- Merck & Co. (Rahway, NJ)
- …experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement experience ... experience in System Development/Management within Manufacturing or Research areas preferred. Start date: -As soon as possible.Job Description: Seeking a full-time… more
- Merck & Co. (Rahway, NJ)
- …formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products ... product technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory … more
- BioAgilytix (Durham, NC)
- …clear governance so everyone knows who can see or change each dataset. You'll start as a "player-coach," doing the technical heavy lifting yourself while laying out ... that boost lab productivity and keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a foundational data… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for new instrumentsResponsible for working with groups to provide start -up, commissioning, and qualification/validation support of instrumentation and systems ... and collaborating with key stakeholders and functionsActively participates in all regulatory and internal audits of the facilityPartner and manage relationships with… more
- Merck & Co. (Rahway, NJ)
- …process change requests and deviation reports while ensuring regulatory compliance.Education and Minimum Requirements:Bachelor's degree in engineering, chemistry ... work experience in manufacturing or development, in the areas of process start up, technology introduction, manufacturing and/or technical transferA minimum of 7… more
- Aequor (Hicksville, OH)
- …Starts up production lines at the beginning of the shift and at the start of batches to release lines. Monitors lines including correct weights, lot number, ... to all applicable procedures, cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.). Ensures all work… more
- Eisai, Inc (Nutley, NJ)
- …across HCPs, Consumers, and SOC to drive adherence and safety as patients start therapy. Partner with Market Access, Eisai Patient Support, and our Specialty ... project teams involving Marketing, Sales, Managed Markets/Market Access, Legal, Regulatory , Medical, PR, agencies, actively soliciting team expertise and input… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Market Access and Public Affairs (MAPA), Field Sales, Commercial Excellence, Regulatory Affairs, Integrated Customer Engagement, Global and other relevant NNI ... business development opportunities Identify and establish strategic partnerships with start -ups, technology companies, and other external partners across diagnostics,… more
- City of Spring Hill Kansas (Spring Hill, KS)
- …paid leave, holiday pay, KPERS retirement and a City of Spring Hill Retirement package. Start a great new career with the City of Spring Hill. Pay, Education & ... judgement and simultaneously considering the financial, ethical, legal and regulatory variables that affect the City is vital. Performs...retirement and a City of Spring Hill Retirement package. Start a great new career with the City of… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …the design and implementation of manufacturing processes, instrumentation, and equipment start -ups from the laboratory through manufacturing scale. This role will be ... actions and related issues Coordinate fabrication, procurement, installation, engineering start -up, and validation activities of new equipment and systems, including… more
- AUROBINDO (Durham, NC)
- …support and expertise of our parent organization has given Aurolife a jump start in building a solid pharmaceutical portfolio very quickly. The Aurolife family ... with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a… more
- AUROBINDO (Durham, NC)
- …support and expertise of our parent organization has given Aurolife a jump start in building a solid pharmaceutical portfolio very quickly. The Aurolife family ... with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a… more
- AUROBINDO (Durham, NC)
- …support and expertise of our parent organization has give Aurolife a jump start in building a solid pharmaceutical portfolio very quickly. The Aurolife family ... with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a… more
- Eisai, Inc (Nutley, NJ)
- …Trial Assistant will support all phases of clinical study activities (feasibility, start -up, conduct and close-out) under the direction and supervision by study ... action Item follow-upAttends CRO and vendor teleconferences as applicableReview regulatory packet for investigational product releaseProvide user access management… more
- University of Miami (Miami, FL)
- … Analyst II reviews, prepares, and provides oversight for initial and subsequent regulatory submissions from study start -up through study closure as well as ... the maintenance of regulatory documents to ensure compliance with applicable requirements and...the process of study submissions (initial and amendment) and regulatory document maintenance; serves as point of contact for… more
- Adecco US, Inc. (Detroit, MI)
- …+ Support children's social-emotional, physical, and cognitive development + Maintain regulatory compliance with Head Start Performance Standards and local ... **Head Start Teacher** **Location:** Detroit Metro Area (multiple early...and resources. **Job Summary** Adecco is hiring full-time **Head Start Teachers** in the Detroit metro area. This is… more
- University of Pennsylvania (Philadelphia, PA)
- …the initiation of Phase I-V clinical trials with a focus on required regulatory start -up approvals and associated site initiation documentation. Reporting to ... Temporary Employee - Non-Exempt Job Description Ophthalmology seeks a part-time Regulatory Affairs Start -Up Specialist-CC to facilitate, with minimal supervision… more
- University of Washington (Seattle, WA)
- …position requires some independent decision making in all aspects of the research study start up process as well as ongoing regulatory study maintenance. This ... position will be responsible for expeditious coordination of the regulatory submissions in the study start -up phase...of the regulatory submissions in the study start -up phase to meet sponsor and institutional timelines, which… more
- Arkansas Children's (Little Rock, AR)
- …and stakeholders. *Provide training and guidance to study teams on start -up procedures, regulatory requirements, and institutional workflows. *Collaborate with ... Full time **Department:** CC033020 Clinical Research Operations **Summary:** The Study Start -Up Project Manager serves as the institutional lead and subject matter… more
- Abbott (Abbott Park, IL)
- …Contracts Associate), as needed. Manage all aspects of study lifecycle to include site regulatory and quality: + Start Up + Nominate, approach, and complete ... aspects of the start -up process and site initiation visits + Understand regulatory and legal requirements for study participation at a level that allows for… more
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