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- ...Job Description About the Job The Regulatory Affairs Manager is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing the regulatory approval process (including US FDA and other regulatory...SuggestedFull time
- ...Reporting directly to the Executive Administrative Director (EAD) of the Moores Cancer Center Clinical Trials Office (CTO), the Manager, Regulatory Affairs leads a team of Regulatory Coordinators while taking on more programmatic responsibilities. With a focus on program...SuggestedHourly payFull timeWork at officeLocal areaRemote work
- ...and business risks; communicate legal and compliance issues to management and recommend appropriate mitigation strategies, utilizing... ...are aligned with corporate policies, business objectives, and regulatory requirements. Support contract negotiations and prepare summaries...SuggestedMinimum wageFull timeContract workWork at officeLocal area
- ...Manager/Director Regulatory Affairs - Pleasanton, CA In This Role, You Will Develop and implement regulatory strategies to obtain FDA clearances, approvals, and compliance for new and existing medical devices. Lead the preparation, submission, and maintenance of...SuggestedFull timeTemporary work
- ...Position: We are looking for an energetic and self-motivated Regulatory Affairs professional who will provide global regulatory expertise... ...(SSF), California, United States. The Regulatory Affairs Manager or Sr Manager will report to the Senior Director of Global Regulatory...SuggestedFull timeWork experience placementWork at officeWorldwide3 days per week
- Manager, Regulatory Affairs- Body ContouringCompany: AbbViePosition: Manager, Regulatory Affairs- Body ContouringLocation: Pleasanton, CAPosted: January 24, 2025Pleasanton, CAFull-timeSalary Min: 103500Salary Max: 197000Company DescriptionJob Description1. Submissions,...SuggestedTemporary workWork at officeLocal area
- ...Manager, Regulatory Affairs Advertising and Promotion Job Description At Gilead, were creating a healthier world for all people. For more than 35 years, weve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer working relentlessly to develop therapies...SuggestedFull timeFor contractorsLocal areaFlexible hours
- ...Operations Leadership team and will lead the Regulatory Compliance organization consisting of ~2... ...of Quality Operations as well as managing day-to-day activities of Regulatory Compliance... ..., quality control, or regulatory affairs function of veterinary or human pharmaceuticals...SuggestedCasual workDay shift
- Manager, Regulatory Affairs Advertising and Promotion Job Description At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies...SuggestedFull timePart timeFor contractorsLocal areaFlexible hours
- ...Manager, Regulatory Affairs-Document Coordinator Vir Biotechnology is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage...SuggestedFull timeContract workFor contractorsFor subcontractorWork at officeLocal areaVisa sponsorshipWork visaLive in
- ...Manager, Regulatory Affairs-Document Coordinator Join to apply for the Manager, Regulatory Affairs-Document Coordinator role at Vir Biotechnology, Inc. Manager, Regulatory Affairs-Document Coordinator 1 day ago Be among the first 25 applicants Join to apply...SuggestedFull timeContract workTemporary workWork at officeLocal areaWork visa
- ...Join our HR Control Management team today! This team maintains a strong and consistent control environment through... ...management support for internal audits and external regulatory exams supporting HR Regulatory Affairs Prepares committee materials on regulatory exams...SuggestedFull timeWork at officeFlexible hours
- ...Join our HR Control Management team today! This team maintains a strong and consistent control environment through... ...management support for internal audits and external regulatory exams supporting HR Regulatory Affairs Prepares committee materials on regulatory exams...SuggestedFull timeWork at officeFlexible hours
- Stryker is hiring an **Associate Manager, Regulatory Affairs** preferrable in **Portage, MI,** to join our **Craniomaxillofacial (CMF)** **Business!** In this role, you will lead and manage a team of regulatory professionals to ensure compliance with applicable regulatory...SuggestedTemporary workLocal areaRemote workFlexible hours
- ...Domain Assurance Manager, Functional Compliance, RCI Join to apply for the Domain Assurance... ...supporting organizations under regulatory settlements or consent decrees (e.g., Federal... ...-functional teams including Regulatory Affairs, Internal Audit, Legal, Privacy, Safety...SuggestedFull timeTemporary workFixed term contractWork at officeRemote work
