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Open CMC (Pharma) position ... Direct technical CMC for drug development projectsHands on Formulation / Process DevelopmentPost approval maintenance of productsTroubleshoot manufacturing with CDMO's Assess manufacturing changes Maintain CMC, DMF, GMP-QA electronic filesStrong chemistry backgroundHow studies need to be runResponsible for preparation of post approval supplements and other regulatory documents PhD, MS or BS Exp: 5+ yrs


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.....


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....


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....


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


Global Pharmaceutical company in Madison, New Jersey is looking for a Pharmacovigilance Agreements & Alliance Management Specialist We are looking for candidates with a PharmD or RN/NP with individual case safety report processing experience and knowledge of global drug safety/PV regulations, i.e., Drug Safety Associate/Sr. Associate/Manager. I. POSITION SUMMARY: The PV Agreements & Alliance Management (PAAM) Specialist guides and facilitates effective working relationships with....


New need for Growing Global Pharmaceutical Company in New Jersey Contract R&D Project Planner III This R&D Project Planner is responsible for supporting Clinical Trial/Project Teams by strategically developing and maintaining clinical study timelines, providing evaluations of potential risks and conflicts, supporting the team on proactively resolving potential deviations, and presenting clear timeline reports. PP will work in a team orientated environment and is empowered to drive....


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....


Medical director needed for Global Pharmaceutical company with US Headquarters in Massachusetts The role of the Medical Director, GPSI–US is to provide medical management and leadership for processing and analyzing safety reports for assigned compounds. The role is responsible for the overall safety assessment, pharmacovigilance activities, US label review, US periodic aggregate reports, and regulatory reporting activities for marketed/investigational products. The position also provides and....


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....


Summary: Fast growing division of a global medical device leader is for a Regulatory Affairs lead for new product introduction and support existing products. Requirements:Bachelors degree3-8 years experience with 510(k), CE-Marking and other Regulatory market approval submissions for Class II and III medical devicesGlobal regulatory submission experience highly preferredExperience working new products from initial development through commercializationExperience following trends in regulatory....


Global Pharmaceutical company in Northern New Jersey is expanding and looking for a Snr Clinical Operations Pharmacology Associate for a w-2 long term contract SR. Clinical Operations Associate- Clinical Pharmacology - Serve as operational study lead for assigned Clinical Pharmacology studies, participating in activities during pre-study, start up, conduct phase and close out - Ensure timely execution of studies in accordance with GCP and Allergan’s SOPs. - Assist in development of case report

- Suburban Detroit, MI

Overview: The QA Director is responsible for the overall management of the quality assurance systems and related activities. This includes upholding and improving the quality management system and to promote both the awareness and adherence to customer and regulatory requirements.Top Accountabilities: 1. Ensure that the quality system processes and products comply with Federal and International Regulatory requirements. i.e., (ISO 13485/MDD, CMDR, FDA QSR). 2. Lead the maintenance and....


Accountability Objective: Responsible for the completion of assigned US Regulatory Submission and Compliance activities the company and its designated suppliers; coordinate assigned US and OUS regulatory reporting, such as MDRs, Vigilance Reports, Clinical Progress Reports, and Post-Approval Reports; provide support for: US and OUS regulatory submissions of new and existing products marketed by the company; assure compliance with US and OUS international regulatory requirements for Class III....

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