- 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
- Katalyst HealthCares and Life Sciences (Boston, MA)
- Responsibilities: The role requires strong US, EU, China, and international regulatory experience that can be leveraged to help support international ... well as single-use disposables. Prior experience with 510(k) submissions, EU MDR and international regulatory registrations. Working knowledge of FDA, EU and … more
- Boston Scientific (Irvine, CA)
- …as developing regulatory strategies. The role requires strong US, EU, and international regulatory experience that can be leveraged to help support ... Regulatory colleagues on various projects, including providing support with international regulatory filings *Supports highly technical or major business… more
- Republic Services (Detroit, MI)
- …organizational and communication skills. Working knowledge of US, Canadian or international regulatory guidelines. MINIMUM QUALIFICATIONS: 2 years of experience ... POSITION SUMMARY: The Regulatory Coordinator provides administrative support with regulatory...The Regulatory Coordinator provides administrative support with regulatory compliance matters including but not limited to maintaining… more
- Calyxo (Pleasanton, CA)
- …respond to regulatory authorities. Your knowledge of domestic and international regulatory requirements will help guide internal stakeholders and contribute ... to Quality System processes. Must be familiar with US and international regulatory requirements for medical devices (eg, European medical device directives, … more
- Pall (Miami, FL)
- …System which makes everything possible.Director Global Quality and Regulatory ComplianceJOB SUMMARYInterprets federal/state/ international regulations as they ... an effective Industrial QMS that provides compliance to relevant international standards, customer requirements and regulatory requirements.Maintains oversight… more
- The ERM International Group Limited (Cleveland, OH)
- …site investigation/remediation projects under a variety of state, federal, and international regulatory structures (eg, CERCLA). Proven client and business ... manage multiple competing tasks and prioritize effectively. Advanced knowledge of the local regulatory climate in NY or PA a plus. Strong commitment to safety,… 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
- 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
- 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
- Genmab (NJ)
- …methodologies that may support innovation and improve efficienciesEngage with regulatory authorities on compound/indication level discussionsActs as a role ... requiring advanced statistical methodologies/techniques Represent the CDT/the company at regulatory meetings, during Key Opinion Leaders meetings, network and/or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …File (eTMF) and other pivotal documents to be submitted to the regulatory authorities for application Qualifications: Successful candidates will be able to meet ... with involvement in regulated clinical trials, clinical safety, pharmacovigilance included regulatory document reviewMust have at least 4 or more years proficiency… more
- Genmab (NJ)
- …Manager to help us tell the story of our science through compelling clinical and regulatory documents. You'll be at the heart of a team that plays a critical role ... development of high-quality clinical documents to support operational, medical, and regulatory activities across the Genmab portfolio. You will help craft… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …this position possesses advanced knowledge of clinical operations and relevant regulatory requirements. This position has advanced experience working on Phase I-IV ... therapeutic areas and is capable of leading DM activities to support regulatory submissions and inspections. Finally, this position has advanced skills in continuous… more
- ADC Therapeutics SA (New Providence, NJ)
- …FDA regulatory inspection for the study. Additional experience with international regulatory agency inspections preferred. *Experience with PV Quality ... the strategy to ensure compliance with Good Clinical Practice (GCP) and regulatory standards. This role requires substantial experience with US and international… more
- HRU Inc Technical Resources (Falls Church, VA)
- …and process federal license and registration applications. - Register with relevant US and international regulatory bodies as required. - Interface with US and ... : $130,000-$145,000 About the Role Are you passionate about regulatory compliance and making a real impact in the...compliance efforts company-wide. As our expert in US and international regulations, you'll ensure that the company operates with… more
- Tris Pharma (Monmouth Junction, NJ)
- …anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the US We also ... and assurance of compliance with GxP and other company and regulatory agency procurement policies and procedures throughout the organization. Ensures compliance… more
