Regulatory Assistant
2 weeks ago
Regulatory AssistantOur client needs a Regulatory Assistant to support the Regulatory Specialist, as their confections and chocolate products are in high demand As the regulatory assistant, you will prepare labels, product claims, finished product specifications, certification submissions, and export documentation.Essential Functions and Responsibilities:Handle multiple label packaging projects and execute regulatory responsibilities at a high degreeUpdate nutritional database and corresponding ingredient specification information with provided softwareProof packaging artwork for accurate information at each stage in the design process including graphics review, printing, productionClarify necessary revisions with global suppliers and follow up through effective communicationConduct finished product packaging audits against ingredient specificationsRemain updated on information of current US labeling and food product regulationsMaintain a system/database of final packaging and/or labels to include supporting documentation needed for complianceDevelopment and review of specifications for company productsReview specifications, packaging, and labeling proofs to ensure accuracy and regulatory complianceReview supplier nutrition and composition information to evaluate for completeness and regulatory complianceEnsure all Food Safety and regulatory compliance is met regarding labels and specificationsTechnical Qualifications:Bachelor s degree preferredKnowledge of USDA and FDA labeling regulations, Canada, EU a plusWill consider industry experience1-2 years in food industry with experience in regulatoryOrganized and detail oriented, proof reading and time managementProficiency in R&D software like Recipal, Genesis and MS OfficeAbility to work cross-functionally with team members on multiple projects**If you d like to hear more about this opportunity and others we are currently working on, please contact Damon Wickmann at dwickmann cps4jobs.com.JO: 111.24DW#LI-DM2
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Data Engineer
2 weeks ago
Boston, United States OneSource Regulatory Full timeCompany Introduction OneSource Regulatory Technology hosts a number of innovative solutions to enhance job performance in the Pharmaceutical space. OSR Technology is looking for an experienced and dedicated data engineer to join our product solutions team! Job Description OneSource Regulatory is trying to identify a full-time contractor with at least 4+...
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Data Engineer
4 weeks ago
Boston, United States OneSource Regulatory Full timeJob DescriptionJob DescriptionSalary: Company IntroductionOneSource Regulatory Technology hosts a number of innovative solutions to enhance job performance in the Pharmaceutical space. OSR Technology is looking for an experienced and dedicated data engineer to join our product solutions team! Job DescriptionOneSource Regulatory is trying to identify a...
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Boston, MA, United States State Street Corporation Full timeWho we are looking for The Regulatory Analyst and Scheduling Manager is responsible for coordinating and managing the scheduling of interactions and associated meetings. across multiple regulatory authorities in accordance with the Global Regulatory Liaison Office Engagement Program . This role will also provide primary executive management support to Global...
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Regulatory Affairs Associate
2 weeks ago
Boston, United States INTELLECTT INC Full timeRole: Regulatory Affairs Associate Location: Remote Duration: 7 Months Main Responsibilities Provide regulatory input to product lifecycle planning. Assist in SOP development and review. Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes. Understand and investigate regulatory history/background of...
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Hybrid Regulatory Intern
4 weeks ago
Boston, United States Withings Full timeThe Regulatory Affairs Intern will support the Regulatory Affairs team in daily tasks, projects, and FDA submission activities including: Assist in drafting, organizing, and editing regulatory documents for 510(k) submissions. Coordinate workflow for regulatory document reviews (internal and external) within submission timelines. Coordinate with...
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Hybrid Regulatory Intern
4 weeks ago
Boston, United States Withings Full timeJob DescriptionJob DescriptionThe Regulatory Affairs Intern will support the Regulatory Affairs team in daily tasks, projects, and FDA submission activities including:Assist in drafting, organizing, and editing regulatory documents for510(k) submissions.Coordinate workflow for regulatory document reviews (internal andexternal) within submission...
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Principal Regulatory Specialist
4 days ago
Boston, United States Amplitude Vascular Systems Full timeDuties and Responsibilities: Works with R&D and Operations to establish regulatory requirements at all phases of product/process development and manufacturing. Works with R&D on product V&V activities including sterilization, packaging/labeling, transit testing, real time/accelerated aging as well as review and approval of engineering protocols and reports....
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Principal Regulatory Specialist
2 days ago
Boston, United States Amplitude Vascular Systems Full timeDuties and Responsibilities:Works with R&D and Operations to establish regulatory requirements at all phases of product/process development and manufacturing.Works with R&D on product V&V activities including sterilization, packaging/labeling, transit testing, real time/accelerated aging as well as review and approval of engineering protocols and...
