NewSenior Manager, Regulatory Affairs CMC Fate Therapeutics, Inc.Senior Manager, Regulatory Affairs CMCSan Diego, CA$160,000–$190,000 / yearThe Company’s pipeline includes iPSC-derived T-cell and natural killer (NK) cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. The ideal candidate is a collaborative regulatory professional with strong CMC expertise, biotechnology or pharmaceutical experience, sound judgment, and the communication skills to influence cross-functional teams in a fast-paced, mission-driven environment.
Manager, Regulatory Affairs Adicet BioManager, Regulatory AffairsRedwood City, California$130,000–$179,000 / yearAdicet is located in a state-of-the-art facility and works to create an incredible office experience with an onsite gym and various other fitness options, onsite parking with electric vehicle charging stations and free shuttle (Caltrain), company-subsidized lunches (delivered onsite daily) and fully stocked breakrooms. They will be primarily responsible for managing the global CMC regulatory implementation of assigned projects in early to late-stage development, with additional responsibility to support the implementation of other regulatory activities, including clinical and nonclinical submissions.
Project Manager, Regulatory Affairs (Clinical and CMC) Mitchell MartinProject Manager, Regulatory Affairs (Clinical and CMC)Encinitas, CARemote$49–$70 / hourBy applying for this job, you agree to receive AI-generated calls, text messages, and/or emails from Mitchell Martin Inc and its affiliates and contracted partners at various frequency through traditional and automated methods. This is a remote contract position focused on managing regulatory affairs projects related to clinical and CMC processes.
Manager, Regulatory Affairs Adicet Bio IncManager, Regulatory AffairsRedwood City, CA$130,000–$179,000 / yearAdicet is located in a state-of-the-art facility and works to create an incredible office experience with an onsite gym and various other fitness options, onsite parking with electric vehicle charging stations and free shuttle (Caltrain), company-subsidized lunches (delivered onsite daily) and fully stocked breakrooms. They will be primarily responsible for managing the global CMC regulatory implementation of assigned projects in early to late-stage development, with additional responsibility to support the implementation of other regulatory activities, including clinical and nonclinical submissions.
NewSenior Manager, Regulatory Affairs StrykerSenior Manager, Regulatory AffairsIrvine, CaliforniaHowever, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. The Senior Manager leads regulatory operations, regulatory submissions and compliance activities, provides expert guidance on product changes and labeling, and develops a high-performing Regulatory Affairs team.
Senior Regulatory Affairs Specialist - Manager Synaptic Medical LLCSenior Regulatory Affairs Specialist - ManagerCarlsbad, CAKey responsibilities: Lead the regulatory strategy for new product development and market entry, including 510(k), PMA, and CE Mark submissions. What we are looking for: Bachelor's degree in a scientific, engineering, or related field (RAC certification or advanced degree a plus).
Senior Manager, Global Regulatory Affairs, CMC Jazz Pharmaceuticals PlcSenior Manager, Global Regulatory Affairs, CMCCARemote$140,000–$210,000 / yearThe successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. Participate and support as an active member of a multi-disciplinary team to establish Regulatory CMC strategies for commercial products, late- and early-stage development programs, under the supervision of GRA-CMC leadership.
Manager, Regulatory Affairs iRhythm TechnologiesManager, Regulatory AffairsSan Francisco, CARemote$127,000–$165,000 / yearLead FDA submissions (510(k) or pre-submissions) with the team, including wearable devices, as well as artificial intelligence (AI) Software as a Medical Device (SaMD) products. There have been instances where individuals not associated with iRhythm have impersonated iRhythm employees pretending to be involved in the iRhythm recruiting process, or created postings for positions that do not exist.
Senior Manager, Government & Regulatory Affairs Geico InsuranceSenior Manager, Government & Regulatory AffairsSacramento, CA$158,875–$248,050 / yearWhat You'll Do: Policymaker Engagement: Build and maintain a strong network of key policymakers, including state legislators, heads of relevant executive agencies and their staff, industry members, policymakers (NAIC and NCOIL), and trade associations to efficiently and effectively advocate GEICO's positions in assigned states. Strategic Monitoring & Reporting: Proactively identify evolving regulatory and legislative trends and effectively communicate relevant insights and potential risks to the Government & Regulatory Affairs team, business units, and senior management to support informed, enterprise-wide strategic decision-making.
Senior Manager Regulatory Affairs US Advertising and Promotion - Immunology - Hybrid AbbVie IncSenior Manager Regulatory Affairs US Advertising and Promotion - Immunology - HybridIrvine, CAApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
Manager I, Regulatory Affairs Operations Tarsus PharmaceuticalsManager I, Regulatory Affairs OperationsIrvine, CaliforniaRemote$97,500–$136,500 / yearThe Manager I, Regulatory Affairs Operations will report to the Director, Regulatory Affairs Operations, and will primarily assist in managing Electronic Document Management System (Veeva Vault RIM) and regulatory submissions activities. Under the guidance of the Director, knowledgeable resource for regulatory advice in developing submission content plans, with hands-on responsibility for regulatory document management.
