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Global Pharmaceutical company with high profile trials is expanding and looking for a Director, Regulatory Affairs for their Global Management Team Competitive base salary and bonus, full relocation and benefits, Long Term Incentives and more Position IDEALLY is located in the Cambridge, MA office (there is small possibility the role can be based in their NJ office) The Rare Disease Global Regulatory Team Lead (GRTL) is part of the Global Regulatory Affairs (GRA) team based in the US. He/she....


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....

- Clearwater/St. Louis, MO, FL

Global Leader in Pharmaceuticals and Medical Devices is expanding in their Regulatory Affairs High Profile Division- Medical Device/CMC Position can be located in either the St. Louis, Missouri office or their Clearwater, Florida office relocation is provided Candidate MUST have Medical Device experience and must have written CMC submissions in the past (recent past is preferred) Individual Contributor role competitive base salary, plus bonus, full benefits and other Long Term Incentives.......


Great opportunity to join a Global Company as the strategic North American (NA) Team Leader supporting Analytical/ Synthesis (Methods Development); Product Metabolism, Product Safety Standards; 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


Our client is a major worldwide consumer products company, ranked in the Fortune 200. Indeed.com identified them as one of 25 of the biggest and brightest corporations that are going the extra mile to help employees achieve the elusive “work-life balance.” Fortune Magazine identifies them as one of the top 50 World's Most Admired Companies. Position Summary: This key corporate food safety position plays a critical part by participating in strategic planning & addressing major Company....


Global Pharmaceutical Company out of Madison, NJ and Irvine, CA Position Summary: (Irvine, CA or Madison, NJ) Responsible for leading internal and outsourced Clinical Programming activities in support of Clinical Research studies and managing the design, development, validation, implementation, and oversees ongoing support to electronic case report form (eCRF) systems (e.g. InForm, etc.), external data acquisitions, reporting/business intelligence tools (e.g. SpotFire, J-Review), and other....


High Profile Drug Development Pharmaceutical Company is expanding: Global Category Director- Drug Development Services Are you looking for a patient-focused, innovation-driven company that will inspire you and support your career? If so, be empowered to take charge of your future Join us as a Global Category Director – Outsourced Drug Development in our Cambridge, MA office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Global Category Director

- Lancaster, SC

Summary of the Position:. Develops and deploys the quality system for entire manufacturing facilities to assure systems and procedures are compliant pursuant to government regulations, industry standards and Company specifications and policies. Periodically reviews the suitability and effectiveness of the quality systems with Executive Management. He/She has ultimate responsibility for making the quality decisions on the identity, purity, strength or composition of nutritional products in the....


Our client is a producer of Bio-pharmaceuticals. They have developed core competencies in the development of processes and products derived from natural sources both animal-based and plant-based. They have an immediate opening for a Regulatory Affairs Specialist. RESPONSIBILITIES:This position will provide regulatory support for development and commercial programs.In this role, you will plan, coordinate and oversee regulatory activities.These activities include the preparation of document....


Global Pharmaceutical company in Northern NJ is expanding and is looking for Packaging Mechanic Serialization Our company is a niche pharmaceutical company that develops, manufactures and markets generic and branded prescription pharmaceuticals as well as animal and consumer health products. We specialize in difficult-to-manufacture sterile and non-sterile dosage forms including: ophthalmic, injectables, oral liquids, OTCs, topicals, inhalants, and nasal sprays. We market our products to....


Global Pharmaceutical company is expanding: OBJECTIVES: - The Project Manager is required to identify and resolve project risks with proposed resolution plan (ad hoc and planned), with escalation to senior stakeholders where appropriate. - They will execute their day-to-day activities in line with company Category Management Framework, with a strong focus on strategic sourcing initiatives which aim to qualify and select suppliers that meet the needs of the business at maximum financial....


DIRECTOR / 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.....


This is a key position that will have product development oversight responsibility for Design Control as the product moves through the development stages to commercialization. Key liaison between Product Development, Quality Engineering, and Regulatory Affairs. Maintain focus on VOC requirements as defined by Marketing. Required Background & Experience:MEDICAL DEVICE PRODUCT DEVELOPMENT EXPERIENCEBS degree in a technical discipline, preferably engineering. Advanced degree is a plus.Strong....


New contract role (opportunity to convert to perm in future if desired) with Global Pharmaceutical company located in Cambridge, MA BACKGROUND: This Drug Product is an ALK Inhibitor for the treatment of patients with anaplastic lymphoma kinase-positive (ALK+) metastatic NSCLC. It was recently approved by the FDA under Accelerated Approval in April 2017, based on tumor response rate and duration of response, for previously treated anaplastic lymphoma kinase-positive (ALK+) metastatic....


Our mid-sized client is looking to add a Principal and Sr. Compliance Specialist to add to their growing team. The main responsibilities will be Field Corrective Action (FCA) and Recall Management for Medical Devices. Will be leading teams to develop field corrective action and recall plans. Oversee execution and reconciliation of field corrective actions and recalls. Working with cross-functional partners to determine root cause and population bounding as well as with Health Hazard....

- Bessemer, AL

Sr. Process Engineer - Full relocation benefits to near Northport/ Tuscaloosa/ Bessemer/ Birmingham AL The Sr Process Engineer reports directly to the VP of Manufacturing with plenty of autonomy and responsibility for a Chemical Engineer and “jack-of-all-trades in a chemical plant. Since this is a small plant, there will be duel technical and leadership responsibilities. Why might this be a good career move? Their future is bright: They make a very high demand product used in a large variety....


Job Summary: Provides technical support for variety of activities related to new product development, product reformulations and other regulatory issues as they arise. Main focus of this position is to be the business partner between Regulatory Affairs and Product Development to address situations that arise on documentation for preliminary formulations, ingredient statements, nutrition and claims. Responsibilities:Serves as the point person for Regulatory Affairs and Research and Development....


Reporting to the Director of Regulatory Affairs, this key role is to function as global lead on device teams. Ensure that submission content meets regulatory requirements. Strategize to identify risk areas and develop alternative courses of action. Manage scenario planning and development of regulators responses. Manage medical device Regulatory Affairs activities for developing global CMC medical device and IVD strategies across product life cycles & execution in North America. Support....

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