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Principal Regulatory Specialist
6 days ago
Boston, United States Amplitude Vascular Systems Full timeDuties and Responsibilities:Works with R&D and Operations to establish regulatory requirements at all phases of product/process development and manufacturing.Works with R&D on product V&V activities including sterilization, packaging/labeling, transit testing, real time/accelerated aging as well as review and approval of engineering protocols and...
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VP of Regulatory Affairs
3 weeks ago
Boston, United States Compass Therapeutics Full timeJob DescriptionJob DescriptionCompass Therapeutics, Inc. is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. Compass' scientific focus is on the relationship between angiogenesis, the immune system and tumor growth. Our pipeline of novel product candidates is...
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VP of Regulatory Affairs
2 weeks ago
Boston, United States Compass Therapeutics Full timeJob DescriptionJob DescriptionCompass Therapeutics, Inc. is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. Compass' scientific focus is on the relationship between angiogenesis, the immune system and tumor growth. Our pipeline of novel product candidates is...
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Sr. Manager Regulatory
2 weeks ago
Boston, United States Scientific Search Full timeSr. Manager Regulatory Affairs - CMC Location: Remote Industry: Biopharma Contract: 1 year contract Our California based biopharmaceutical client working in the rare disease space with one approved product and others behind it has tasked our team in finding them a Regulatory Affairs Consultant for a 1 year contract assignment. Working with the product leads,...
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Principal Regulatory Affairs Specialist
4 days ago
Boston, United States BRIOHEALTH SOLUTIONS INC Full timeJob DescriptionJob DescriptionPrincipal Regulatory Affairs SpecialistJob DescriptionBrioHealth Solutions Inc., Inc. is seeking a skilled and self-motivated Principal Regulatory Affairs Specialist to join our growing team. As a principal regulatory affairs specialist at BrioHealth Solutions Inc., you’ll support product development activities for Class III...
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Hybrid Regulatory Intern
4 weeks ago
Boston, Massachusetts, United States Withings Full timeThe Regulatory Affairs Intern will support the Regulatory Affairs team in daily tasks, projects, and FDA submission activities including: Assist in drafting, organizing, and editing regulatory documents for 510(k) submissions. Coordinate workflow for regulatory document reviews (internal and external) within submission timelines. Coordinate with...
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Accreditation and Regulatory Specialist
2 weeks ago
Boston, United States Boston Medical Center Full timePOSITION SUMMARY: Under the direction of the Senior Director, Accreditation & Regulatory and working collaboratively, the Accreditation and Regulatory Specialist (Nurse) leads efforts to ensure continual organizational compliance and ongoing readiness with clinical quality and patient safety standards and regulations required by The Joint Commission,...
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AVP, Regulatory Capital
4 weeks ago
Boston, United States Global Atlantic Financial Group Full timeThe Assistant Vice President (AVP) will be responsible for asset-related, Bermuda regulatory capital reporting for our multiple reinsurers, coordinating accounting, and investment support in a larger matrix organization. The Assistant Vice President will evaluate new investments for capital impact, represent us in development of new reporting, controls, and...
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Director, Regulatory Affairs
5 days ago
Boston, United States Imbria Pharmaceuticals Full timeCompany Overview Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cells ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor to...
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Director, Regulatory Affairs
2 weeks ago
Boston, United States Imbria Pharmaceuticals Full timeCompany OverviewImbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell’s ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor to...
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Interim Regulatory Reporting Consultant
2 days ago
Chicago, IL, United States Brilliant Staffing LLC Full timeOur client is looking for a Regulatory Reporting Consultant to assist in the preparation and filing of regulatory financial fillings.Regulatory Reporting Consultant Responsibilities:Assist in the preparation and filing of regulatory financial filings.Complete and submit regulatory reporting filings ensuring compliance with rules and regulations established...
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Research Assistant II BWH Neurology
2 days ago
Boston, MA, United States Partners Healthcare System Full timeHarvard Aging Brain Study investigators at Brigham and Women's Hospital and Massachusetts General Hospital are looking for a Research Assistant to coordinate the development and implementation of a novel, smart-phone based cognitive test: the Boston Remote Assessment of NeuroCognitive Health (BRANCH), created by Drs. Kathryn Papp and Rebecca Amariglio. This...