- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the labeling leadership, the manager will develop, review and revise labeling for FDA submission, create and modify Structured Product Labeling for FDA ... in the development, revision, review, and approval of labeling content for submission to FDA , as well as any post marketing labeling changes. Review new labeling for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of our cutting-edge assets by effectively liaising, negotiating and partnering with FDA . This role will create and implement effective regulatory strategies to ... implement US regulatory strategy for assigned project(s).Strategize and plan for FDA meetings for assigned product. Liaise, negotiate and orchestrate meetings with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... maintaining product and establishment registrations (drug/establishment listings) and submission to FDA databases. This individual acts as the Subject Mater Expert… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of our cutting-edge assets by effectively liaising, negotiating and partnering with FDA . This role will create and implement effective regulatory strategies to ... regulatory strategy for assigned project(s). Strategize and plan for FDA meetings.Serve as the primary contact with FDA... FDA meetings.Serve as the primary contact with FDA and liaise, negotiate and orchestrate meetings and teleconferences… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …assets within the alliance by effectively liaising, negotiating, and partnering with FDA . This role will create and implement effective regulatory strategies to ... and provide US regulatory support; meet aggressive deadlines to ensure that FDA receives timely and quality submissions, shortening the review process and leading… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Summary Effectively liaise, negotiate and partner with FDA ; direct, coordinate and implement the preparation of all regulatory submissions ... corporate goals.ResponsibilitiesLiaise, negotiate and orchestrate meetings and teleconferences with FDA ; strategize and plan for FDA meetings; capture… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Independently lead cross functional teams through all labeling discussions with the FDA /CHMP while ensuring management alignment. Strategize and plan for FDA ... Independently leads cross functional teams through all labeling discussions with the FDA /CHMP while ensuring management alignment. Strategizes and plans for FDA … more
- Merck & Co. (Rockville, MD)
- …health policy, or lawDoctorate degree and at least 5 years' experience with FDA or other health authority, either directly (working within a health authority) or ... ORMaster's degree and at least 8 years' experience with FDA or other health authority, either directory (working within...ORBachelor's degree and at least 10 years' experience with FDA or other health authority, either directly (working within… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... and disseminate critical CMR training documentation Ensures training and compliance to FDA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …etc.)Develops less complex Module 1 regulatory documents (eg cover letter, FDA forms, administrative information, letter of authorization, etc.) for US regulatory ... of health authority response as appropriate.Coordinates processes for core BB or FDA BB preparation, creates previous history section, drafts meeting request based… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Independently leads cross functional teams through all labeling discussions with the FDA /CHMP while ensuring management alignment. Strategizes and plans for FDA ... meetings as needed. Acts as point of contact for cross-functional teams on RA labeling issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU.Ensure Compliance with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... conduct of clinical trials In-depth knowledge & direct experience/interactions with the FDA (or equivalent regulatory authority) in relation to the design, planning… more
- Lundbeck (Tucson, AZ)
- …and regulatory environment, including Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. ... healthcare economy and industry practices. Accountability and adherence to corporate, FDA , and PDMA guidelines.REQUIRED EDUCATION, EXPERIENCE and SKILLS: Bachelor of… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …methods for raw material, in-process, and finished product per USP and FDA guidanceProvides work assignments with communication of the expected timelines to ... auditing and handling of external audits by customers and FDA during departmental reviewPurchase equipment and materialsHire and train staffMay… more
- Merck & Co. (Rahway, NJ)
- …strategy.Knowledge of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human ... Factors guidance, ISO 14971, 11608 and 11040, EN 62366, Council Directive 93/42/EEC, etc.Proven track record of applying analytical skills in product design, development, and validationSelf-motivated with ability to work independentlyProven ability to lead… more
- Aequor (Chattanooga, TN)
- …Good Manufacturing Practices (GMP) Compliance, and Food and Drug Administration ( FDA ) regulatory standards. Maintain compliance with all state and federal ... Peer Relationships, Directing Others, and Comfort Around Higher Management o Experience in Food or Pharma manufacturing following FDA regulations is preferred. more
- Aequor (Thousand Oaks, CA)
- …of Quality Management System Requirements, Product Standards / Regulatory Requirements (eg FDA CFRs for Biologics and Medical Devices, FDA Combination Product ... Regulation, ISO:13845, EU Medical Device Directive, EN 60601and IEC/EN 62304) Experience supporting pre-clinical, clinical research, and/or pharmacovigilance activities Ability to read, analyzes, and interprets general business periodicals, professional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Independently lead cross functional teams through all labeling discussions with the FDA /CHMP while ensuring management alignment. Strategize and plan for FDA ... meetings as needed. Acts as point of contact for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other regions, including Japan, while developing the CCDS.Ensure Compliance with Core Data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulatory trends, legislative changes, and guidelines issued by global regulatory agencies ( FDA , EMA, MHRA, etc.) related to CSPV. Participates in the review and ... of Adverse Event and drug coding conventions (MedDRA, WHO-DD)- Knowledge of FDA and global PV regulations, clinical and safety databases- Familiarity with Good… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to extract configurable data fields from a study protocolProficient in FDA regulations supporting the submission of adverse events for post-marketing and ... of MedDRA structureUnderstanding and application of guidelines detailed in FDA 21 CFR Part 11, including system validation requirementsAdvanced understanding… more
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