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The Regulatory Affairs Associate is responsible for assessing and ensuring regulatory compliance of the quality management system. We are looking for a Regulatory Affairs Associate to join our company full time in Conshohocken, PA. This position requires the incoming candidate to be onsite, 5 days per week at our office in Conshohocken.
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The AD partners with other functional leaders in CMC, Regulatory Affairs, Clinical Operation and Quality Assurance in support of the study project teams and ensures timely drug supply for clinical trials.
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At least 3 years of quality and/or regulatory experience in an FDA regulated environment for HCT/Ps and/or medical devices (or related field) Support development of validation protocols to verify compliance with regulatory requirements.
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O Provides communications between Global Regulatory Affairs CMC and partners within GRA and across and outside of the organization, as evidenced by the successful achievement of CMC regulatory milestones according to project plans, and by the level of partner satisfaction with the support provided by the group.
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Fosters effective cross functional relationships including but not limited to Marketing, Medical Affairs, Regulatory Affairs, Legal, Compliance and Sales. 7-10 years professional experience Experience working with patient advocates, advocacy organizations in rare disease categories Knowledge of relevant legal, compliance and regulatory requirements to engaging with patients Direct line management experience preferred Consumer marketing experience a plus.
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Establishes and gains approval for strategic direction and marketing activities associated with multiple product portfolios, including product and LCM launches that span numerous the COAG Franchise including gene therapy and ensures active inputs from key stakeholders in medical affairs, sales, commercial development, clinical research and development, regulatory affairs, etc.
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Internal stakeholders include Brand Marketing, Commercial Development, Regulatory, Sales, Corporate Accounts, Sales Training, Field Reimbursement Support, Pricing, Contracting, Patient Services, Government Affairs, and HEOR. Ensures that field-based professionals (Corporate Account Managers, Sales Representatives) are aligned with HCS-led initiatives.
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Reporting to the Director in Regulatory Chemistry, Manufacturing & Controls (CMC), the Senior Scientist is responsible for implementing Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for assigned products in accordance with global regulations, guidance's, and defined regulatory strategies.
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Effectively collaborate to ensure alignment and success with cross-functional partners including Market Research, Analytics, Corporate Affairs, Patient Services, Medical Affairs, Regulatory, Legal, Compliance, Market Access, etc.
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Only QUALIFIED Healthcare Professionals accepted) Hospital/Clinic - Quality Medical Manger (QMM) - Senior Regulatory Affairs Associate Conshohocken, PA. The Senior Regulatory Affairs Associate is responsible for assessing and ensuring regulatory compliance of the quality management system.
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As a member of RDRC and Organon Safety Review Committee (SRC, chaired by the Chief Safety Officer), the R&D Compliance Council, the Medical Affairs Review Committee, and the Recall Committee, ensure comprehensive assessment of benefit-risk, appropriate actions in line with scientific, medical, regulatory and legal guidance for all Organon product candidates and marketed products.
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The Global Supply Chain & Technical Operations summer intern will be exposed to a broad spectrum of activities across our enterprise function, including New Product Introductions, Demand & Supply Planning, Inventory Management, Third-Party Contract Manufacturing, Quality Assurance, Regulatory Affairs, Digital Tools and Business Process Management.
$22 - $45 an hourInternExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Continuing education or certificates in project management, six-sigma, statistics, engineering, quality, or regulatory affairs is desirable but not required. Participate in regulatory body inspections or remediation efforts under direction from senior resources.
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Collaborate with internal stakeholders including Regulatory Affairs, Clinical Development, and Legal. In this role you will be responsible for supporting the Medical Affairs Operations function through vendor management, budgeting, and project management for the department based on the Medical Affairs strategy.
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The Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) submissions, and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III products.
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regulatory affairs jobs in Wayne, PA
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