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As part of the GRA CMC Pharmaceuticals, Oligonucleotides team, you will report to the Executive Director and Head, CMC Regulatory Affairs, Pharmaceuticals. Join Takeda as a Director, GRA CMC Pharmaceuticals, Oligonucleotides where you will lead the GRA CMC Pharmaceuticals Oligonucleotide regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM stages.
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As part of the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. Join Takeda as a Senior Director, GRA Pharmaceuticals- Small Molecule where you will establish collaboration with Global CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives.
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The CRU Regulatory Affairs Office seeks a full-time Regulatory Affairs Veeva Quality Assurance Specialist to participate in the review and migration of Phase I-V clinical trial investigator site files to the Veeva SiteVault platform.
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3) Work with Regulatory Affairs Specialist to prepare for audits, review regulatory binders, perform internal audit and other QA activities, and handle monitor/audit visits with CROs, the FDA and other entities.
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Bachelor's degree required, with over three years of pharmaceutical/biotech industry experience, including two years in regulatory affairs or operations. Piper Companies is currently seeking a Sr. Regulatory Operations Specialist to support a growing and innovative cell and gene therapy company in Philadelphia, PA (Hybrid Schedule.
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Must be a law school graduate with an LLB or JD degree Must be admitted to the Pennsylvania Bar.5 or more years of experience working with laws and regulations related to litigation, commercial, energy, and/or regulatory law.
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The Quality Manager is also responsible for clinical privilege development and management of the TUHS Medical Staff Affairs Department, internal Credentialing Verification Organization (CVO) which oversees the credentialing of TUHS physicians and APPs working in non-licensed TUHS facilities.
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The Regulatory Law Unit's Airport Division is seeking a licensed Pennsylvania Attorney to fill an Assistant City Solicitor or Deputy City Solicitor position. The attorney will work on a wide range of transactional and compliance matters handled by the Airports Division, including negotiating and drafting of contracts and advising the airport staff on legal and regulatory matters, as necessary, for the City to operate and develop its two airports.
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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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Develops/Reviews Stormwater Management Reports and Stormwater Pollution Prevention Plans (SWPPP) to support regulatory permits; Conversant with regulatory codes, design codes and standards, best management practices, permit requirements and construction practices.
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Communicate with class, USCG, FDA and any other required regulatory agency to resolve any regulatory or inspection issues raised during construction of the vessel. Maintain working knowledge and monitor development of classification and regulatory rules and requirements.
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Responsible for overseeing implementation of the company’s food safety and quality management system to assure food product integrity and compliance with specifications, SQF, GMP's, HACCP, USDA regulatory and customer standards.
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This role will be as part of a global team supporting ESG and Government Affairs required and voluntary disclosures as well as supporting the office of the CSO as needed with sustainability data analytics and management and researching new and upcoming sustainability related grant opportunities and regulations.
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Ensures that all regulatory requirements are met including Joint Commission and all Commonwealth of Pennsylvania statutes. With more than 11,000 team members, Tower Health includes Reading Hospital, a teaching hospital based in West Reading; Brandywine Hospital in Coatesville; Chestnut Hill Hospital, a teaching hospital in Philadelphia; Jennersville Hospital in West Grove; Phoenixville Hospital in Phoenixville; Pottstown Hospital in Pottstown; and St. Christopher's Hospital for Children.
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Experience working with regulatory approvals, including working with planning & zoning compliance. Ensure regulatory approval; this includes having an understanding of (and working with) planning & zoning compliance.
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regulatory affairs jobs Title: sr director Company: Merck in Philadelphia, PA
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