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Chiesi USA is a specialty pharmaceutical company focused on developing and promoting products for the hospital, adjacent specialty and rare disease markets. Lead the development and implementation of Chiesi Global Rare Disease procedures for the regulatory aspects of labeling preparation, launch prep, review, approval, and submission.
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Regulatory Affairs, Labeling Experience Experience in Labeling: Proven experience in the development and review of labeling for pharmaceutical and biotech products. Knowledge of Labeling Regulations: Familiarity with FDA and international regulations related to pharmaceutical and biotech product labeling.
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Tasks to be completed may include fermentation, protein purification, solvent extractions, tissue culture, preparation of bulk solutions, aseptic fills of buffers, filling and labeling of vials under sterile and non-sterile conditions, routine buffer and media preparation, filtration, vial preparation and sterilization.
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Technical Expertise 4.1 Demonstrate proficiency and mastery of various technology utilized in the provision of pharmaceutical care, including, but not limited to: EMR, ADS, Inventory Management software, carousel, Packaging software, Sterile Product Pharmacy Workflow Manager, Barcode Labeling Programs, RFID Technology (usage varies depending upon hospital.
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Regulatory Affairs, Chemistry, Manufacturing, and Controls (CMC) ExperienceExperience in CMC: Proven experience in the development and review of CMC regulatory documents for pharmaceutical and/or biotech products.
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This role requires an understanding of pharmaceutical labeling and packaging operations, logistics, supply chain as well as financial and project management skills. The Manager, Packaging Operations & Supply Chain will be the person-in-plant supporting CMO-lead finished goods labeling, packaging, and logistics operations management in Philadelphia, PA for a new class of clinical and commercial Gene Therapy products.
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The Director, Product Quality also works collaboratively with Technical Operations for Drug Substance/Drug Product/Bottling/Labeling for conformance with cGMPs, Quality Control to assess laboratory conformance with cGMPs, and with CMC Regulatory Affairs to ensure the translational accuracy and integrity of data incorporated into Module 3 sections of CTD regulatory submissions and written responses to regulatory authorities.
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12+ years’ experience in at global pharmaceutical or biotechnology companies, including 10+ years’ experience as a safety physician leading SMT in drug safety & pharmacovigilance for products in clinical trial and post-marketing environments.
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Community/retail pharmacy technician experience or academic training /experience in health related fields (Laboratory Sciences or Pharmaceutical Sciences) also considered. 1.5 Demonstrate reliability in providing assistance to the pharmacist in regards to the provision of pharmaceutical care.
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Performs highly complex (senior level) pharmaceutical tasks and inventory control work by assisting in drug picking and packing, drug repackaging, drug labeling, and quality control and quality assurance functions under the direct supervision of a Registered Pharmacist and in coordination with Pharmacy Branch personnel.
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Excellent understanding of US regulations for drug promotion/advertising and US labeling, and experience interacting with FDA OPDP• Experience with Veeva Vault PromoMats and MedComms, Trackwise, or similar document management systems a plus• Demonstrated expertise in regulatory requirements for labeling and advertising materials.
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Our Specialty Additives product line provides mineral-based technologies serving Paper, Packaging, Sealants & Adhesives, Paint & Coatings, Ceramics, Plastics, Food & Pharmaceutical markets. The Quality Assurance (QA) Manager is responsible for the planning, execution, and overall management of an FDA and GMP regulated Quality Unit which governs the site's manufacturing, packaging, labeling, testing, and holding activities of goods produced.
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Terminal degree (DVM, PhD, MD) in pharmaceutical, biological, or chemical sciences. We aim to begin generating IND- and IDE-enabling data for novel cell, gene, and oncolytic therapies that oftentimes require co-labeling with drug delivery devices.
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We are hiring for a QA Director to join a nonclinical CRO working with both small and large animal models while working collaboratively with groups that span biotechnology research. This role is expected to act as a thought partner, working with other leadership members to assure that operations in all departments run smoothly and maintain compliance with relevant regulations, including those originating from the FDA, the USDA, the NIH, or other regulatory bodies.
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Communicate effectively and transparently with functional heads within pharmaceutical development and other company stakeholders (Quality, Toxicology/DMPK, Clinical/Regulatory, Operations, Project, etc.
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labeling pharmaceutical jobs
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