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Our client, a small start-up company who was recently recognized as an award-winning Top Workplace is looking to add to their growing team. The Principal Regulatory Specialist will be working on a variety of worldwide pre-market and post-market regulatory activities. The first project will be working on the early (concept) stage of a submission. Responsibilities: - Support the Senior Manager of Regulatory in developing a partnership with other departments in designing and enhancing regulatory....

- Cambridge, MA

Fast growing, high profile Pharmaceutical company in Cambeidge is expanding!!! MUST BE STRONG COMMUNICATOR AND SELF STARTER WITH PRIOR CLINICAL DEVELOPMENT BACKGROUND You would be glue that holds our clinical programs together in many ways. You will use your strategic insights to provide scientific support for many clinical activities, and help us build clinical expertise in a new therapeutic areas. Forming close partnerships with clinical operations, you’ll employ your expertise to mentor and

- 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....


QUALITY ASSURANCE MANAGER Our QA Manager is responsible for leading the Plant Quality and Sanitation teams directing the daily operations of the Quality Assurance and Sanitation function to uphold company policies, formulas, specifications and regulatory requirements, as well as ensures that all finished product meets food safety and quality standards. Requirements:Bachelor's degree in Food Science, Chemistry, Biology, Microbiology or a related discipline.Certifications in SQF, HACCP, and....

- 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....


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

- East Hanover, NJ

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....


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....


Senior Clinical Data Manager, CDM - San Francisco Bay Area Ideal candidate will be onsite in the San Francisco Bay area. Will consider remote with travel into the office for meetings, etc. Candidate must be on the west coast preferably: San Francisco Bay area, Seattle, Los Angeles, San Diego. Our client, a progressive biopharmaceutical company with multiple trials in Phase I-III, has a new opportunity for a Senior Clinical Data Manager professional with oncology expertise in the San Francisco....


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....


Senior Clinical Research Manager Elmsford, NY or Glasgow, DE (Relocation Provided) Competitive Pay, Bonus, 4 weeks PTO, 6% 401K, Great benefits We have a new opening for a Senior Clinical Research Manager with a longstanding client; a multi-billion ($8B+) global medical diagnostics/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 lives. A lot of....

- 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....

- Seattle, WA

Senior Medical Director - Seattle, WA Job descriptionPosition Purpose: Assist the Vice President of Medical Affairs to direct and coordinate the medical affairs functions for the business unit. Oversee the denials and appeals department. May manage other medical directors. Assume VPMA responsibility in absence of VPMA. Provide medical leadership for all utilization management, pharmacy, case management, disease management, cost containment, and medical quality improvement activities. Perform....


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


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....


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....


This position serves as the senior liaison between physicians and the company regarding technical issues. This encompasses, IDE clinical trials, troubleshooting and future product features. The incumbent is expected to act as a mentor for Field Clinical Engineers. The FCE collaborates with Regulatory, QA and R&D.Neuromodulation for chronic pain technology. Hugely successful IPO with a company market valuation currently over $2 billion USD. Ideal candidate will have Neuro and Cardiology....

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