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Within Global Regulatory Affairs, our Chemistry, Manufacturing and Controls (CMC) organization provides regulatory leadership to CMC development teams and the Pharma Supply Chain organization to enable approval of new medicines and uninterrupted supply of our medicines to patients.
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We are seeking a talented and highly motivated Sr. Associate Scientist in molecular biology and metabolism to support our drug discovery programs. Experience with molecular biology techniques such as DNA and RNA extraction, qPCR, protein quantification, ELISA, and enzymatic assays is required.
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A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 15 years with a BA/BS, MA/MS, PhD or PharmD. Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development.
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2-5 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry, with a focus on regulatory operations. As the Regulatory Affairs Operations Specialist, Ad/Promo, you will play a pivotal role in ensuring regulatory compliance and operational efficiency within our organization.
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Over 15 years of progressive advancement within global regulatory affairs in the pharmaceutical /biotech industry. The Vice President, Regulatory Affairs & Quality is in charge of providing subject matter expertise on all matters related to FDA and global regulatory requirements, as well as leading the growth and responsibilities of the regulatory and quality department.
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Sr. Data Engineer focus: In- Depth knowledge of data warehousing, Hadoop, data lakes, data analytics, data management, data governance and/or BI. In- Depth understanding of cloud analytics/Data service offering, Cloud architecture and economics.
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Dragonfly Therapeutics is seeking a Senior Director, reporting directly to the Senior Vice President, Head of Regulatory Affairs, to join the regulatory team within our Regulatory Affairs organization.
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The Director of Medical Affairs at Thermo Fisher Scientific will play a pivotal role in both strategically and functionally leading the North American (NA) Medical Affairs Team, undertaking the initiatives supporting the Clinical Sequencing Division (CSD) activities.
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Research Associate/Sr. Research Associate, Oligonucleotides 2026401. Job Overview: We are seeking a Research Associate/Associate Scientist to join our clients Oligonucleotide team, where you will play a pivotal role in the development of a cutting-edge drug delivery platform and clinical program pipeline by contributing to the synthesis, purification, and characterization of oligonucleotides, providing you with an exciting opportunity to make a meaningful impact.
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Knowledge and work experience related to energy and climate policy, and familiarity with utility regulatory practices and issues, renewable or clean energy standards, distributed energy resources, performance-based regulation, and emerging technologies such as renewable natural gas, hydrogen, and energy storage.
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The Associate Director of Regulatory Operations is responsible for the assembly, publishing, and submission of regulatory filings to global Health Authorities (HA) in an efficient and timely manner.
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Attains and can demonstrate fundamental knowledge and is somewhat proficient in some or all of the following areas: DFCI, DF/HCC, ICH/GCP, FDA policy / guidance / regulation; an understanding of the IRB submission & approval process; Regulatory Binder maintenance; PI Initiated / Multi-Center Trials; protocol and consent design and development and FDA IND and other regulatory required submissions.
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Familiarity with relevant regulatory requirements of the life science industry such as cGMP, 21 CFR Part 11, etc. On-Board Companies is hiring for a Sr. Controls Engineer / Project Lead in Wilmington, MA.
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Fitness Instructor - Group Exercise Classes in Senior Living Community!
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Reporting to the Associate Director, Drug Safety and Pharmacovigilance Compliance and Operations, you will play a pivotal role in drug safety activities, supporting records management and compliance across the clinical development and marketing programs.
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Title: sr regulatory affairs associate in Lexington, MA
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