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- Irvine, CA
new job!

The candidate is responsible for expeditiously developing and processing raw material and product documentation to meet quality requirements within timelines established for product launch and/or timely project completion.The Master Specifications and Documentation department interacts with various Pharmaceutical groups within the organization and departments such as Quality, Global Pharmaceutical Technology, Regulatory Affairs, Operations, Manufacturing (all sites), Procurement (Sourcing),....


Strategic opportunity as North American (NA) Team Leader supporting Analytical/ Synthesis (Methods Development); Product Metabolism, Product Safety (registration); and Regulatory Compliance (EPA). Participate on the Global Leadership Team while developing a challenged, problem-solving analytical team responsible for performing/ delivering scientific studies to ensure a sustainable product safety and registration success. The successful candidate will have a strong background in Scientific....


Join a leading global organization in their Product/ Metabolism discovery and safety studies team. Requires Scientific expertise in biological or chemical sciences of environmental, plant or mammalian studies. ---Participate as Lead Scientist with expertise in Data Chemistry, analysis testing utilizing Chromatography and other relative methodology. ---Support the use of data sets to optimize study design and overall understanding of the compounds behavior ---Manage studies placed with external


Plant Quality Manager -- Dairy Product Manufacturing -- SQF -- Excellent Salary, Benefits and relocation assistance This opportunity is with one of our finest client companies. We have placed many people with this firm over the years who have found an unexcelled career opportunity here. Continuous expansion, another new plant opened recently, very much in demand traditional food products! GENERAL DESCRIPTION of the Quality Manager position: The Plant Quality Manager oversees all Quality....

- Indianapolis, IN
new job!

TITLE: Director Blood Bank-Med Tech LOCATION: Indianapolis, IN Are you considering a career change? Would you be interested in living in a large city that doesn't feel like it. The Indianapolis area has something for everyone. If so, an opportunity to work an established organization that serves several locations in Indiana is looking for someone to join their team. Summary The Blood Bank Network Administrator assists in development of data-driven pre-analytical, analytical, and....

- Pasadena, CA
new job!

The candidate for this position is responsible for coordinating in-house data management activities (including vendor management) to ensure the accuracy and consistency of clinical databases for subsequent analysis and reporting. In addition, the position is responsible or building programs to create data-sets, listings, tables and figures from clinical databases, external data sources, and other sources. Responsibilities: Receive data from external data sources. Prepare data reports, tables....

- Irvine, CA
new job!

The Associate will be responsible for supporting CTM/OSL and ensuring that all assigned clinical study(ies) are running on time and on budget and are completed in compliance with all relevant laws, regulations, and regulatory guidelines as well as all policies and procedures. Requirements: Bachelor’s degree or higher (science degree preferably in science or health-related field) Previous experience of working on a clinical study 1-2 year relevant experience in pharmaceutical industry or CRO....


Job Title: Specialty Pharmacy Director Location: Baltimore, MD PRINCIPAL ACCOUNTABILITIES: The position reports directly to the Senior Director of the Pharmacy Evaluation & Oversight and is a critical leadership position within the unit responsible for understanding the specialty marketplace, opportunities for utilization management, and cost containment. The Director of Specialty Pharmacy will interact frequently with the EVP of Medical Affairs, the CEO, and other senior leaders across....


Location: San Diego, CA Employment Type: Permanent Context: Our client ss is seeking a Sr. Project Manager to manage research and drug discovery projects from the research/discovery phase through to early clinical development. Preference will be given to candidates who have experience with small molecule therapeutics. The ideal candidate will be an innovative, highly motivated project manager with a strong scientific background in preclinical drug discovery research and project management. The


Los Angeles, CA Currently looking for an experienced Manager, Regulatory Affairs - CMC to fill an opening with a Fortune 100 Pharmaceutical Company located in Los Angeles, CA. Interested candidates should hold a Bachelor’s Degree (Regulatory Affairs, Life Sciences, or Engineering) and have 6+ years’ regulatory and/or compliance experience. Responsibilities of the Manager, Regulatory Affairs - CMC Responsible for generation of the region-specific regulatory documents Clinical Trial....

