Global Regulatory Ops Director: AI-Enabled Submissions
Scorpion Therapeutics
Scorpion Therapeutics is seeking an experienced leader in Regulatory Operations based in San Diego, California. The candidate will oversee global regulatory submissions and optimize regulatory systems/tools. Responsibilities include leading regulatory operations, ensuring compliance with standards, and managing cross-functional partnerships. Ideal candidates should have over 12 years of experience in regulatory affairs and a bachelor's degree in life sciences. Competitive benefits include a discretionary bonus, stock options, and comprehensive medical insurance. #J-18808-Ljbffr
- ...Neurocrine Biosciences is seeking a Regulatory Affairs Leader responsible for overseeing Regulatory CMC for commercial products. Ideal... ...applications and involves strategic oversight of regulatory submissions. A strong background in FDA and EMA regulations is essential,...Suggested
$132.7k - $182k
...Scorpion Therapeutics is seeking a Regulatory Affairs professional to manage CMC activities for development and marketed projects. The... ...skills. With responsibilities including regulatory submissions, compliance assurance, and cross-department collaboration, applicants...Suggested$180k - $210k
...nonprofit research institute in San Diego seeks a Director of Regulatory Affairs to guide regulatory strategies and management of submissions. Candidates should have over 12 years of... ...include leading interactions with global health authorities, overseeing compliance,...Suggested$132.7k - $182k
...Neurocrine Biosciences is seeking a CMC Regulatory Affairs Manager in San Diego, California. This role involves overseeing regulatory activities for development and marketed projects, managing submissions, and ensuring compliance with government regulations. The ideal...Suggested$240k - $275k
...The Senior Director, Global Regulatory Affairs will provide strategic regulatory... ...teams, driving alignment and enabling timely, high-quality decision... ...Regulation (CTR) and CTA submissions. Serve as the primary regulatory... ...artificial intelligence (AI) tools to support parts of...SuggestedFull timeSummer workWork at officeRemote workRelocation packageMonday to FridayShift work- ...CorDx in San Diego, California is seeking an Associate Regulatory Affairs Manager to support regulatory document submissions for medical devices and IVD products. The ideal candidate will have a master's degree and 4-6 years of relevant experience, including 510(k) submissions...
$228k - $245k
...A biotechnology firm is seeking a Director of Global Regulatory Affairs in San Diego. This role involves developing and executing regulatory strategies to support clinical programs and interaction with global regulatory agencies. Candidates should have a BS in life sciences...$228k - $245k
...Overview The Director, Global Regulatory Affairs will play a critical role in developing and implementing regulatory strategies to support the... ...sub-teams for one or more programs. Lead the preparation, submission, and maintenance of regulatory filings (INDs, NDAs, BLAs,...Full timeSummer workWork at officeRemote workRelocation packageMonday to Friday- ...Fate Therapeutics, Inc. is seeking a Director, Regulatory Affairs to manage global clinical regulatory activities in innovative biotechnology programs. This role includes overseeing IND submissions, ensuring FDA compliance, and collaborating with cross-functional teams...Full time
- ...Director of Engineering, Strategic Initiatives & Technology Enablement Petco is seeking a strategic technology leader to drive high-impact initiatives across engineering... ...the organization implement and scale practical AI-enabled solutions that improve customer...
$194.6k - $291.9k
...through in-store adoption events. Director, Technology Enablement & Product Innovation Role Overview... ...opportunities to leverage technology, data, and AI to solve business challenges and... ...be subject to variation based on regulatory minimum wage requirements. Actual pay...Minimum wageLocal areaNight shift$180k - $210k
...transformative team. POSITION TITLE Director of Regulatory Affairs POSITION SUMMARY... ...will develop and execute global regulatory strategy,... ...responsible for regulatory submissions (including INDs), regulatory... ...Design regulatory pathways to enable efficient progression from...Flexible hours$135.1k - $225.1k
...NASDAQ DXCM) is a pioneer and global leader in continuous glucose... ...commercial, medical/clinical, regulatory, legal, and HR teams to... ...accurate capture, validation, and submission of reportable HCP transfers of... ...may be made to enable individuals with disabilities...Work at officeHome officeFlexible hours$90k - $150k
...the limits of innovation and supply in global health. With over 2,100 employees across... ...seeking a highly motivated and experienced Regulatory Specialist to join our Regulatory... ...experience with 510(k) preparation and submissions to ensure compliance with FDA and other...Full time$172k - $250k
...Grant Thornton is seeking a Director of Information Security Audit & Compliance... ...Compliance to lead and scale a global audit and compliance practice.... ...combines deep audit and regulatory expertise with strong operational leadership, enabling the organization to meet regulatory...InternshipSeasonal workWork at officeLocal areaFlexible hours3 days per week- ...Senior Director, Finance Data Strategy page is loaded##... ...Income aims to be a globally recognized leader in the... ...advanced analytics/AI readiness. This position... ..., automation, and AI enablement.* Own the Finance data... ...Finance data meets audit, regulatory, and public‐company...
