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BD
San Diego, CA, United States
Job Description Summary Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions o
Job Source: BDPartnology
San Diego, CA, United States
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 ess
Job Source: PartnologyShoreline Biosciences, Inc.
San Diego, CA, United States
Company Summary: Located in San Diego, CA, Shoreline Biosciences, Inc. is focused on changing the lives of patients and families by developing safe, highly effective, and accessible allogeneic NK and macrophage cell therapies for the treatment of various serious diseases, including cancer. Shoreline was recognized by the California Life Sciences a
Job Source: Shoreline Biosciences, Inc.Crinetics Pharmaceuticals
San Diego, CA, United States
Position: Senior Director, Regulatory Affairs Location: Onsite, CA Job Id: 732 # of Openings: 0 Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with rare endocrine diseases. We were founded by a dedicated team of scientists with the simple belief that better therapies develope
Job Source: Crinetics PharmaceuticalsConfidential
San Diego, CA, United States
Executive Director, Regulatory Affairs About the Company Prominent clinical-stage biopharmaceutical company Industry Pharmaceuticals Type Public Company About the Role The Company is seeking an Executive Director of Regulatory Affairs with a focus on strategic and operational leadership. The successful candidate will be responsible for providing me
Job Source: ConfidentialImbria Pharmaceuticals
San Diego, CA, United States
Company Overview Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell’s ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor
Job Source: Imbria PharmaceuticalsImbria Pharmaceuticals
San Diego, CA, United States
Company Overview Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell’s ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor
Job Source: Imbria PharmaceuticalsAequor Technologies
San Diego, CA, United States
US Regulatory Affairs Lead SCOPE OF RESPONSIBILITIES: • He/She will be responsible for representing regulatory function to approve promotional material • He/She will be at ease working in a matrix environment and be able to navigate ambiguity to drive decision making working across regional teams DUTIES: • Work with regulatory leads through cross
Job Source: Aequor TechnologiesSan Diego, CA, United States
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:
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.
Qualifications:
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.
Working Conditions:
Travel may be required.
Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels.
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Email Alert for Associate Director Regulatory Affairs jobs in San Diego, CA, United States
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