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The Director Regulatory Affairs position is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned development teams. Continually expands therapeutic are and disease state knowledge. Ensures strategic messaging and content of global regulatory dossiers. Serves as primary regulatory interface with
Posted 10 days ago
The Director of Alliance Management at Acadia plays a pivotal role in driving innovation through strategic collaborations. Responsible for cultivating partnerships and coordinating their integration, this role ensures Acadia's access to a diverse pipeline of pharmaceutical targets, assets, and technologies. The Director provides leadership in alliance activities, includin
Posted 16 days ago
The Director of Manufacturing is the Business lead, Technical Lead and primary contact responsible for managing Acadia's commercial Drug Product (DP) Contract Manufacturing Organizations (CMO's), and other third party suppliers. This position will also oversee the tracking of ongoing manufacturing, implementing process improvements, completion of quality investigations, a
Posted 16 days ago
Responsible for supervising outsourced analytical development activities associated with the development, validation, and technology transfer for chemical regulatory starting materials, intermediates and active pharmaceutical ingredients. Support characterization of Regulatory Starting Material (RSM), intermediates, and drug substances. Leads multiple contract service pro
Posted 16 days ago
Responsible for directing the regulatory aspects of internal and external communications including advertising and promotional activities as well as facilitation of labeling development, maintenance and distribution for all Acadia products. Coordinates the development and implementation of regulatory strategies for promotion and advertising plans and is a leader in the Me
Posted 17 days ago
Responsible for Preclinical and Clinical ADME (absorption, distribution, metabolism, excretion) and Pharmacokinetic deliverables across all of the therapeutic areas with a clear understanding of functional interdependencies and critical path activities. The Assoc. Director is an integral member of the project teams, represents the department and provides subject matter ex
Posted 22 days ago
Responsible for overseeing the design, execution and interpretation of statistical analyses for clinical trials focused on rare disease. Regularly interfaces with team members in R&D including Biostatistics and SAS Programming staff, Data Management, clinical research and operations teams, regulatory affairs, clinical pharmacology, medical writing, medical affairs and qua
Posted 22 days ago
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