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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

- 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....

- 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....


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

- Greensboro, NC
new job!

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....


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....


SENIOR DIRECTOR, REGULATORY AFFAIRS – CMC Our client, a progressive biopharmaceutical company, has a new opportunity for a Senior Director level Regulatory Affairs professional with CMC expertise in the San Francisco Bay area, to drive US and Global Regulatory projects. This is a full-time Senior Director level role with a primary focus on the discovery and development of oncology drugs. Independently manages all regulatory CMC business for oncology products throughout lifecycle. Senior....


Top tier Pharmaceutical company (one n Boston and one in NJ nd one in Seattle)Required:Has completed management of a study or group of studies from planning through close out (Phase 3)Experience with managing VendorsExperience working on global studies with CROs Nice to Have:Experience supporting writing clinical study reports,Supporting sNDA or NDA submissions, Supporting pre-Inspection preparation,Participating in Sponsor Inspections by Regulatory BodiesExperience managing or leading teams....

- Marlborough, MA

Top tier Pharmaceutical and Chemical Company in Marlborough, MA is expanding a 6 month full time w-2 contract with benefits (can be renewed up to 4 years) is looking to hire a Data Quality Facilitator This position is responsible for maintaining and/or creating customer contact data content in accordance with established guidelines within Hologic systems. The Facilitator is responsible for supporting the data quality strategy which is to ensure data integrity through data governance. The....

- Houston, TX

Relocation assistance is available. RequirementsAdvanced degree in a scientific field.8 or more years experience as a Medical Affairs Manager, in medical device industryManagement of investigator initiated researchExperience developing and managing project schedules, costs, and maintaining quality.Knowledge of neuromodulation, cardiac surgery and/or cardiac rhythm management is be a plus but not a must!Duties You will lead the development and maintenance of all published and unpublished....


* Develop and oversee clinical teams to conduct IDE studies, including monitoring oversight of the clinical studies.* Prepare study sponsors for BIMO audits.* Experience should include clinical trial planning, audit preparation training, preparation and submission of study protocols, IDEs, PMAs annual and technical reports; SOP development reporting, post market surveillance, data management, computerized data entry, database development, informed consent and care report form (CRF)....


Top Tier Progressive Bio Pharmaceutical company with offices in Seattle and San Francisco is expanding They are looking to hire a Director of Regulatory Advertising and Promo Description Company rates #1 in Northwest! They are a clinical-stage company developing novel cellular immunotherapies based on two distinct and complementary platforms – Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. Our goal is to revolutionize medicine by re-engaging the body’s immune....

- 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+....

- Bessemer, AL

This is an opportunity for Chemical Engineer to contribute in a highly profitable plant that manufactures a very high demand chemical product serving a global market. The Process Engineer reports to the Site Manager with plenty of autonomy and responsibility for a Chemical Engineer to become a “jack-of-all-trades in a chemical plant. Eventually, after some on-boarding, training and mentoring, this person will be a lead engineer responsible for day to day plant performance in such areas as....


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

- Parsippany, NJ

Our client - a growing Pharmaceutical company in Northern NJ - is looking for a Sr. Regulatory Affairs Associate. The 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 for


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

- Newark/Princeton Area, NJ

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....

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