- Merck & Co. (Upper Gwynedd, PA)
- …Application (BLA), Electronic Common Technical Document (eCTD), Immunochemistry, International Regulatory Compliance, Microbiology, Molecular Microbiology, ... Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance… more
- Eisai, Inc (Nutley, NJ)
- …Substantial experience in inspection management. Substantial experience with US, EU, and international regulatory standards and guidelines for the conduct of ... clinical trials. Demonstrated ability to operate and influence decision-making processes Effective communication skills Successful track record of supervising employees and managing cross-cultural differences Technical and administrative capabilities to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory ... Process Excellence & Analytics function, responsible for ensuring Daiichi Sankyo's Regulatory processes & procedural documentation are fit for purpose and compliant… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards. ... while ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This role… more
- CryoLife (Kennesaw, GA)
- …as needed. Work with cross-functional teams and subject matter experts to maintain regulatory compliance. Team with international regulatory colleagues to ... experts to maintain regulatory compliance and address inquiries from international regulatory agencies. Align with RA leadership on the reviews needed for… more
- Cedent (Brecksville, OH)
- …of European, ISO 13485 and FDA regulations preferred. Knowledge of international regulatory guidelines regarding GMP requirements is desirable. ... with FDA, ISO, European, Canadian, and other standards. Work with the international department on various regulatory filings for product registration in… more
- Michael Page (Skokie, IL)
- …a plus). Additional certifications or training in FDA regulations, GMP, HACCP, or international regulatory standards (eg, ISO, NSF, FSSC) are highly desirable. ... innovation, and integrity. Renowned for their steadfast commitment to quality, regulatory compliance, and consumer trust, they create cutting-edge products that not… more
- Katalyst HealthCares and Life Sciences (Matthews, NC)
- Responsibilities: Preparing documentation for international regulatory registrations. Preparing technical documentation to compliant to MDD and EU MDR. Defining ... worldwide regulatory requirements are necessary for regulatory approval...the medical device industry. FDA, EU, Health Canada, and international registrations experience. Working knowledge with quality system regulations… more
- Genmab (NJ)
- …methodologies that may support innovation and improve efficienciesEngage with regulatory authorities on compound/indication level discussionsActs as a role ... analyses requiring advanced statistical methodologies/techniquesRepresent the CDT/the company at regulatory meetings, during Key Opinion Leaders meetings, network and/or… more
- RES Consultant Group (Irvine, CA)
- …: Mentor and develop junior staff, providing guidance and technical training on international tax matters. Regulatory Updates : Stay updated on changes in ... Nationally ranked CPA firm is hiring an International Tax Manager who will be responsible for...Tax Manager who will be responsible for overseeing the international tax compliance and advisory services for a variety… more
- Merck & Co. (Rahway, NJ)
- …regulatory reporting, publication, and presentation at national and international meeting.- He/she will provide internal scientific leadership for ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing… more
- Insmed Incorporated (San Diego, CA)
- …of Clinical Quality Assurance (CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs, acts as quality lead on the gene therapy ... all systems, processes and their outcomes comply with applicable international and national standards, regulations and guidelines.ResponsibilitiesResponsibilities (Essential Role… more
- Genmab (NJ)
- …a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading ... portfolio of products. The lead may also be responsible for supporting various regulatory policy and/or intelligence deliverables. This role will be within Global … more
- Merck & Co. (Omaha, NE)
- …and will work closely with freight forwarders, QA departments, USDA and other regulatory officers. Provide data to the Finance department so they can assign transfer ... ResponsibilitiesExport Order ProcessingCommunicate with Animal Health and our Company International Affiliates and Third-Party Customers to schedule shipments and… more
- Prospect International Airport Services (Cleveland, OH)
- …Prospect Wheelchair Supervisor - CLE Date Wednesday, July 16, 2025 Entity Prospect International Airport Services State Ohio City Cleveland Base Pay Rate: $ 18.00 ... functions. Monitors and enforces safe working conditions in accordance with regulatory requirements, Unifi policies and safety procedures, and all applicable laws.… more
- Prospect International Airport Services (Chicago, IL)
- …of Operations - ORD Date Wednesday, July 2, 2025 Entity Prospect International Airport Services Posting City Chicago Posting State Illinois Exempt or Non-Exempt ... manner. Monitors and enforces safe working conditions in accordance with regulatory requirements, Unifi policies and safety procedures, and all applicable laws.… more
- Prospect International Airport Services (Baltimore, MD)
- …Prospect Wheelchair Lead - BWI Date Saturday, June 21, 2025 Entity Prospect International Airport Services State Maryland City Baltimore Base Pay Rate: $ 17.00 ... for usage. Monitors and enforces safe working conditions in accordance with regulatory requirements, Unifi policies and safety procedures, and all applicable laws.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
