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Responsibilities: Leads with strong leadership command, for all aspects of quality control and effectively manage employees Participates in all regulatory audits and inspections. Requirements: BS degree in Chemistry, Biochemistry, Molecular Biology, Virology or related scientific disciplines or equivalent experience, + 15 years of experience, 5 years of experience must be in Quality Control or cGMP laboratories.
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Extensive interaction with departments outside of CMC Regulatory Affairs to define strategy and submission plans. An in-depth knowledge of ICH and regional CMC regulatory requirements, and an understanding of current global and regional trends in CMC Regulatory Affairs.
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Experience representing CMC regulatory affairs on regulatory and cross functional teams. Top 3 Required Skill Sets: Significant experience in CMC Regulatory Affairs; strong verbal and written communication skills; experience in leading and preparation of regulatory submissions.
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Liaise with colleagues in Regulatory Affairs therapeutics teams, local Affiliates, Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines.
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Comprehensive knowledge and experience in preparing CMC (Quality) sections for investigational and marketed product submissions (IND, NDA, DMF) for FDA and equivalent submissions for Europe and Canda- Comprehensive understanding of the global regulatory environment.
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High School Diploma/GED from AND ten (10) years of (combined product stewardship, regulatory affairs, or EHS experience in a private, public, government or military environment. Bachelor’s Degree or higher AND three (3) years of combined product stewardship, regulatory affairs, or EHS experience in a private, public, government or military environment.
$145,537 a yearFull-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Forms cross-functional alliances with Small Molecule Drug Substance Development, Small Molecule Drug Product Development, CMC Regulatory Affairs, Quality Control and Manufacturing Operations by providing SMEs to these functions and project teams.
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We are looking for a Quality Control Manager to join our Dallas team! As the Manager, Quality Control, you will have the opportunity to be crossed trained on various aspects of shot peening.
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The Quality Control Tech is a team member who guarantees continuous production and ensures our hot mix asphalt, liquid asphalt, cold mix asphalt, crushed stone, sand, and gravel are consistent with State, Federal and local specifications.
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Collaborate with regulatory affairs and quality assurance teams to ensure compliance with submission guidelines and standards. Perform thorough quality control checks to validate the accuracy and completeness of submission datasets.
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The Wounded Warrior Project (WWP) Government Affairs Deputy Director assists in the development and implementation of WWP’s public policy strategy to advance its legislative, regulatory, and advocacy priorities.
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The Chemist conducts a variety of quantitative and qualitative chemical, microbiological, and physical analyses on drinking water and wastewater in order to meet regulatory, quality control, and process control monitoring requirements.
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Minimum two (2) years in a Regulatory environment within a Customs Brokerage environment. Actively manage and continuously develop a team of compliance professionals providing day to day support of regulatory and compliance-based inquiries.
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This position is involved in a wide-range of analytical development and quality control activities related to clinical products spanning assay development, product characterization, product release assays, stability studies, and support of pre-clinical studies and process development.
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Advanced life science degree or certification in Regulatory Affairs Sciences preferred. Experience and solid knowledge of Pharmacovigilance specificallyProficiency in one or more of these additional areas is a plus: CMC/Mfg., Clinical development and trial execution, Regulatory, Real-World Data and Real-World Evidence, Cell and Gene Therapy, Medical Device, IVD/CDxExperienced in understanding and interpreting regulatory guidelines and documents.
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regulatory affairs quality control jobs Company: Life Science People in Beech-grove, Indiana
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