatory applications. The ideal candidate will have experience leading regulatory teams and a successful record of approved regulatory submissions. This is a full-time, exempt position located at our corporate headquarters in San Diego, CA.
Responsibilities:
Qualifications:
Working Conditions:
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