Director, Regulatory Affairs
BlossomHill Therapeutics, Inc.
BlossomHill Therapeutics, Inc. is seeking a Director, Regulatory Affairs, onsite in BlossomHill's San Diego office, to lead worldwide regulatory strategies and manage submissions for our clinical programs. In this role you will author and coordinate regulatory documents, respond to Health Authority questions, and collaborate with R&D, safety, biostatistics, and CROs to ensure timely, compliant filings and strategic intelligence. #J-18808-Ljbffr
$150k - $195k
...paths as we move toward a common goal of elevating science and service for rare patients.Position Summary:The Associate Director, CMC Regulatory Affairs is responsible for providing strategic and operational regulatory leadership for Chemistry, Manufacturing, and...SuggestedFull timeTemporary workRemote work- JOB SUMMARYThe Associate Director/Director of Regulatory Affairs - Chemistry, Manufacturing and Controls (CMC) will lead global CMC regulatory strategy and execution across Iambic's development programs. The role will prepare and oversee high-quality CMC content for regulatory...SuggestedWork at officeFlexible hours
$210k - $240k
...are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The PositionThe Director of Regulatory Affairs is Arrowhead’s Labeling lead, who drives cross-functional development and execution of global regulatory labeling...Suggested$150k - $195k
...science and service for rare patients.Position Summary: The Associate Director, Regulatory Project Manager (RPM) at Travere Therapeutics is responsible for leading and coordinating global regulatory affairs activities to ensure compliance with health authority requirements...SuggestedFull timeTemporary workRemote workShift work- ...kozmetickesluzby.vecnakraska.sk - Jobboard is seeking an Associate Director of Regulatory Affairs to provide regulatory support for medical device systems at our San Diego site. This role involves developing regulatory strategies for new product submissions and handling...SuggestedRemote workFlexible hours
$240k - $275k
San Diego, CAClinical - Regulatory /Full-Time /HybridThe Senior Director, Global Regulatory Affairs will provide strategic regulatory leadership across Janux’s clinical-stage oncology pipeline, supporting programs from early development through registration. This individual...Full timeSummer workWork at officeRemote workRelocationRelocation packageShift work- ...flexibility to work 4 days at our San Diego site and Friday remotely. Summary of Job Responsibilities The Associate Director of Regulatory Affairs will provide regulatory support for medical device systems within infusion technologies. The role includes developing...Work experience placementWork at officeRemote work
$189.7k - $237.1k
...days per week on average Position Summary Join Acadia as the Director, Regulatory CMC and play a critical role in advancing innovative small... ...world. Primary Responsibilities Manages the CMC regulatory affairs activities for marketed products and compounds in development...Work at officeLocal areaRemote workWorldwideNight shift3 days per week- ...Artiva Biotherapeutics Inc. is seeking a Director/Senior Director of Regulatory Operations to build and scale regulatory operations for NK cell therapies. This role owns end-to-end submission planning, global filings, and the regulatory information management platform...Remote work
$209.05k - $249.04k
..., a non‑covalent, pan‑KRAS inhibitor for treatment of diverse KRAS‑mutant tumors. BlossomHill Therapeutics is seeking a Director, Regulatory Affairs, reporting to the Executive Director, Regulatory Affairs, to work with cross‑functional teams to develop worldwide regulatory...Work at officeLocal areaWorldwide$190k - $210k
...Description The Director of Regulatory Affairs (RA Director) will manage, evaluate, and execute regulatory projects consistent with company goals, and will contribute to the development of global regulatory strategy. This position will directly support the drafting and...For contractorsWork at officeLocal area- ...Director, Regulatory CMC Join Acadia as the Director, Regulatory CMC and play a critical role in advancing innovative small molecule therapies... ...Primary Responsibilities Manages the CMC regulatory affairs activities for marketed products and compounds in...Work at officeRemote workWorldwideNight shift
- A biotechnology consulting firm is seeking a Regulatory Affairs Consultant to support projects with about 10-20 hours of work per week. This remote position requires expertise in regulatory strategy development, especially in relation to in-silico modeling. Candidates...Remote work10 hours per week
$189.7k - $237.1k
...Position Summary Director, Regulatory CMC. Hybrid role (office ~3 days/week) in San Diego, CA; San Francisco, CA; or Princeton, NJ. Primary Responsibilities Manage CMC regulatory affairs for marketed products and compounds in development (US and ex-US). Coordinate with...Work at office3 days per week- ...Executive Director, Regulatory Affairs About the Company Esteemed company developing medicines for inflammatory & autoimmune diseases Industry Biotechnology Type Privately Held, VC-backed Founded 2018 Employees 51-200 Funding $101-$200 million...
