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He/she manages the writing of response to CMC questions from Health Authorities with support from Quality, Global Regulatory Affairs (GRA), technical experts or CMOs. He/she defines and manages the compilation of the documentation, required for the authoring by reaching out to appropriate internal/external functions such as quality, manufacturing, Global Regulatory Affairs (GRA), technical experts from global locations or contract manufacturing organizations (CMOs), or alliance partners.
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Similar Jobs (5) Global Trade & Shopper Lead - Allegra locations 2 Locations time type Full time posted on Posted 30+ Days Ago Medical Safety Head, PV (CHC) locations 3 Locations time type Full time posted on Posted 30+ Days Ago US Regulatory Affairs Lead, OTC Brands locations Bridgewater, NJ time type Full time posted on Posted 3 Days Ago.
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Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and determine the impact of proposed labeling changes on product promotion. Broad knowledge of the pharmaceutical industry Regulatory Affairs discipline for prescription drugs.
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Partner with Manufacturing, Product Support, Microbiology, Regulatory Affairs, Quality Control Labs, Engineering and Compliance. Support/participate in external regulatory audits (FDA, TUV, Health Canada, Customers, etc.
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Demonstrated experience working with routinely collected data (claim databases, electronic medical (health) records, registries), and various structured and possibly unstructured data sources in the healthcare sector within pharmaceutical companies settings in commercial market access, medical affairs, scientific affairs and/or R&D environment.
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Reporting to the Executive Director of Development Quality Assurance, the Senior Director of Pharmacovigilance QA serves as a strategic partner managing quality and regulatory compliance related to Good Pharmacovigilance Practices (GVP) and other related activities performed by Drug Safety & Pharmacovigilance and Medical/Clinical Departments.
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Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, Regulatory Affairs. The Associate Director, Regulatory Affairs will be accountable for the development, implementation, and maintenance of robust North American regulatory strategies for therapies targeted to address unmet needs in pulmonary hypertension in different phases of development.
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Ensure close collaboration with other functional areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs, etc. Develops the process for ensuring that analysis data sets and outputs are compliant with regulatory requirements, including CDISC ADaM data set specifications, reviewer’s guides, etc.
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Establish and continuously optimize overall BSM processes across PrM. Support development of a strategy, including QCP, TS and CDx, and process to construct and execute plan document such as Pharmacokinetics (PK), Anti-Drug Antibody (ADA) and biomarker analysis plans, which aid in the construction of clinical development plans, clinical protocols, and in the submission of certain regulatory documents.
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Interacts with Medical Directors, Clinical Scientists, Regulatory Affairs, Preclinical scientists, Statistical Programming, Data Management, Medical Writing, and others to design and analyze clinical trials, as well as ensure the clinical program is appropriately designed.
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The Associate Director, US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the Rare Disease, Rare Blood Disorder and Neurology portfolio.
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Global Scientific Communications and Publications has responsibility for the development and delivery of internal and external scientific communication strategy and related tactics including global publications (e.g., abstracts, posters, manuscripts) and scientific materials such as slide decks for use by Medical Affairs around the world.
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Evaluate technical and regulatory requirements against business needs in development and maintenance of corporate level policies, procedures and strategies impacting all Ethicon, Inc sterile, single-use and reusable products, facilities and contractors.
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Knowledge of industrial control systems, sensors, automation, robotics, instrumentation, motion control, motor selection, encoders, electronic packaging, SEMI regulatory standards. The Mechanical Design Engineer is a key member of the New Product Development (NPD) and Engineered to Order (ETO) engineering teams, working on complex wafer processing equipment that is used to manufacture advanced semiconductors, LEDs, displays, photonics, VCSELs, power electronics, compound semiconductors, hard disk drives, MEMS and wireless chips.
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Interact with Medical Directors, Clinical Scientists, Regulatory Affairs, Preclinical scientists, Statistical Programming, Data Management, Medical Writing, and others to design and analyze clinical trials.
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regulatory affairs jobs Title: sr affairs associate in Bridgewater, NJ
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