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I-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Quality Assurance and Bioinformatics. Lead Mechanical Engineer / LME. Lead Mechanical Engineer opportunity to work for a top 10 premier CDMO. This position is working on a recently invested site that will be significantly growing over the next 3 years.
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The Senior Advisor/Director in Global Regulatory Affairs – CMC will leverage CMC technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for clinical trials and marketing authorizations for the synthetic molecule portfolio, including small molecules, peptides, and oligonucleotides.
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Lead Mechanical Engineer opportunity to work for a top 10 premier CDMO. This position is working on a well funded site that will be growing over the next 3 years. Lead Mechanical Engineer - Lyophilizers.
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OR BS degree in health-related or scientific field with 7-10 years of experience in pharmaceutical industry, directly related clinical trial experience or experience in areas relevant to drug discovery or development, e.g. epidemiology, toxicology, pharmacovigilance, regulatory affairs.
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Knowledge of global CMC regulatory requirements and guidelines for conducting clinical trials and obtaining global product registrations. Makes decisions on CMC regulatory strategies impacting product submissions across geographies and networks for alignment with CMC team members.
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Certified Floodplain Manager and/or experience with the Federal Energy Regulatory Commission for Hydropower Licensed Projects a plus. Water Resources Project Manager Flood Control Engineering.
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This position serves as a leader of the Chamber’s legislative affairs, political operations, and grassroots advocacy efforts, as well as a key team member for other advocacy functions such as policy development, events, special projects, and strategic partnerships.
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Stays up to date with knowledge of regulatory affairs and/or issues. Oversees and ensures compliance with regulations, including organizing electronic files and/or filing regulatory documents appropriately; prepares and submits Institutional Review Board (IRB) documents (i.e., Informed Consent, advertisement, protocol and protocol summary); prepares regulatory documents for sponsor.
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Electric Safety Code (NESC,) Federal Energy Regulatory Commission (FERC,) NERC, Occupational Health and Safety Administration (OSHA.) Interface and solicit information and ideas from AES internal stakeholders, including standards, engineering, purchasing, construction, distribution system planning, compliance, regulatory, commissioning, operations, real estate, environmental, document control, asset management, graphical information systems, records, major accounts, and legal.
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Knowledge of Data Historian (OSIPI) Knowledge of Computer System Validation lifecycle and FDA regulatory requirements. PACIV, an international control systems integration, and regulatory compliance engineering firm, servicing Bio-Pharmaceutical, Medical Device, F&B, and Utility clients, is looking for a regular employee-based Senior Automation Engineer team member to join our team based in the USA office (Indianapolis) Job Description : The Sr. Automation Engineer will be twofold.
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This team will be expected to influence and execute regulatory strategies that can accelerate the development of assigned project(s). Partners with Client GRA CMC (regulatory scientists) develop complex regulatory strategies.
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Makes technical decisions on CMC regulatory issues impacting product submissions across geographies, with support or guidance from Client GRCMC regulatory scientists. Proactively identifies and resolves global CMC regulatory issues.
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Communicate frequently with other Respiratory Sales Specialists across the country and cross-functional counterparts such as Marketing, Sales Ops, Market Access, Field Reimbursement, Training, and Medical Affairs to create alignment of business plan, focus on strategic drivers, and sharing best practices.
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This position collaborates directly with the GNBS Program Director, the Indiana Birth Defects and Problems Registry (IBDPR) Program Manager, the Office of Public Affairs (OPA), national organizations, local community health leaders and healthcare providers, both within and outside the state of Indiana.
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Meet weekly with the Residence Life Staff and Student Affairs Suite Staff. Residence Directors should be committed to increasing student engagement and carrying out the mission of the Division of Student Affairs.
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regulatory affairs jobs Title: regulatory affairs project manager Company: Jobget in Indianapolis, IN
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