Manager I, Regulatory Affairs Operations Tarsus Pharmaceuticals IncManager I, Regulatory Affairs OperationsIrvine, CARemote$97,500–$136,500 / yearThe Manager I, Regulatory Affairs Operations will report to the Director, Regulatory Affairs Operations, and will primarily assist in managing Electronic Document Management System (Veeva Vault RIM) and regulatory submissions activities. Under the guidance of the Director, knowledgeable resource for regulatory advice in developing submission content plans, with hands-on responsibility for regulatory document management.
Manager, Regulatory Affairs iRhythmManager, Regulatory AffairsSan Francisco, CaliforniaRemote$127,000–$165,000 / yearLead FDA submissions (510(k) or pre-submissions) with the team, including wearable devices, as well as artificial intelligence (AI) Software as a Medical Device (SaMD) products. There have been instances where individuals not associated with iRhythm have impersonated iRhythm employees pretending to be involved in the iRhythm recruiting process, or created postings for positions that do not exist.
NewSenior Manager, Regulatory Affairs CMC Fate Therapeutics IncSenior Manager, Regulatory Affairs CMCSan Diego, CA$160,000–$190,000 / yearThe Company's pipeline includes iPSC-derived T-cell and natural killer (NK) cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. The ideal candidate is a collaborative regulatory professional with strong CMC expertise, biotechnology or pharmaceutical experience, sound judgment, and the communication skills to influence cross-functional teams in a fast-paced, mission-driven environment.
(Senior) Manager, Regulatory Affairs Braveheart Bio(Senior) Manager, Regulatory AffairsSan Francisco, California$119,000–$190,000 / yearOur lead product candidate, BHB-1893, is a next-generation oral small-molecule cardiac myosin inhibitor (CMI) being developed for the treatment of obstructive HCM (oHCM) and non-obstructive HCM (nHCM). Reporting into the Vice President of Regulatory Affairs, this individual will manage the CRO(s) responsible for preparing CTAs, as well as coordinate preparation of cross‑functional deliverables and manage health authority queries and responses.
Associate Director, Project Manager - Regulatory Affairs Travere Therapeutics IncAssociate Director, Project Manager - Regulatory AffairsSan Diego, CARemote$150,000–$195,000 / yearThis role supports regulatory submissions for investigational and commercial rare disease therapies, facilitates cross-functional collaboration and manages timelines to achieve company objectives in a fast-paced, patient-focused environment. Create and maintain regulatory dashboards, milestone trackers, and status reports to provide visibility to Regulatory Affairs leadership, program teams, and senior management on progress, risks, issues, and upcoming deliverables.
Senior Manager, Government & Regulatory Affairs GEICO GENERAL INSURANCE COMPANYSenior Manager, Government & Regulatory AffairsSacramento, CA$158,875–$248,050 / yearWhat You'll Do: Policymaker Engagement: Build and maintain a strong network of key policymakers, including state legislators, heads of relevant executive agencies and their staff, industry members, policymakers (NAIC and NCOIL), and trade associations to efficiently and effectively advocate GEICO's positions in assigned states. Strategic Monitoring & Reporting: Proactively identify evolving regulatory and legislative trends and effectively communicate relevant insights and potential risks to the Government & Regulatory Affairs team, business units, and senior management to support informed, enterprise-wide strategic decision-making.
Senior Manager, CMC Regulatory Affairs - Small Molecules Travere Therapeutics IncSenior Manager, CMC Regulatory Affairs - Small MoleculesSan Diego, CARemote$132,000–$172,000 / yearThe Senior Manager serves as the primary CMC Regulatory Affairs representative on cross-functional teams and partners closely with Pharmaceutical Development, Technical Operations, Manufacturing, Quality, Analytical Development, Supply Chain, Regulatory Operations, and Project Management to ensure alignment of CMC development plans with regulatory requirements and business objectives. This position requires extensive experience supporting small molecule drug product development from IND through commercialization, with significant expertise in oral solid dosage forms, drug product manufacturing, formulation development, analytical methods, process validation, and lifecycle management.
Regulatory Affairs Manager - Heart Failure (on-site) Abbott LaboratoriesRegulatory Affairs Manager - Heart Failure (on-site)Pleasanton, CA$114,000–$228,000 / yearAs an individual contributor, the function of a Regulatory Affairs Manager is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.
Manager, Regulatory Affairs Arrowhead PharmaceuticalsManager, Regulatory AffairsLos Angeles, CA$145,000–$160,000 / yearArrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes.