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- Hopkinsville, KY
new job!

Our Food Safety Manager is responsible for managing our in-house Micro-Lab and implementing and managing process control systems and preventative actions in the food safety area. You will manage all HACCP and Regulatory compliance issues at this processing site. Client company cannot sponsor or transfer Visa's at this time. Qualifications:Bachelor’s degree in Food Science, Microbiology, Chemistry, Biology. An advanced degree is preferred.A minimum of two years’ experience in Food Safety....


Job DescriptionSummary of the Position:Keeps Regulatory Affairs Director appraised weekly of all tasks and projects. Gather documentation and compile materials required for international product registrations. Coordinate with International Product Manager and the International Business Unit a viable timeline for registration approvals with the Regulatory Affairs Supervisor or Director of Regulatory Affairs & Technical ServicesRoles and Responsibilities:Maintains all (electronic/hard) files

- Rockford, IL
new job!

The Compliance Manager will provide a broad range of compliance services in support of Quality Department. Essential Duties and Responsibilities include the following. · Performing periodic GMP/food safety related audits in internal manufacturing and distribution facilities, supplier audits in a variety of food processing/packaging environments, label compliance audits, and maintenance- food safety related performance audits. · Responsible for Managing the Company’s Tracegains System and....

- Cincinnati, OH
new job!

Job Description: Responsibilities include supporting daily compliance and systems activities. Performs audits (internal and vendor audits), supports change control program, complaints and any customer services related to Documentation Center. Also works with manufacturing to identify resolution to events while working with Quality Management. The candidate will perform general QA work, using their ability as a skilled contributor in completing tasks where judgment is required in resolving....

- Parsippany, NJ
new job!

Our client - a growing Pharmaceutical company in Northern NJ - is looking for a Sr. Regulatory Affairs Associate. The Sr. Regulatory Affairs Associate will helps to put together and submit regulatory submissions to the FDA. These submissions will include: ANDAs, Amendments, Supplements, Annual Reports etc. (There may be additional work involving 505 (b)(2) submissions as well.) This position will also involve effective interaction with other departments with regards to the information required

- East Hanover, NJ
new job!

To be considered for this position you must have at least 7 or more years of regulatory affairs experience in the area of In Vitro Diagnostics (IVD) along with hands-on preparation of 510K submissions for IVD products. Strongly prefer someone form the medical device industry (not pharmaceutical mfg). Any experience dealing with face-2-face meetings with regulators (like Pre-Submission meetings) will be considered a valuable asset. Provide regulatory strategies for products, including....

- Newark/Princeton Area, NJ
new job!

Our client, a Fortune 150 Medical Diagnostics Equipment Manufacturer, is looking for a Senior QA Auditor to join Division Team in Central New Jersey area and independently conduct assigned audits to assess compliance to applicable business/division requirements, external standards/regulations and Corporate Quality System requirements across multiple Plants within Division. Participate in audits of manufacturing and commercial affiliate sites.in US and CanadaManage and/or participate in....

- Indianapolis, IN

TITLE: Blood Bank Administrator 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 post-analytical....


Title: Director Regulatory Affairs Oversee Regulatory Affairs (Animal Health) – USA & Canada (SME) FDA audits – Point Player with FDA Regulatory strategy, labeling, and promotional material Facilitate product transfers Degree – Scientific 10+ yrs Reg Affairs Experience

- Any US State

Title: Sr Reg Affairs Mgr Regulatory compliance with relevant regulations managing submissions with regulatory authorities. Ensures compliance with relevant regulations. Manage regulatory documents, pre and post approval.. Education: BS Science Minimum 7+ yrs animal health regulatory experience, Previous relationship with FDA


Join a global leader as a Ph.D. Toxicologist responsible for conducting quantitative risk assessments for agrichemical and fertilizer products and traits in North America. You will provide technical advice on study designs for regulatory and research oriented studies as well as advice to support new and existing registrations of client products and traits. --- Work closely with regional/global regulatory and product safety teams as well as other functional teams to produce risk assessments for


Top Tier Global Pharmaceutical company is expanding and looking for two Study Medical Experts (for Clinical) must be Medical Doctor with MD degree Can have experience in oncology or even internal medicine + endocrinology/rheumatology/gastroenterology/etc and have experience with research. Competitive salary and benefits and bonus, 401k, long term incentives and short term incentives and more Provide medical support for the study team:Global primary contact person during the course of the....


The company is a leading, privately held national food service company serving business and industry, education, healthcare and the entertainment sectors with on-site dining, catering, vending and beverage services. RESPONSIBILITIES: Primary point of contact for all quality assurance and food safety related topics and company liaison to clients and regulatory agencies for safety inquiries, issues and concerns. Process and standards expert responsible for initiatives, development, improvement,....


Summary Description: This position will be tasked with leading regulatory support and expertise to business units regarding requirements for selling products and conducting business Internationally. This role leads the development, planning and execution of regulatory strategies for development, registration and post-authorization initiatives for company in International Markets with Europe being the main focus (including but not limited to: Europe, Asia, South American and the Middle East).....


Head of Product Labeling / Technical Communication Elmsford, NY - Full relocation provided Competitive Pay, Bonus, 4 weeks PTO, 6% 401K, Great benefits We have a new opening for a Head of Product Labeling / Technical Communication with a longstanding client; a multi-billion ($8B+) global medical instrumentation company. They have strong revenue growth, a stable environment, very low turnover, and offer the opportunity to work on customized, complex medical products that impact people's....

- West Los Angeles area, CA

Growing Oncology Clinical Trial site in the west side of Los Angeles has an opening for a Regulatory (IRB) Associate. This is a contract position while the incumbent is on maternity leave. Responsibilities:Will provide support for clinical research protocols, informed consents, etc.Will assist with all aspects of clinical research regulatory to ensure compliance to regulations and protection of human subjectsPrepare and submit documents to the IRBRequirements:Bachelor's degree required1+....


Top Tier Global Pharmaceutical company is expanding and looking for a new AD, Biostatitics Must have heavy statistics experience (ideally in a pharmaceutical or biotech environment. PhD preferred. Salary 130-145k plus bonus , FULL RELOCATION to Irvine, CA Additional financial incentives- Short term incentives, Long Term incentives and stock, tuition reimbursement The Associate Director, Biostatistics position can independently lead one or more projects ensuring the proper design, analysis, and


Regulatory Affairs Team Lead New Jersey Massachusetts Our client, a global pharma company has a new opportunity for a Team Lead level professional with Regulatory Affairs/Oncology expertise to drive US and Global Oncology projects. This is a full-time Team leader level role driving regulatory strategy of oncology drugs. Independently manages all regulatory business strategies for oncology products throughout lifecycle. Responsible for the regulatory strategy of submissions for all products as....


Key Responsibilities:Coordinate, assemble and/or prepare for submission various materials to the FDA such as ANDAs/supplements, periodic reports for approved products. Assist VP to lead all interactions with regulatory agencies.Point of contact to local regulatory authorities and maintain the communication system.Serve as the Regulatory Affairs representative on project teams and assure the progress of projects by providing direction, solutions and feedback to the teams.To have overall....


Assoc Dir, Toxicology Top tier global pharmaceutical company and a leader in a new industry model – Growth Pharma focused on developing, manufacturing and commercializing branded pharmaceuticals and biologic products for patients around the world. Company markets a portfolio of best-in-class products that provide novel treatments for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology, anti-infective and cardiovascular therapeutic

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