Hybrid Regulatory Affairs Specialist - Submissions
Anika Corporation
Anika is seeking a Regulatory Affairs Specialist II to support regulatory submissions, authority interactions, and post-approval activities. The role requires preparing documentation, maintaining compliance, and guiding cross-functional teams through regulatory processes. The position emphasizes attention to detail, strong organizational skills, and the ability to manage multiple priorities in a fast-paced environment, with hybrid work based in Bedford, MA. #J-18808-Ljbffr Anika Corporation
- Glaukos Corporation in Acton, MA, is seeking a Sr. Regulatory Affairs Specialist to lead the preparation of regulatory submissions for the U.S. and international markets. The role is hybrid and full-time, requiring a proactive regulatory mindset and collaboration with...SuggestedFull time
- Anika-GCC in Bedford, MA is seeking a Regulatory Affairs Specialist II to support regulatory submissions and regulatory authority interactions related to product submissions and approvals. You will prepare and submit regulatory documentation, support product market approval...Suggested
$66k - $82k
What You'll Do The Regulatory Affairs Specialist II supports regulatory submissions and regulatory authority interactions related to product submissions and approvals... ...benefits at any time, subject to applicable law. Hybrid position based in Bedford, MA Location Bedford,...SuggestedFull timeImmediate start- Sr. Regulatory Affairs Specialist role at Glaukos Corporation Sr. Regulatory Affairs Specialist (Hybrid - Acton, MA) The Sr. RA Specialist is Responsible for preparation of regulatory submissions (domestic and foreign). Ensure implementation and maintenance of regulatory...SuggestedFull time
- The Sr. RA Specialist is Responsible for preparation of regulatory submissions (domestic and foreign). Ensure implementation and maintenance of regulatory filing in... ...regulatory agenciesAssist with other basic Regulatory Affairs functions, such as scanning and archiving...SuggestedLocal area
- ...partnering with sponsors and investigators to ensure compliant, timely submissions. The role emphasizes leadership, process improvement, and expertise in sponsored research regulations, with a hybrid work setup and emphasis on collaboration across #J-18808-Ljbffr...Work at office
- ...with the US regulation. Plan and prepare submissions for US Class II devices, including... ...and compiling documents for submission to regulatory authorities, as well as assisting in responding... ...with ability to work independently in hybrid/in-person setting (Bedford, MA). ~...Worldwide
$77.5k - $105.1k
...Office of the Vice President for Research to oversee ethical and regulatory reviews for human subjects research. The role requires a... ...skills, and familiarity with FDA regulations. It is a full-time hybrid position with a pay range of $77,500-$105,100. #J-18808-Ljbffr...Full timeWork at office- ...of Global Labeling to provide strategic regulatory expertise for drug labeling. This role involves... ...Advanced degree. The position offers a hybrid work model, requiring onsite presence 3... ...MA. A strong track record in regulatory affairs and excellent communication skills are...3 days per week
- ...Senior Regulatory Affairs Specialist BrioHealth Solutions is seeking a skilled and self-motivated Senior Regulatory Affairs Specialist to support... ..., US and EU clinical studies and regulatory planning and submission activities. What You'll Do Prepare, review, and...
- ...Associate Director of Regulatory Affairs CMC Hybrid Role The Associate Director of Regulatory Affairs CMC will support development CMC team activities... .... This position will oversee CMC Health Authority submissions, collaborating across the business and with external...
- ...Switzerland GmbH in Cambridge, MA is seeking an Associate Director, Regulatory Affairs CMC to lead the development and execution of global... ...experience and proven regulatory leadership. The position allows for hybrid work arrangements, reflective of Alnylam's commitment to...
- PharmaEssentia USA is seeking a Healthcare Compliance Manager for a hybrid role based in Burlington, MA, with up to 15% travel. You will partner with Sales, Marketing, Medical Affairs, and other teams to implement and strengthen the company’s compliance program under US...
- Position Overview This position is intended to provide Regulatory Affairs support to FUJIFILM Healthcare Americas Corporation. This position... ..., listing, licensing, notification and approval information submission to regulatory authorities or authorized representative...Local areaRemote workFlexible hours
- ...background to underwrite and manage a loan portfolio. You will support Lending Officers and report to the Commercial Credit Officer in a hybrid work setting. Responsibilities include credit evaluation, adherence to LUAG and Credit Policy, risk management, covenant monitoring...
