- Insmed Incorporated (San Diego, CA)
- …multiple phases of clinical research (Phase 1-3)Knowledge of ICH-GCP and FDA regulatory guidelinesDomestic and/or International travel required 20%Travel ... & interpretation of clinical trial data, authoring clinical study and regulatory communications and documents, and monitoring of competitor activities and data.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …DSUR, IND/NDA/BLA annual reports, BTD request etc.).Develop less complex Module 1 regulatory documents (eg cover letter, FDA forms, administrative information, ... letter of authorization, etc.) for US regulatory submissions.Support FDA meeting preparation including preparation of briefing document, meeting request,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or More Years pharmaceutical or biotech industry experience, particularly in contracting and FDA regulatory issues preferred- 1 or More Years prior experience on ... to this position will perform research and advise clients on legal, business and regulatory issues. This position will primarily support the US R&D functions and may… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education ... reports directly to the Vice President, CMR Strategic Operations. External relationships include regulatory authorities: FDA and Health Canada AE and MDR and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...product and establishment registrations (drug/establishment listings) and submission to FDA databases. This individual acts as the Subject Mater… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …on an international scale Experience preparing teams for and leading meetings with regulatory agencies, including the FDA Experience with rare disease drug ... difference? The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational medicines. You… more
- Merck & Co. (Durham, NC)
- …development, validation, and/or technology transfer.Experience authoring technical documents supporting regulatory filings ( FDA , EMA, JNDA).Knowledge of CFR, ... and techniques as they relate to laboratory testing start-up, regulatory requirements for method transfer/validation project timelines and budgetingBuild knowledge… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …SDLC related to pharmaceutical operations. required- 1 or More Years Direct dealings with FDA , EMA, PMRA, other regulatory agencies. preferred- 1 or More Years ... Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes the Global… more
- Merck & Co. (Rahway, NJ)
- …to identify, mitigate, and clearly articulate program risks.Demonstrated working knowledge of FDA , ICH, and other regulatory requirements for CMC, and ... to support formulation and process development and document technical reports and regulatory filings. The successful candidate will be key in implementing strategy,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Investigations, Corrections, and QMS records.Build the Site Readiness of MES for FDA and/or Other Regulatory Audits / Inspections.This individual is responsible ... for the training of Manufacturing Excellence on MES utilization and ensuring that Manufacturing Excellence properly assesses updates and impact.RequirementsBS/BA required in technical discipline: Engineering, science or similar field. Advanced degree… more
- Merck & Co. (Rahway, NJ)
- …phase drug product manufacturing processes to GMP production facilities.Experience authoring regulatory filings, and demonstrated working knowledge of FDA , ICH, ... packaging, compatibility characterization for processing and administration, and supporting regulatory filings.Collaborate with key stakeholders across the organizations (Research… more
- Aequor (Bothell, WA)
- …Documentation Practices.Comprehensive knowledge of SOPs, cGMPs, and other compliance requirements and regulatory guidelines ( FDA , EU) and the know-how to work ... and manage within a regulatory environment.Demonstrated leadership skills and the ability to negotiate in a complex environment.Excellent verbal and written… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …partnering with FDA . This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual ... US regulatory strategy for assigned project(s).Strategize and plan for FDA meetings for assigned product. Liaise, negotiate and orchestrate meetings with … more
- Merck & Co. (North Wales, PA)
- …history of successful interactions with the promotional review divisions of FDA (OPDP/APLB) or experience developing/leading the regulatory strategy for ... and approval of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Experience Qualifications7 or More Years in the pharmaceutical industry4 or More Years in regulatory affairs, NDA, sNDA, BLA filing to FDA Travel Ability to ... diseases and immune disorders. Summary Effectively liaise, negotiate and partner with FDA ; direct, coordinate and implement the preparation of all regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …partnering with FDA . This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual ... will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support... strategy for assigned project(s). Strategize and plan for FDA meetings.Serve as the primary contact with FDA… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Regulatory Affairs Headquarters Principal Scientist is responsible for development and implementation of global regulatory strategy for their ... not limited to:Functions with a high degree of independence and provides regulatory oversight for assigned products, functioning as the single, accountable, global … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help ... our strategic priorities.Summary, Focus and PurposeThe Senior Principal Scientist - Regulatory Affairs Liaison is responsible for development and implementation of… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help advance our ... pipeline and drive our strategic priorities.The Director, Principal Scientist - Regulatory Affairs Liaison is responsible for development and implementation of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Matter Expert (SME) in preparation for and during internal and external regulatory audits (including FDA , EMEA).Maintains various databases of production ... process changes/improvement.Partner with all stakeholders to implement process improvements.Assure regulatory compliance and technical feasibility of proposed changes.Serve as… more
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