Regulatory Compliance Specialist

About the RoleThe Director for U.S. Advertising and Promotion will provide strategic regulatory guidance to internal stakeholders on communications related to Alnylam's marketed products, investigational treatments, and disease areas. This role will enable achievement of business objectives while ensuring compliance with U.S. laws and regulations and Alnylam...

About the RoleThe Compliance Specialist at LexisNexis Risk Solutions FL Inc. Company is responsible for ensuring regulatory compliance across various jurisdictions in the United States. This role involves working closely with a manager to review and submit notice filings, as well as assisting with special filing projects such as initial filings, name...

Job Title: Senior Regulatory Affairs Specialist, OperationsAbout the Role:The Senior Regulatory Affairs Specialist will work within our Sleep & Respiratory Care business group (SRC) on home and hospital respiratory care products.This role will primarily support Software as a Medical Device (SaMD) and may include support for ventilators, oxygenators, and...

About the RoleWe are seeking a highly skilled and experienced Senior Manager to join our R&D Quality team. As a key member of our team, you will be responsible for leading the development and implementation of regulatory compliance strategies and ensuring that our R&D programs meet the highest standards of quality and regulatory compliance.Key...

LaBine and Associates is seeking a highly skilled Accounting Compliance Specialist to join our elite team in a hybrid role based in Cambridge, MA, or Reston, VA. This high-impact position ensures our business systems meet DFARS regulations and internal policies.Key Responsibilities:Compliance with DFARS, FAR, and internal policies.Cost accounting for...

Job Title: Director/Senior Director, Regulatory AffairsAbout the Role:Lifelancer is seeking a seasoned Regulatory Affairs professional to join our team as a Director/Senior Director, Regulatory Affairs. In this critical role, you will be responsible for developing and implementing global regulatory strategies for our development programs, ensuring compliance...

Company Overview:Beam Therapeutics is a pioneering biotechnology company dedicated to developing innovative genetic medicines. Our mission is to revolutionize the treatment of serious diseases by harnessing the power of precision genetic editing.We are committed to a values-driven approach, prioritizing cutting-edge science, and a vision of providing...

The OpportunityWe are seeking a seasoned regulatory affairs professional to join our growing team at Relay Therapeutics. As a strategic regulatory leader, you will play a critical role in defining and implementing innovative regulatory strategies to accelerate the development and approval of our transformative pipeline.You will serve as the global regulatory...

Biogen is seeking a talented student to join its Internal Audit department for a 6-month co op role. As an IT Auditor and Compliance Specialist, you will assist the Company in assessing the reliability of financial information and IT systems. The ideal candidate will have a strong understanding of IT, audit, and business operations principles.The successful...

Job SummaryWe are seeking a highly skilled Regulatory Advisor to join our team at Takeda. As a key member of our regulatory team, you will be responsible for developing and implementing innovative regulatory strategies for drug-device combinations in the US market.Key ResponsibilitiesDevelop and implement regulatory strategies for drug-device combinations in...

Regulatory Labeling DirectorWe are seeking a highly skilled Regulatory Labeling Director to join our team at BioSpace, Inc. This is a unique opportunity to leverage your expertise in regulatory labeling to drive the success of our respiratory franchise products.Key Responsibilities:Develop and maintain current knowledge of labeling regulations and industry...

Job DetailsThe Role:As a key member of our Global Regulatory Science team, we are seeking a Director of Global Regulatory Strategy to develop and lead the global strategy for our mRNA vaccine programs. The ideal candidate will have a strong background in regulatory strategy, particularly in vaccine development, and will be able to articulate clear and...

Job Title: Government Accounting SpecialistLocation: Hybrid - Cambridge MA/Reston VAWe are seeking a skilled Government Accounting Specialist for a hybrid role based in Cambridge, MA, or Reston, VA. This high-impact position ensures our business systems meet DFARS regulations and internal policies. You will be integral to cost accounting compliance for...

Job SummaryThe Senior Director, US Commercial Regulatory Affairs will lead the development and implementation of regulatory strategies to support Ipsen's commercial operations in the US. This role will be responsible for ensuring compliance with FDA regulations and guidelines, as well as maintaining strong relationships with key stakeholders.Key...

About the RoleWe are seeking a highly skilled Senior Director, Global Regulatory Lead, GI to join our team at Takeda. As a key member of our organization, you will be responsible for defining, developing, and leading global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects.Key...

Job SummaryThe Regulatory Operations Senior Publishing Specialist is responsible for planning, creating, and submitting regulatory submissions. In collaboration with the Regulatory Lead, you will plan and prepare high-quality global submissions, in-house or via CRO, ensuring delivery of compliant submissions to global health authorities in a timely manner....

Job Title: Government Accounting and Compliance SpecialistLocation: Hybrid - Cambridge MA/Reston VAWe are seeking a skilled Government Accounting and Compliance Specialist to join our team at LaBine and Associates. This high-impact role ensures our business systems meet DFARS regulations and internal policies.Key Responsibilities:Ensure compliance with...

Job SummaryWe are seeking a highly skilled and dedicated individual to join our team as a Title IX Compliance Specialist. This dynamic role offers the opportunity to support the HMS and Harvard-wide communities, implement impactful initiatives, and ensure adherence to crucial policies related to Title IX, Non-Discrimination, and Anti-Bullying.Key...

Job Title: Regulatory Affairs Business AnalystWe are seeking a highly skilled Regulatory Affairs Business Analyst to join our team in Cambridge, MA.About the Role:This is a Heavy Data Migration role, requiring knowledge of Regulatory, Publishing, or EDMS models. The ideal candidate will have strong interpersonal and teamwork skills, with the ability to...

Job Title: CSV SpecialistJob Summary:We are seeking a highly skilled CSV Specialist to join our team at LS Solutions. The ideal candidate will have a strong background in CSV management, integration, and compliance.Key Responsibilities:Manage end-to-end CSV deliverables for new and existing applications.Draft and review documents for CSV deliverables,...