Mgr reg affairs jobs in the Biotech, R&D, Science category

International company has an outstanding opportunity in the Washington DC area for a: Senior Manager of Regulatory Affairs · Will provide regulatory advice and facilitate regulatory strategy development and implementation · Will help prepare for meetings, teleconferences, and other communications with FDA · Will apply regulations and guidelines to the product development process. · Will lead prepa...
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Senior Manager - Regulatory Affairs Brand Products – Global Pharmaceutical Company US headquarters: Princeton, NJ Resumes to: Nancyc@directhr.com · Demonstrate ability in analytical reasoning and critical thinking · Actively participate in weekly conferences to discuss regulatory filing strategies and timeline · Knowledge of pharmaceutical brand industry · Maintain a filing grid for all branded pr...
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Director / Senior Manager Regulatory Affairs Post Marketing Basic Responsibilities: · Represent Regulatory Affairs on Promotional Review Committee · Act as the primary point of contact with OPDP · Handle BLA/NDA post approval FDA responsibilities · Oversee Clinical from a Quality perspective Job Requirements: Knowledge and Skills Required: · Minimum 5 years of regulatory affairs post marketing exp...
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Pulmonx Corporation, based in Redwood City, CA, is focused on developing and marketing minimally invasive medical devices and technologies for the diagnosis and treatment of pulmonary disorders. For its Redwood City location it is seeking a Regulatory Affairs, Manager Responsibilities and Capabilities: Plan, coordinate and prepare documents packages for regulatory submissions, including FDA 510(k)...
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Responsibilities (brief statement indicating the main focus of this position): The Regulatory Manager performs regulatory compliance work including overseeing filings, reporting, recordkeeping, inspections, surveys, assessments, or investigations to ensure compliance with regulations,laws, permits, and other site requirements. Incumbent responds to requests from customers and authorities. Addition...
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SUMMARY Manage Stila’s regulatory process by maintaining current regulatory knowledge of domestic and international regulations, guidelines and standards. Oversee applying appropriate implementation strategies. Prepare and maintain global regulatory submissions, registrations and licenses. Additionally, responsible for the quality assurance of all finished goods. Interface with internal department...
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Job Description – Clinical Manager, Scientific Affairs and Clinical Assessment LOCATION: Philadelphia Area SUPERVISOR: Director, Scientific Affairs and Clinical Assessment SUMMARY: TheClinical Manageris responsible for all aspects of assigned projects that include clinical assessment, training development and certification for Worldwide Clinical Trials, Inc. (WCT). The Clinical Managerworks under ...
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Sr. Manager of Medical Communications -To watch a video about this opening,Click Here! -To watch a video about our firm,Click Here! A small Biopharma with three products in development is expanding in Medical Affairs department. They are looking for an Sr. Manager of Medical Communications following a very successful Hematology/Oncology product launch. This East Coast organization is very dynamic ...
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Manager, Drug Safety – Gaithersburg, MD The Manager of Drug Safety is responsible for the day to day management of drug safety surveillance processes to ensure company compliance with regulatory requirements. The position requires strong familiarity with FDA and ICH regulations, and hands on experience with both the clinical and post-marketing aspects of drug safety, as well as report writing skil...
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Senior Manager, Clinical Project Lead Reports to: Head of Clinical Operations Location: Cheshire, CT Alexion Pharmaceuticals, Inc. is a biopharmaceutical company focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products. Alexion is the global leader in complement inhibition, and has developed...
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Leadership – Bio-pharmaceutical Title open: Manager, Sr. Manager - pending experience This role will report to the Vice President of Analytical and Technical Services Key Responsibilities Supervise, train, and assign training for a group of chemists, scientists, and/or technicians Provide scientific leadership in analytical sciences Design, validate, and conduct new procedures, systems, and techni...
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The Global Clinical Immunology (GCI) Project Representative manages the interactions between GCI and internal/external customers while ensuring relevant department deliverables are met. The Project Representative provides clinical immunology expertise to Project or Clinical Teams and ensures resource availability within GCI to meet specific project testing needs, taking into account overall projec...
