- 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
- 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
- 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
- Insmed Incorporated (San Diego, CA)
- …calibration and maintenance systems to ensure operational readiness and regulatory compliance. Responsibilities include leading the procurement, installation, and ... and execute C&Q plans in compliance with internal procedures and regulatory standards.Lead CMMS implementation and maintenance, including asset setup, scheduling of… 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
- 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
- Genmab (NJ)
- …other analyses not pre-defined in the SAP), answers to questions posed by regulatory authorities or ethics committees, answers to in-house questions related to data ... relevant therapeutic and professional areasMaintains up-to-date knowledge on relevant regulatory guidelines/requirementsMaintains a good working relationship with stakeholders and… more
- Merck & Co. (North Wales, PA)
- …reimbursement and market access, and provides input into clinical, regulatory , payer/access, marketing and evidence generation strategies and programsIn ... scientific experts worldwidePresents outcomes research data at national and international congresses and publishes articles in scientific journalsRequired Qualifications,… more
- Merck & Co. (Rahway, NJ)
- …reimbursement and market access, and provide input into clinical, regulatory , payer/access, marketing and evidence generation strategy and programsIn collaboration ... scientific experts worldwidePresents outcomes research data at national and international congresses and publishes articles in scientific journalsRequired Qualifications,… more
