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Director, Regulatory Affairs CMC. 10+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs / small molecules.
$100 - $113 an hourFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Interact routinely and will develop a strong team environment with colleagues throughout GRSRequirements:Ph. D., M.D., PharmD. , MS or commensurate experienceSignificant experience in regulatory affairs (e.g. 3-5 years)Expert understanding of policy, laws, regulations and guidelines as they apply to U.S. FDA for drug development and approval.
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Serves as University Ambassador for special programs sponsored by the Chancellor's Office, Academic Affairs, Advancement, Student Affairs, University and Community Relations, Business Affairs, Athletics, and other areas, as requested.
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Work with CMC cross-functional teams and Regulatory Affairs teams. BS/BA degree in Scientific Discipline (master's or higher preferred) with 5+ years in the pharmaceutical industry, preferably with 3+ years CMC regulatory experience.
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QUALIFICATIONSA scientific degree with directly relevant professional experience in small molecule development, global CMC regulatory affairs and CMC technical areas of at least 16 years with a BA/BS or 14 years with an MA/MS, PhD, PharmD, or MD. Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc.
$295,290 - $382,140ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Familiarity with DoS environment (data and voice networks, IT security systems, policies and procedures), Foreign Affairs Handbooks (FAHs), Foreign Affairs Manuals (FAMs). Program is named "Vanguard" and is an IT consolidation consisting of the Department's servers, mainframes, network devices, network perimeter, anti-virus engineering, public key infrastructure (PKI)/biometrics/encryption, monitoring tools, telephony, mobile computing platform, virtual environment, and enclave design/security engineering.
Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Business Affairs consists of 5 divisions reporting to the Associate Vice President for Business Affairs/Controller and provides direct services to staff, students, and UO departments: Financial Services/Accounts Payable/Travel, Student Financial Services, Payroll, BA Information Systems, and Treasury Operations.
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We are looking for a Director of Regulatory Reporting, a leadership position within the team that is responsible for ensuring the overall integrity of trade and position reporting submitted to the regulators for the Fidelity Broker-Dealers, National Financial and Fidelity Brokerage Services, as well as for correspondent client broker-dealer firms.
$85,000 - $144,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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We are seeking a(an) Director of Regulatory Compliance with Riverside Community Hospital to promote growth and unlock possibilities. The Director of Regulatory Compliance and Accreditation is responsible for administration and oversight of all activities concerning the achievement of continuous regulatory and accreditation readiness, quality excellence, and corporate safety compliance for the organization.
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As an integral member of Pharmacy Services, the IDS/Pharmacy Regulatory Coordinator's role also includes assuring accurate record keeping, filling, compounding and delivering of investigational drug products to study coordinators, study nurses and patients.
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U00A0We are looking for a Director of Regulatory Reporting, a leadership position within the team that is responsible for ensuring the overall integrity of trade and position reporting submitted to the regulators for the Fidelity Broker-Dealers, National Financial and Fidelity Brokerage Services, as well as for correspondent client broker-dealer firms.
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Collaborate with onshore teams and stakeholders to gather business requirements related to QMS functionalities, with a focus on Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions.
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This position will partner with Regulatory Affairs as the department brings publishing and submissions in-house. The Senior Manager/Manager Regulatory Document Submissions will report to the Director of Medical Writing, Regulatory.
$126,500 - $160,100 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Key Responsibilities The Medical Science Liaison (MSL) is a member of a field-based team of scientists who function as an extension of the US Medical Affairs organization. MSLs provide medical information through scientific exchange in a fair-balanced manner and provide clinical/scientific support for Bristol Myers Squibb and the Medical Affairs department at the direction of Medical Affairs management.
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Position ResponsibilitiesThe Associate Director, Regulatory Affairs will develop and implement the regulatory strategy for an upcoming BLA submission, in alignment with company goals and FDA requirements.
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regulatory affairs jobs Title: sr director Company: Thermo Fisher Scientific
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