- Cambridge, MA

Regulatory Affairs Advisor - Medical Device Cambridge, MA Overview: Our client is a leading provider of consumer, business-to-business, and industrial digital imaging solutions to the United States and to Latin America and the Caribbean markets. They are committed to the highest level of customer satisfaction and loyalty, providing 100 percent U.S.-based service and support for all of the products it distributes in the United States. They are currently seeking a Regulatory Affairs Advisor for....


Title: Director of Regulatory Affairs Direct Reports 2 Mgrs Indirect Reports: 8 -10 Responsible for coordinating quality regulatory submissions to the United States Department of Agriculture’s (USDA), specifically The Center of Veterinary Biologics (CVB), and following USDA licensure, coordinating dossier submissions to regulatory authorities in countries, including affiliates and distributors. Manage US Regulatory Affairs Department:Manage and oversee licensure of new products in the US.....

- Any US State

RETAINED SEARCH - Dir Regulatory Affairs - Safety & Efficacy - MUST have Animal Health Pharma experience Prepare Review Reg submissions FDA - CVM - INAD's - CFR - ICH/VICH - RAPS - Prefer Advanced degree or DVM Virtual Office - Work remote


Depending upon experiece, candidate can be located in CA, NJ, MA or even possibly work remotely (case by case basis). The Rare Disease Global Regulatory Team Lead (GRTL) is a Director-level role which is part of the Global Regulatory Affairs (GRA) team based in the US. He/she is responsible for developing long- and short-term regulatory strategies that impact company’s business objectives. Specific responsibilities include: Global Regulatory Team Lead (GRTL) is responsible for developing....


5 openings - must be located in one of the territories TERRITORIES:? IMMUNOLOGY/ONCOLOGY/RARE DISEASE New York Carolinas: Virginia, or North or South Carolina Great Lakes- Michigan or Ohio Chicago – Wisconsin or Illinois or Indiana Minneapolis: MN, Iowa, Nebraska, South Dakota or North Dakota DESCRIPTION:Develop and communicate in-depth clinical knowledge of Immunology and/or Oncology - Rare DiseasesEstablish relationships with opinion leaders, prominent academic and clinical investigators and


Develops and maintains professional relationships with internal and external customers to provide comprehensive medical and scientific support to company initiatives in assigned therapeutic areas. Facilitates information, education, and research activities for physicians and ancillary healthcare professionals regarding current and future therapies in development or commercialized. Works closely with other personnel to ensure information, education, and research needs of healthcare....

- Any US State

Position Summary: The Senior Director, CMC Regulatory Affairs will be responsible for providing CMC regulatory leadership and strategy across the organization and to our global partners. The Sr Director, CMC Regulatory Affairs will collaborate with the clinical development team, including the Chief Scientific Officer and drug substance and drug product manufacturers, and others for drug development and manufacturing in the pharmaceutical and biotech industry in accordance with the protocol,....


This is a neat opportunity! Our client has a food & juice product manufacturing facility in Indiana. They are looking for an experienced Quality Assurance / Food Safety Technician You will be working with all quality assurance and food safety aspects of food processing activities; assist with developing and refining food safety plan for operations, participate directly in continuously improve plan and maintain facility food safety and quality assurance department as a GFSI Practitioner.....


Pharmaceutical company in need of Director or Senior Director to join the Medical Affairs team. The Medical Director will provide support and expertise in the area of psychiatry either Schizo or Addiction as there are two needs In this newly created and high profile role you will serve as the medical affairs strategic lead for our combination oral schizophrenia treatment that is currently in phase 3 clinical development. The Medical Director is expected to establish key medical strategies for....


Position Overview The Sr. Manager will represent Regulatory Affairs for pharmaceutical development projects and marketed products. Working with manager, responsible for development and communication of global regulatory strategy on R&D project teams. Main Areas of Responsibilities The Sr. Manager Regulatory Affairs will ensure technical accuracy and regulatory compliance of all submissions for which they are responsible and ensures that applications are executed appropriately and submitted

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