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QualificationsTo be considered for this role, you’ll require a minimum of 5 years of professional experience in relevant field of healthcare products or related activities e.g.:Work in medical devices industry and/or in vitro diagnostic devices(preferred) or closely related industries (e.g., pharmaceutical industry) such as research and development, manufacturing, quality management, regulatory affairs.
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Ensure technical project execution in hazardous waste management, air emissions permitting, wastewater/stormwater permitting, industrial safety, industrial hygiene, and other regulatory program areas.
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Knowledge of Sustainable Finance / ESG Risk / CSRD / Regulatory Reporting, cloud infrastructure and data governance best practices, and terraform will be a plus. Knowledge of Sustainable Finance / ESG Risk / CSRD / Regulatory Reporting, cloud infrastructure and data governance best practices, and terraform will be a plus.
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Keywords: Chemistry, Chemical Engineering, small molecule, pharmaceutical manufacturing, process chemistry, late stage, process development, GMP, quality, Director, AD, Assistant Director, quality, regulatory, genetic diseases, QC, pharma, CDMO, Contract Development Manufacturing Organization, CMC, drug substance.
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Implement and coordinate assigned clinical trials including start up, vendor management, subject recruitment, source development review, scheduling subjects, protocol training, collection of regulatory documents, conducting and participating in the ICF process(es), ensuring data is entered in a timely manner and all queries are resolved, managing and reporting adverse events, serious adverse events, and deviations, implementing new protocol amendments, providing all close outreports.
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This position requires a deep understanding of pharmaceutical manufacturing principles, process engineering, and regulatory compliance. Knowledge of regulatory requirements and quality systems in the pharmaceutical industry.
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The division serves all students at NC State through three integrated components: academic affairs, student affairs, and University College. Job Location Raleigh, NC Department Campus Health Services About the Department The Division of Academic & Student Affairs (DASA) is where students discover connections and community.
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Medical Affairs: This role is focused heavily on establishing and maintaining external professional relationships and engaging in scientific exchange with health care professional (HCPs), Key Opinion Leaders (KOLs), payers, and clinical investigators in the through the MSL team.
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Working knowledge of OSHA, NFPA, ANSI, ACGIH, ASME and other health and safety related regulatory and consensus standards. The EHS Specialist supports the EHS goals and functions of the pharmaceutical manufacturing facility.
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Ensure compliance with regulatory requirements and industry standards related to cryptography and data security. Experience with Hardware Security Modules (HSMs), preferably with Thales CipherTrust Manager (CTM) of HSM and KMS products.
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Preferred Qualifications Experience working with legal counsel on regulatory and legislative affairs. The Virtual Power Plant Policy Director will lead SUN’s policy, regulatory, and advocacy efforts to implement solar + batteries Virtual Power Plant (VPP) policy across the country and in targeted states.
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MedPro is one of the largest recruiters of therapists and nurses from outside the U.S. MedPro currently has contracts with numerous organizations to service a multitude of facilities in the U.S. The company counts among its clients prominent healthcare facilities and organizations such as the Department of Veterans Affairs,HCA, University of Miami Hospital, and Tenet Healthcare.
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Projects may include, but are not limited to, master planning, hydraulic modeling, water and wastewater treatment, water distribution systems, wastewater collection systems, pump stations, storage tanks, groundwater systems, asset management, utility management, regulatory compliance, and funding assistance.
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Strong understanding of cryptography, Key Management Systems (KMS), and Public Key Infrastructure (PKI) Provide expertise on network security protocols such as SSH, SSL/TLS, and SCP/SFTP. Familiarity with Public Key Cryptographic Standards and network security protocols (SSH, SSL/TLS, SCP/SFTP.
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Preferred SkillsAnalytical Thinking, Commercial Real Estate, Competitive Advantages, Consumer Lending, Credit Risk Management, Data Analytics, Decision Making, Financial Operations, Portfolio Risk, Risk AppetiteCompetenciesAnalytical Thinking, Conflict Management, Credit Risk, Effective Communications, Loan Review, Organizational Governance, Regulatory Environment - Financial ServicesWork ExperienceRoles at this level typically require a university / college degree.
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regulatory affairs jobs Title: affairs Company: Jobget in Cary, NC
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