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- Southwest USA, ON
new job!

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

- Winston-Salem, NC
new job!

This world class chemical client is seeking postdoctoral scientists to develop new models and algorithms in the area of Supply Chain and Production optimization, transportation, planning and logistics to improve the sustainability of products and our business in line with the Growth Plan. In this position, you will have the opportunity to help shape how the clients approaches complex problems such as demand forecasting, product placement and supply optimization. Responsibilities: --- Create....


Process Development Engineer – Solids Processing Location: Suburban NY close to NYC and North NJ Here's an opportunity to make a big impact with zero “corporate red tape”. Get in near the ground floor in this established and well-funded startup company. They are working to develop a “Green” source of traditional petrochemicals used to make plastics! Your success in this position is a key step in the overall company’s success. In this role, you will be a big-fish in the small pond. Let’s start....

- Greenville, NC
new job!

Excellent opportunity for Sr. Chemist to supervise and direct a staff of 6 Laboratory Technicians, conducting non-routine analyses and analyses on substances as part of research projects to evaluate chemical and physical properties. Will provide technical expertise for commissioning and support of all laboratory analytical systems/ instruments (ICP-OES, GC, XRF, N-TOC, IEC, Colorimetry, and Density Meters), promoting the accuracy of analytical data, optimum productivity. Responsibilities....

- 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....

- San Francisco, CA
new job!

Vice President, Regulatory Affairs San Francisco Bay Area Our client is seeking a Vice President, Regulatory Affairs who will be responsible for regulatory strategy, oversight, and guidance drug development program. The successful candidate will bring strong leadership abilities to oversee the Regulatory Affairs team, a successful history of effectively leading IND and NDA filings through approval, and interacting effectively with the FDA and other foreign regulatory bodies. This position....

- Buffalo, NY

Provides quality oversight to the Chemistry & microbiology laboratories and product transfer by supporting all work. Work in partnership with the aforementioned groups to produce quality work in compliance with all applicable regulations. - Review/approve deviations, OOS's, OOT's, EE's, and change controls. - Perform audits of the chem & micro labs. - Review/approve protocols, investigative studies, raw data and reports. - Establish and control quality programs to ensure conformance....

- Cincinnati, OH

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....


The positions serves as the site’s Oral Solid Dosage (OSD) platform leader and reports directly to the Sr. Director of Process Development. Responsibilities include management and oversight of multiple early and late stage development projects and support personnel. Job Functions: Demonstrates technical expertise in OSD technology and methodologies. Lead site related process development, scale-up, commercialization and tech transfer responsibilities Collaboratively develop project strategies....


Company is seeking a Principal Engineer to lead projects in the Biologics process development and clinical manufacturing projects. The individual will design, develop, scale-up and optimize drug substance and drug product unit operations for protein therapeutics. Experience managing projects from Discovery integration through GMP manufacturing, with both internal and external partners are required. The candidate should have strong technical, communication and interpersonal skills, be able to....


POSITION SUMMARY: Working with minimal supervision, manage complex projects/products, including responsibility for the content, assembly, pre-final review, and filing of major medical device applications (e.g., IDEs, PMAs, 510(k)s) submitted to the FDA and foreign regulatory agencies. Applies regulatory expertise to the evaluation and solution of product development issues. SPECIFIC DUTIES AND RESPONSIBILITIES: - Draft, assemble, and file original documentation and submission materials for new

- Any US State

Our client needs a doctor with experience in oncology clinical drug development to serve as a medical monitor. Work is estimated to take 10 hours per week to start.RequirementsMedical Doctorate (MD) or equivalent5 years clinical drug development experience in oncologyPhase 1 and phase 2 studiesResponsibilities1. Available to clinical investigator sites as a go-to person in the US for checking eligibility2. Be responsible for interacting with sites on safety management of the study. This will....


Join a global leader as a Eco-Toxicologist responsible for conducting quantitative environmental 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....

- Los Angeles, CA

Grow your career while working and being trained in the exciting field of Oncology Clinical Research. This opportunity is for a large growing clinical trial site in W. Los Angeles. Requirements:*Experienced Oncology Nurse (RN required, OCN is a plus) *CA License*Must be able to follow the protocol and see that it is followed*Good communication skills and work well with patients and doctors *Full-time Mon-Fri *Must be commutable to W. Los Angeles Responsibilities may include: - Screening....


Top tier growing Global Pharmaceutical company is looking for a vibrant and sharp Manager of Regulatory Affairs to join their dynamic Team The is company has been named top new Pharma and one of the Best Employers in 2017 The role canbe in EITHER their Seattle, WA HQ or their NEW offices in San Francisco (full relocation package offered- And great benefits too) Must be a self starter with initiative and Regulatory Affairs experience in the Pharma industry- must have Regulatory affairs and CMC....


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....


Plans and coordinates the marketing and promotional campaigns for assigned veterinary product lines. Provides leadership to Associate Product Managers at the direction of the Marketing Manager. Assists Marketing Manager with overall Marketing Strategy, to ensure all company directives are met.Responsibilities include:Must endeavor to be an “expert” in the knowledge of the products you are managing as well as the channels where they are soldCreates project timelines for assigned....


***Must have a Science background, this is not a business development role*** Job DescriptionReports directly to Vice President of Research & Development for investigation of ingredients and product sourcing. Provide scientific assessment of new or existing active ingredients. Investigate formulations and assist formulators with ingredient sources and dosing.Roles and Responsibilities:Assist in the development of new products for the Veterinary Division, including rationale, project....


Traditional SHE leader's role dealing with a Chemical manufacturing facility.Lead the plant’s safety, health, environmental and security programs, as well as the operation of the Utilities function. Take the lead on all compliance with all safety and environmental regulations and policies. Lead effort in compliance with environmental regulations, permits and reporting requirements. Responsible for the operation of the Utilities department (steam function, waste treatment, and electric....


My client is expanding and looking to hire a Director for their Medical Affairs group. The ideal candidate will take on the following responsibilities:Direct collaborations with academic, pharma and biotech partners and facilitate work with biotech Directors and VPs, academic PIs, and others.Understand the research and drug development needs of existing partners and ensure exceptional service.Develop and expand research and clinical collaborations with new partners. The ideal candidate will....

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