$154k - $193k
...Summary The Associate Director, Regulatory Affairs Project Planning & Coordination... ...that facilitate how the Global Regulatory Affairs... ...involved in planning of regulatory submission timelines, compliance and... ...dashboards and scorecards to enable visibility, risk...Work at officeLocal areaRemote workNight shift3 days per week$150k - $194k
...Associate Director, Regulatory Affairs CMC page is loaded## Associate Director... ...and prepare regulatory submissions (authoring, timeline planning... ...and implementing global regulatory strategies. Establishes... ...accommodations may be made to enable individuals with...Contract workLocal area- ...the limits of innovation and supply in global health. With over 2,100 employees across... ...Job Type: Full time Job Title: Associate Regulatory Affairs Manager Location: Onsite - San Diego... ...support the development, review, and submission of regulatory documents for medical...Full timeWork at officeFlexible hours
$220k - $245k
...Fate Therapeutic is seeking a strategic and experienced Director, Regulatory Affairs to lead global clinical regulatory activities supporting innovative... ...strategy, and drive successful regulatory submissions and approvals. The ideal candidate will have extensive...Full time$240k - $265k
...focusing on oral small molecule therapies. The Senior Director of Regulatory Affairs leads global regulatory activities and manages personnel for IND/... ...iPSP/PIP, NDA/MAA). Provide oversight of regulatory submissions vendors to assure technical accuracy, compliance, completeness...Work at officeRemote workFlexible hours$110k - $165k
...growing compliance function by providing regulatory oversight, program review, and advisory... ...processes to ensure timely and accurate submissions to regulators to include oversight of statistical... ...accommodations will be considered that enable an employee with a disability to enjoy...Live inLocal areaFlexible hours$187.9k - $256k
...the Role: Responsible for the strategic Regulatory CMC leadership for assigned commercial products... .../approval of IND/CTA/MAA/NDA/BLA submissions in a timely and efficient manner. Your Contributions... .... Provides strategic guidance on global regulatory CMC requirements to...Contract work$189k - $246k
...Travere Therapeutics is seeking a Director, Global Compensation to develop and oversee national and international compensation programs. The ideal candidate has over 10 years of relevant experience, particularly in the Pharmaceutical or Biotech sectors. Responsibilities...- ...What The Role Is The Manager, Regulatory Compliance, will assist in the management of the... ...focus on NERC 693 requirements and EIA submissions. If you don’t meet 100% of the qualifications... ...will make reasonable accommodations to enable individuals with disabilities to apply...H1bWork at officeVisa sponsorship
- ...standards. The ideal candidate will have a BA/BS in a relevant field and 3-4 years of leadership experience in customer service within a global medical device context. Strong communication skills and a commitment to customer service excellence are essential. #J-18808-Ljbffr...Remote work
$165k - $205k
...tandemdiabetes.comA DAY IN THE LIFE:The Director, Fulfillment & Inventory Planning, is responsible for leadership of logistics, global inventory management, clinical, S&OP for... ...including Privacy/HIPAA, and other legal and regulatory requirements.Maintains computerized...Long term contractLocal areaRemote workWork visaFlexible hours1 day per week- ...Contineum Therapeutics is seeking a Senior Director of Regulatory Affairs in San Diego, CA. This role leads regulatory activities for IND/CTA preparations and requires significant experience in the pharmaceutical/biotech industry. Candidates should have a Bachelor's degree...Remote work
$150k - $194k
...A biopharmaceutical company in San Diego seeks an Associate Director, Regulatory Affairs CMC. This role focuses on regulatory strategy execution for drug development. You will oversee regulatory submissions, maintain director-level interactions, and manage project timelines...Remote work$130k - $250k
...Director, Regulatory Affairs FULLY REMOTE Assignment through Temporary Agency - Approximately... ...in writing and crafting regulatory submissions ~ Demonstrated experience managing complex... ...with current industry standards and global regulations, and are effectively...Full timeTemporary workFor contractorsRemote work
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