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The applicant should join SPARC to take the leadership position for clinical regulatory affairs strategy in a dynamic and rapidly growing novel drug discovery company. The position is to provide regulatory affairs strategic leadership for SPARC and supported Sun novel drug development programs.
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The Vice President of Global Strategic Regulatory Operations (GRSO) reports directly to the Senior Vice President of Global Regulatory Safety and Biometrics (GRSB) and is a member of the GRSB Leadership Team. As such, this position has accountabilities for the sustained health, growth and continuous improvement of the GRSB organization, inclusive of developing effective partnerships with critical stakeholders across the BMS enterprise.
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The Team Lead for Authoring Support Group will be part of the Global Regulatory Operations group and will develop and manage the authoring support group within Regulatory Affairs (RA) to ensure timely and high-quality document delivery to the Regulatory Publishing Group.
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Familiarity with EDC, IRT, eTMF, CTMS, SAS, Argus, clinical analytics, safety, LMS, QMS, TraceLink, Veeva Vault and/or regulatory systems. Solid domain knowledge of business processes and related data types in functional areas (Pre-clinical, clinical development, clinical operations, regulatory, pharmacovigilance, biostatistics, data management, quality, and manufacturing), to support technology solutions.
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Additional tasks are required to support the continuous improvement of the Otsuka Quality System, inspection management, regulatory intelligence activities, SOP and WP management, validation activities, and project liaison activities.
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The wide array of responsibilities includes: capital project support for soil and groundwater management, air pollution, asbestos, lead, radon, stormwater, underground storage tanks, dam inspection, due diligence investigations associated with property acquisitions as well as review of all new environmental regulatory legislation and potential impacts.
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Key matrixed partners included: Brand Marketing, Creative / CRM / Digital agencies, Media, Market Research, Analytics, Otsuka Information Technology (OIT), Sales Operations, and Medical/Regulatory/Legal integrated business partners.
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Ensure Product roadmaps align to Regulatory strategy, established architectural principles and patterns, and enterprise ALM/TLM requirements. At least 5 years of experience in a Solution Architect role serving the Regulatory Information Management domain.
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Proficiency with drug safety databases (i.e., Argus), electronic data capture (EDC) systems, Medical Dictionary for Regulatory Activities (MedDRA) and World Health Organization (WHO) Drug dictionary coding.
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Ensure the local HSE management system is effectively designed, implemented, and controlled and meets Firmenich standards, ISO standards, and all relevant regulatory requirements. Thorough knowledge of OSHA regulations and experience working with regulatory agencies.
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Interact routinely and will develop a strong team environment with colleagues throughout GRSRequirements:Ph. D., M.D., PharmD. , MS or commensurate experienceSignificant experience in regulatory affairs (e.g. 3-5 years)Expert understanding of policy, laws, regulations and guidelines as they apply to U.S. FDA for drug development and approval.
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Lead the launch planning process for APOC’s game-changing TBI test; define regulatory, market access, pricing, distribution, sales force organization and promotion strategies and develop sales forecasts.
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Create using multiple flavor delivery systems and flavor creation suitable for clean and clear labelling including systems for beverage including emulsion, encapsulation and spray drying within local regulatory guidelines.
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Assist in coordinating other aspects of fragrance development- such as scheduling category reviews, base/product requirements, ensure suppliers are adhering to CHD & regulatory requirements. Writing & executing briefs for new projects, base changes, feasibility studies, flavor modifications, regulatory mandates.
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Demonstrated track record in leading cross-functional teams and work streams (e.g., translational medicine, biostatistics, regulatory, pre-clinical pharmacology, clinical and immunogenicity assay development.
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regulatory apd jobs Company: Metroplus Health Plan in Cranbury, NJ
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