- ...join us! Genmab is looking for an Associate Director, Global Regulatory Affairs, Regulatory Strategy to be a part of our Global Regulatory... ...strategy for the compounds. You must have strong project management capabilities and will be responsible for planning, coordinating...Full timeContract workFixed term contractWork at officeRemote work
- ...$200,000.00/yr Key Responsibilities: Define and deliver regulatory strategy for assigned programs, ensuring alignment with clinical... ...Sciences required; MS preferred ~812 years of regulatory affairs and pharmaceutical development experience ~ Strong experience...Full time
- ...Associate Director, Regulatory Affairs CMC - San Diego, CA Join to apply for the Associate Director, Regulatory Affairs CMC - San Diego, CA... ...collaboration with CMC and Quality colleagues. Initiate and/or manage relationships with external regulatory affairs CMC...Full time
- ...leads global strategies to maximize global regulatory success towards achievement of program... ...Ensures project team colleagues, line management, and key stakeholders are apprised of developments... ...broad concepts within regulatory affairs and implications across the organization...Minimum wageFull timeTemporary workLocal areaRemote work
- ...control (CMC) requirements. Provide CMC Regulatory expertise for commercial and development... ...Work closely with the PSC/CMC, Regulatory Affairs, and Quality Assurance departments, as... ...and templates, as necessary. Track and manage regulatory actions associated with post-...Full timeLocal areaFlexible hours
- ...oversee the development and execution of regulatory CMC development and registration... ...processes. As part of the Global Regulatory Affairs CMC team, you will report to the Senior... ...you will contribute: Plan, execute and manage regulatory submissions for assigned...Minimum wageFull timeTemporary workLocal areaRemote workWorldwideNight shift
- ...Associate Director, Regulatory Affairs, Advertising and Promotion Join to apply for the Associate Director, Regulatory Affairs, Advertising... ...enforcement which may impact the Companys promotional activities. Manage interaction with the Office of Prescription Drug Promotion...Full timeWork at officeLocal areaFlexible hoursNight shift
- ...Associate Director/Director of Regulatory Affairs Associate Director/Director of Regulatory Affairs 4 days ago Be among the first 25 applicants... ...type Full-time Job function Job function Project Management and Strategy/Planning Industries Pharmaceutical...Full time
- ...hearts. Who you are We are looking for a regulatory strategist who will advise on regulatory pathways, managing documentation and timelines, and supporting the... ...s Degree in life sciences, quality, regulatory affairs or a related area of study or 10+ years of biologic...Full timeTemporary workRemote workWorldwide
- ...Associate Director, Regulatory Affairs - Global Labeling page is loaded Associate Director, Regulatory Affairs - Global Labeling Apply... ...regulatory agencies. You will provide strategic input and management oversight of regulatory labeling activities for multiple products...Full time
- ...female executives, and scientists. The Opportunity This Associate Director Regulatory Affairs APAC will work on-site at our Alameda, CA, location in the Diabetes Division. As a manager, the function of an Associate Director Regulatory Affairs, APAC (Asia Pacific)...Full timeShift work
- ...Functions: Develop and Execute Global Regulatory Strategies: Formulate and lead global... ...business benefits and risks. Lead and Manage Global Submission Activities: Oversee submission... ...: ~11 years or more in Regulatory Affairs in biologic industry experience...Full timeLocal area
- ...assigned products to ensure compliance with regulatory requirements while meeting corporate... ...liaison with OPDP for assigned products and manages interactions including responses to... ...preferred. Minimum of 7 years of regulatory affairs experience., including at least 5 years...Full timeWork at officeLocal area
- ...Join to apply for the Associate Director, Regulatory Affairs role at Mirum Pharmaceuticals, Inc. Join to apply for the Associate Director... ...The Associate Director, Global Regulatory Affairs provides management of all aspects of assigned regulatory activities for the...Full timeOdd jobLocal areaRemote work2 days per week
- ...Associate Director Regulatory Affairs CMC Join to apply for the Associate Director Regulatory Affairs CMC role at Acadia Pharmaceuticals... ...Ability to work in a cross-functional team environment and manage competing priorities. Strong interpersonal skill, attention...Full timeWork at officeLocal areaRemote workWorldwideNight shift