- Merck & Co. (Rahway, NJ)
- …Regulations, Management Process, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance , Regulatory Compliance , Regulatory Labeling, ... experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement experience… more
- Merck & Co. (Upper Gwynedd, PA)
- …(BLA), Electronic Common Technical Document (eCTD), Immunochemistry, International Regulatory Compliance , Microbiology, Molecular Microbiology, Pharmaceutical ... Process Development, Regulatory Affairs Compliance , Regulatory Affairs Management, Regulatory CMC, Regulatory Strategy Development, Regulatory … more
- Merck & Co. (Rahway, NJ)
- …and effective implementation and oversight model to maintain best in industry regulatory compliance .The Vice President Regulatory Affairs, General Medicine ... activities in the US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy.Providing quality advice to… more
- Crdit Agricole CIB (New York, NY)
- … / Financial Security Job title Head of Investment and Corporate Banking Regulatory Compliance ("ICBRC") Americas - Director Contract type Permanent Contract Job ... summary Summary: The Investment and Corporate Banking Regulatory Compliance ("ICBRC")- Americas is responsible for the regulatory Advisory function and the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …years with focus on pharmaceutical regulatory affairs, incl. familiarity with regulatory compliance frameworks (eg, ICH, FDA, EMA) (Required)2 or more years ... on a consistent basis and identifying areas of potential non- compliance or operational risks.Responsibilities:Maintain regulatory procedural documentation, in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …while ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This ... electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards.… more
- Amazon (Reading, MA)
- …rewarding, fulfilling and fun. Amazon Robotics is seeking a safety focused Regulatory Compliance Engineer with experience fielding industrial machinery with an ... position will lead new and existing product development work related to regulatory compliance and safety. The ideal candidate will be a highly organized team… more
- COMPLIANCE TESTING LLC (Mesa, AZ)
- Now Hiring ISO 17025 Regulatory Compliance RF Test Engineers TIC Industry aka. Testing, Inspection, FCC-CE Certification of Wireless & Connected Devices Full or ... Are: Established in 1963, CT is Arizona's oldest, largest & fastest growing regulatory compliance test lab. We are accredited regulatory bodies like the FCC,… more
- System One Holdings, LLC (Cranbury, NJ)
- Job Title : Food Safety & Regulatory Compliance Specialist Location : Cranbury, NJ Hours / Schedule: Monday - Friday, 8am - 4pm, onsite Type: Direct Hire ... Responsibilities The Food Safety & Regulatory Compliance Specialist is responsible for managing and coordinating food safety and quality systems while ensuring … more
- Pernod Ricard (Louisville, KY)
- …on regulatory strategy in order to fulfil business objectives. Provide regulatory compliance support for NADL and Corby brands on labeling, manufacturing, ... marketing, and testing protocols. Evaluate and provide the regulatory compliance assessment for raw materials and finished products according to TTB and other… more
- Merck & Co. (Rahway, NJ)
- …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Abbott (Alameda, CA)
- …submission and approval requirements. Participate in risk benefit analysis for regulatory compliance . Assess the acceptability of documentation for gap ... upon regulatory changes. Participate in risk benefit analysis for regulatory compliance . Monitor impact of changing regulations on submission strategies.… more
- Merck & Co. (Rahway, NJ)
- …in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Strategic Leadership and Project ... performance of team members, fostering a collaborative and innovative team environment. Regulatory Compliance and Quality Assurance:Ensure that all activities are… more
- Merck & Co. (Durham, NC)
- …Multi-Management, People Leadership, Physical Sciences, Production Management, Project Management, Regulatory Compliance {+ 2 more}-Preferred Skills:Job Posting ... North Carolina.- The Durham EHS Lead influences site leadership ensuring compliance with regulatory requirements, corporate standards, policies, and procedures… more
- Merck & Co. (North Wales, PA)
- …Trials Analysis, Data Analysis, Data Management, Data Science, Numerical Analysis, Physiology, Regulatory Compliance , Regulatory Requirements, Regulatory ... design, computing software and data management; a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/… more
- BioAgilytix (Durham, NC)
- …and rule-based checks to identify data discrepancies in real-time, enhancing regulatory compliance and minimizing errors.Independently design and configure basic ... that boost lab productivity and keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a foundational data… more
- Formation Bio (New York, NY)
- …early development through commercialization. You will oversee internal and external teams, ensure regulatory compliance , and play a key role in scaling our ... development, formulation, analytical methods, and technology transfer to manufacturing sites. Regulatory Compliance & Submissions Ensure all CMC activities… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the ... reporting for DSI products, both investigational and marketed. Maintains compliance with Global PV regulations for individual case safety...management of PV Regulatory Intelligence (PVRI) and dissemination across CSPV stakeholders for… more
- Merck & Co. (North Wales, PA)
- …Guidelines, Life Science, Medical Writing, Motivation Management, Ophthalmology, Prioritization, Regulatory Compliance , Regulatory Documents, Rheumatology, ... engagements. This includes the ability to:Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing… more
- Merck & Co. (Rahway, NJ)
- …matters.Review process change requests and deviation reports while ensuring regulatory compliance .Education and Minimum Requirements:Bachelor's degree in ... Relationships, Lean Manufacturing, Manufacturing Processes, Manufacturing Support, Pharmaceutical Manufacturing, Regulatory Compliance , Root Cause Analysis (RCA), Stakeholder… more