- ...provide budgeting/financial flexibility by offering contingent labor as a variable cost.Job Description• The Regulatory Affairs Operations (RA Ops) submission group is organized to provide submission development support to project teams and the regulatory community. The...Immediate start
- ...Power is seeking an experienced Office and Events Coordinator to support the executive team from our Burlington, MA location in a hybrid setup. The role includes calendar management, meeting coordination, and facilitating office operations for the corporate office. The...Work at office
- ...seeking a Healthcare Compliance Manager in Burlington, MA. This hybrid role (up to 3 days in office) supports the U.S. Legal and... ...training, and collaboration with global stakeholders to ensure regulatory alignment and program effectiveness. #J-18808-Ljbffr PharmaEssentia...Work at office
- ...staffing company is seeking a skilled professional to join their Regulatory Affairs Operations team. The candidate will be responsible for... ...standards. Ideal candidates will have at least four years of submission publishing experience and a relevant bachelor's degree. This...
$88.8k - $184.46k
...retirement funding and healthcare financing, risk management and regulatory compliance, data analytics and business transformation.Milliman... ...working tools such as Access and PowerPointLocationThis is a hybrid position for candidates with under five years of relevant full-...Full timeTemporary workWork experience placementWork at officeLocal areaRemote workWorldwideFlexible hours$86.8k - $165.2k
...TUCSON-848 ~ 1151 E Hermans Rd ~ BLDG 848 Position Role Type:Hybrid U.S. Citizen, U.S. Person, or Immigration Status Requirements... ...coordinate a cross functional team regarding contractual EVMS submissions, develop, present and defend monthly Latest Revised Estimates...Contract workTemporary workWork experience placementWork at officeRemote workRelocation packageFlexible hours$250k
...Burlington, MA client. This is the #1 role in accounting, overseeing all accounting operations and reporting to the CFO. The position is hybrid in-office (Mon-Thu). Candidates must have a CPA (active/inactive), 10+ years in product manufacturing or CPG, progressive...Work at office- ...Coordinator, Medical Education to support residency programs at Lahey Clinic. The role is on-site for at least three months with a hybrid option after training. You will coordinate residency activities, ensure ACGME compliance, manage databases (ERAS, New Innovations),...
- MilliporeSigma in the United States is seeking an Associate Manager Regulatory CMC to support all CMC regulatory activities, own the CMC... ...strategy, and lead dossier content decisions for worldwide submissions. Hybrid work in Billerica, MA, with responsibilities spanning...Worldwide
- ...MA. The role supports AFLCMC/ES in modernizing and sustaining ESS portfolio software and hardware. The position is full-time with a Hybrid work model requiring 2 days on-site weekly. Responsibilities include budgeting, forecasting, EVM, and delivering financial...Full time
$134.2k - $202.2k
...organization.Your Role:The Senior Manager Regulatory CMC (RCMC) is responsible and... ...making on content, for assigned submissions worldwide, and serves as the Regulatory Affairs CMC contact point and acts as... ...Regulatory CMC topics.Location: Hybrid (3x/week) in Billerica, MA...Local areaImmediate startWorldwide$36.7k - $61.3k
...Compliance SpecialistThe Compliance Specialist is responsible for submitting notice filings... ...onsite in Medford, MA five days per week. Hybrid (one day) may be approved after... ...changes from client and preparation and submission of all files and related documents to state...Permanent employmentWork at officeLocal area- ...management, and compliance with all applicable regulatory, funder, and university requirements.... ...within grant applications prior to submission to sponsor for risk of foreign influence... ...Harvard-designated location, employees in hybrid positions must work in a Harvard...Work at office
$101.6k - $131.9k
...Job Summary Responsible for supporting regulatory activities regarding released product, including, MDR investigations submissions, post market risk assessments (HHA), supports... ...A minimum of 4 years of direct Regulatory Affairs experience is required, including...Shift work$94k - $150k
Job TitleSenior Regulatory Affairs SpecialistJob DescriptionSenior Regulatory Affairs Specialist, UltrasoundThe Senior Regulatory Affairs Specialist for Ultrasound collaborates... ...coordinating and preparing regulatory submission documents for agencies such as the FDA,...Full timeWork at officeImmediate startWork visaRelocation package3 days per week
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