- ...creates, acquires and finances companies that develop and commercialize pharmaceutical products. Position Summary The Director, Regulatory Affairs will support the development and execution of domestic and international regulatory strategy for Codera. This position involves...
- Stryker Corporation is looking for a Director of Regulatory Affairs to lead regulatory strategy and compliance efforts. This fully remote position involves coordination with FDA and overseeing regulatory submissions in the pharma/biotech field. Candidates should have extensive...Remote job
$210k - $240k
...intersection of healthcare and technology, translating breakthrough research into real-world, safety-critical systems. Senior Director, Regulatory Affairs Location: San Diego, California (Onsite) Department: Regulatory Reports to: VP, Regulatory and Quality...Full timeTemporary workInternshipFlexible hours- ...biopharmaceutical organization is seeking an experienced Executive Director, Regulatory Strategy to provide strategic leadership across a diverse... ....Ideal BackgroundExtensive experience in regulatory affairs within the biotechnology, pharmaceutical, or life sciences industry...
$170k - $300k
...on LinkedIn, X, Instagram, and YouTube. Job Description:As the Director of SOX Compliance, you will build, lead, and continuously... ...drive remediation efforts through successful closure.Monitor regulatory developments and evolving best practices to continuously enhance...Full timeTemporary workPart timeWorldwide$116k - $151k
...forge new paths as we move toward a common goal of elevating science and service for rare patients.Position Summary:The Manager, Regulatory Affairs provides regulatory leadership and execution support for late-stage development programs and contributes to the...Full timeContract workTemporary workRemote work$154.4k - $337.7k
...there’s nowhere like RSM.RSM is looking for a dynamic Managing Director to join our assurance team. You will have the opportunity to... ...proficiency in US GAAP, US GAAS, and other applicable professional and regulatory standards.Demonstrated ability to apply professional judgment,...Full timeWork experience placementInternshipLocal area$94k - $125k
...Compliance Officer’s primary compliance presence in San Diego, you’ll play an important role in helping advisors navigate an evolving regulatory environment, identify and mitigate risk, and maintain strong compliance standards. This is a highly collaborative role that...- ...Travere Therapeutics in San Diego seeks an Associate Director, Legal-Compliance to lead the healthcare compliance program. You will plan... ...healthcare laws, collaboration across Commercial, Medical Affairs, and external teams, and guiding AI-enabled compliance initiatives...
$132k - $172k
...as we move toward a common goal of elevating science and service for rare patients.Position Summary:The Senior Manager, CMC Regulatory Affairs is responsible for providing strategic and operational regulatory leadership for Chemistry, Manufacturing, and Controls (CMC)...Full timeTemporary workRemote work- ...escalating appropriately.Excellent collaboration skills in a cross-functional environment, including Legal-Compliance, Commercial, Medical Affairs, Patient Advocacy, Finance, IT, and external vendors.Strong drafting and editing skills in Word, PowerPoint, Excel, and similar...
$132k - $172k
...as we move toward a common goal of elevating science and service for rare patients.Position Summary:The Senior Manager, CMC Regulatory Affairs is responsible for providing strategic and operational regulatory leadership for Chemistry, Manufacturing, and Controls (CMC)...Full timeTemporary workRemote workWorldwide$101.81k - $127.26k
SOLV Energy is a leading provider of infrastructure services to the power industry, designing, building and maintaining utility scale solar, battery storage and high voltage substation projects nationwide.Job Description Summary:This role can either be remote or based full...Full timeContract workWork at officeRemote work$246.98k - $299.29k
...lives. Read more: careers.bms.com/working-with-us.The GRS-CMC Director is responsible for overseeing management of multiple development... .... Develop and communicate strategic direction based on global regulatory guidelines and experience. Seeks opportunities for external...Hourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work- ...Regulatory Affairs ManagerCorDx Inc. is seeking an experienced Regulatory Affairs Manager to support the development, registration, and lifecycle management of in vitro diagnostic (IVD) medical devices in the United States.The Regulatory Affairs Manager will lead regulatory...
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