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Acts as equipment commissioning and qualification SME in internal and regulatory audits. 4) Regulatory Responsibilities: a. PREFERRED: Commissioning and qualification of liquid nitrogen supply systems, DI Water, autoclaves, isolators, filling and capping equipment, and airflow visualization studies.
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Cell/Gene Therapy and CDMO experience preferred Work effectively with US FDA and other regulatory agencies. Position Summary We are seeking a highly motivated Vice President of Operations who will be responsible for the launch, ramp-up, and oversight of cGMP Operations within a state-of-the-art multi-product cell therapy manufacturing facility that will be utilized to manufacture autologous and allogeneic cell therapy products.
$200,000 - $300,000 a yearExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Education equivalent to a PhD or MD degree or equivalent in a scientific field or experience in lieu of, plus at least 4 years' experience in Regulatory Affairs; or. Education equivalent to a BS degree or equivalent in a scientific field or experience in lieu of, plus at least 8 years' experience in Regulatory Affairs.
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Regulatory Responsibilities: a. Intermediate knowledge of pharmaceutical manufacturing and utilities that support cell therapy clinical manufacturing. Thorough knowledge and hands-on experience with airflow visualization (smoke studies.
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Technical knowledge in metrology, calibrations, instrumentation, automation PLCs, VFDs and electrical practices generally attained through hands-on experience, cGMP compliance, EHS and regulatory standards (e.g. EPA, OSHA and DEA.
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EHS and regulatory standards (e.g. EPA, OSHA and DEA). Partner and manage relationships with contractors to ensure quality of work and compliance with all company policies and regulatory guidelines.
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Bachelor's degree or equivalent experience in Engineering, Public Administration, Business, Marketing or International Affairs. These activities are focused on leveraging technology for sustainable development and disaster response across IEEE to infuse best practices, enhance collaboration and create an umbrella for partnerships for scale.
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Prepares medical considerations sections for proposals Supports or participates in bid defense meetings Meets with clients as needed Write or edit scientific content of deliverables within budget timelines Collaborates with Regulatory Affairs on regulatory product landscape and strategies as a part of overall drug development strategy.
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The individual must engage with other departments including Quality, Regulatory Affairs, Sales, Manufacturing Operations, and Purchasing, to ensure procedures and specifications are set properly and can be met consistently.
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Issue designs and support them through the project lifecycle including: design, drawing reviews, electromagnetic emissions analysis, and regulatory submissions (FCC and EME). Interface with project managers, real estate, construction, field operations, engineering, sales, marketing, finance and regulatory to ensure that our network quality and financial objectives are met.
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PREFERRED QUALIFICATIONS:Education: Advanced Healthcare Degree (preferred PharmD or equivalent), Masters in Business Administration or Regulatory Science. In particular, detailed knowledge and understanding of the regulatory and compliance environment as it relates to the medical communications contact center.
$165,000 - $200,000Full-timeRemoteExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Knowledge and experience of applicable FDA regulatory standards and requirements for the solid oral dosage manufacturing required. Maintains knowledge of the latest guidelines of regulatory requirements of International Conference of Harmonization, USP, USFDA and OSHA. Complies with all regulatory/ inhouse requirements may include but not be limited to safety, housekeeping, laboratory chemical waste, cGMP, cGLP, documentation.
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License to practice Speech Language Pathology issued by PA Bureau of Professional and Occupational Affairs is preferred. Will consider strong Clinical Fellowship Year (CFY) candidate for Long Term Substitute (LTS) positions in the Related Services program.
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Provide support and leadership to Product Development/R&D, Quality, Regulatory, Operations, Sales & Marketing on all product lifecycle issues, including new product introduction, design changes and product end-of-life issues.
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Qualifications: Bachelor’s degree in chemistry or related scientific field and + years’ industry experience as a Chemist or master’s degree in chemistry or related scientific field and + years’ industry experience as a Chemist Knowledge of current GMP guidance, applicable USFDA and ICH guidelines and regulatory requirements (such as USP/ICH requirements) Ability to make observations with instruments and analysis techniques.
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regulatory affairs jobs Title: sr regulatory affairs associate in Bridgewater, NJ
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