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15+ 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.
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Financial Risk Manager (FRM)/Certified Financial Analyst (CFA) or equivalent advanced risk certificationUnderstanding and familiarity with key processes associated within [Consumer and Small Business Banking, Enterprise Operational Services, Enterprise Technology, Finance, Government Affairs and Legal Team, Human Resources, Risk Management Organization, Wholesale] line of business / corporate function.
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A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 20 years with a BA/BS, MA/MS, PhD or PharmD. 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.
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Specific responsibilities include Quality Systems, FSMA, HACCP, GFSI/BRC, regulatory audits, food safety training, Regulatory Affairs, Plant Quality Assurance, Vendor Compliance, and Consumer Affairs.
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What we look for: A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 20 years with a BA/BS, MA/MS, PhD or PharmD.Demonstrated organizational leadership skills at both functional and enterprise levels.
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Our work depends on Regulatory Affairs Manager joining our team to contribute to PKI and Identity Management policy development, technical liaison and advisor. Seize your opportunity to make a personal impact as a Regulatory Affairs Manager supporting a PKI Government High Value Asset Mission Essential Function program.
$155,934 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Washington DC, Department of Consumer and Regulatory Affairs, Board of Industrial Trades, Class 1 – Steam Engineer License MD, Class 1 – Steam Engineer License. Ten (10) years’ experience as a mechanical engineer or journeyman mechanic with field experience in either maritime or industrial plant (construction, operation, or maintenance) as well as one of the following licenses: National Institute for the Uniform Licensing of Power Engineers, Inc. (NIULPE) First Class Power Engineer License.
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Balance reporting requirements to multiple constituencies including; Centene Corporation regional vice president, state health plan president, chief operating officers and Corporate regulatory and government affairs staff.
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Bachelor of Science, International Affairs/Foreign Affairs or similar field with 4+ years of relevant experience OR a Master of Science, International Affairs or similar field with 2+ years of relevant experience.
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Position SummaryThis position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients.
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In collaboration with the Clinical Affairs Lead and Medical/Scientific Lead, prepares strategy decisions, presents, and discusses data at relevant team, governance, external consultants, KOL and potentially regulatory meetings.
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The Project Manager, CMC Regulatory Affairs will be responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products.
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The Vice President for Fiscal Affairs & Chief Financial Officer (CFO) serves as a key advisor and thought partner to the university President. The Vice President for Fiscal Affairs & Chief Financial Officer (CFO) is responsible for providing leadership, oversight, strategic planning, and direction for all fiscal affairs for Commonwealth University of Pennsylvania, inclusive of the Bloomsburg, Lock Haven, and Mansfield campus locations.
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ADARs will also be required to coordinate and communicate cross-functionally within NPC (e.g., Patient Support Center, Customer Engagement, Marketing, Market Access, Public Affairs, State & Government Affairs, Trade, Specialty Pharmacy Account Management, and other applicable third-party affiliates.
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Represents Clinical Affairs line in program-wide functions on Clinical Project Team, Medical Sub Committee, Clinical Study Teams, Asset Team, Program Teams, and Regulatory Strategy teams as applicable.
$269,400 a yearFull-timeExpandApply NowActive JobUpdated Today
consumer affairs jobs Title: regulatory affairs Company: Vaco in Anoka, Minnesota
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