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Johnson & Johnson companies are equal opportunity employers. Clinical Research Manager-8441130115 Description Vistakon, a member of the Johnson & Johnson Family of Companies is recruiting for a Clinical Research Manager located in Jacksonville, FL. VISTAKON®, a division of Johnson & Johnson Vision Care, is a worldwide company with operations in the United States, Japan, Latin America, Asia-Pacific...
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Class I manufacturer is seeking a Product Development Engineering Manager who will be part of the Executive team and who will be responsible for all aspects related to the research and design of mechanical and electromechanical products and systems. Will direct and coordinate activities involved in design, fabrication, operation, application and installation of products and systems. The Manager wi...
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We have an urgent need for Clinical Project Manager (Non-MD) - C with Pharmaceutical Client. If you or any one you know is interested in this opportunity, kindly respond back ASAP with your updated resume and the details mentioned below. We will be glad to represent your resume to our client and help you in your job search. Job Title: - Clinical Project Manager (Non-MD) - C // ABLJP00043022 Locati...
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Title: GxP QA Manager South San Francisco, CA A growing biopharmaceutical company is hiring a GxP QA manager to lead audits in South San Francisco, CA. If you are looking for a position to lead auditing and the development of a pharmaceutical auditing program keep reading! With current partnerships on commercial drugs with the world’s largest pharmaceutical companies alongside a portfolio of in ho...
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The Clinical Project Manager is responsible for independently managing multiple clinical trials of moderate complexity or managing a broader range of activities on large multi-center studies. The Clinical Project Manager is expected to address site and vendor related issues, with assistance as needed. Specific responsibilities include the clinical trial management of timelines, budgets, resources,...
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Vice President, Quality; NJ Biotech; Retained Search The Vice President, Quality is responsible for all Quality functions, including Quality Assurance, Quality Control, Analytical Services, Quality Compliance, and Validation at both the corporate and Manufacturing sites and oversee a team of 200+. Quality Assurance defines, implements, and manages the various quality programs needed to ensure comp...
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Celerion is the premier provider of innovative early clinical research solutions and is searching for a full-time Manager, Medical Writing. This is a working manager position that provides management and staffing responsibilities including: Provide management, leadership, and mentoring to direct reports; Oversee day-to-day operations of medical writing services by assigning and directing work, pro...
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IMC is looking for a Project Manager with Bioinformatics experience to support work that our company is doing in Bethesda, MD. 8+ years project management experience, Excellent leadership skills; a team player; a creative and strong conceptual thinker; high energy; exhibit excellent writing, communication and presentation skills; detail oriented; and be well organized. A technology, consulting or ...
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AVANZA is the premier GLP laboratory located in the Maryland biotechnology corridor. Our expertise in Drug Development Services spans general toxicology: small/large molecules, vaccines, experimental medicine/efficacy models. Our BioPharmaceutical Services support the development of biologics and vaccines. Our testing capabilities include PK, immunogenicity, cell-based bioassays and biomarkers. We...
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AVANZA is the premier GLP laboratory located in the Maryland biotechnology corridor. Our expertise in Drug Development Services spans general toxicology: small/large molecules, vaccines, experimental medicine/efficacy models. Our BioPharmaceutical Services support the development of biologics and vaccines. Our testing capabilities include PK, immunogenicity, cell-based bioassays and biomarkers. We...
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Job Title: Job ID: 13815 Location: Berkeley Heights, NJ Offsite Territory: Full/Part Time: Full-Time Regular/Temporary: Regular Category: Information Technology Department: IT - Global Business Partner - 4168 Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than...
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Embedded Software R/D Manager - 1300337 Description Itron is offering a career opportunity to the right individual who has progressively made their mark in embedded software development arena and is in the process of taking their career to the next level.an R&D Embedded Engineer Manager. This is an opportunity to join a group where embedded design and development plays an integral role in the comp...
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Environmental Project Manager Insurance Restoration Specialists, Inc. (IRS) is a turnkey environmental company seeking a Project Manager licensed with the NJDEP for Subsurface Evaluation & Tank Closure. Candidate will complete a wide array of tasks for each project from cradle to grave. Everyday tasks may include site inspections, job estimation providing cost estimates and proposals, supervising ...
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