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As part of the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. Join Takeda as a Senior Director, GRA Pharmaceuticals- Small Molecule where you will establish collaboration with Global CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives.
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Collaborate with Regulatory Affairs to ensure appropriate reporting of pharmacovigilance and drug safety information to regulatory agencies and prescriber community. 6+ years' experience in Drug Safety and Pharmacovigilance in pharmaceutical or biotech company, CRO or regulatory agency within Drug Safety/Pharmacovigilance, with both investigational and marketed products.
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Leads the Early Development Pharmaceuticals GRA CMC regulatory team in the development and implementation of global CMC regulatory strategies during development ,commercialization and post approval LCM stages.
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Comprising Communications, Government and Regulatory Affairs, Labor and Workforce, and Community Engagement, the External Affairs Department is responsible for shaping government policy to support offshore wind development and building support for projects by engaging with key stakeholders and delivering local benefits.
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The senior leader, Cardiovascular Medical Affairs will have a strong understanding of all phases of product development, including preclinical development, clinical trial management, market preparation and launch readiness, post-launch marketing, post-approval studies, regulatory affairs, GCP and manufacturing compliance.
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The Program Leader will lead a cross-functional team across clinical operations, regulatory affairs, clinical pharmacology, biomarkers, CMC, non-clinical, and medical to deliver against the program strategy.
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Collaborate with cross-functional teams, including Biology, Biologics, Clinical Operations, Clinical Development, and Regulatory Affairs functions, to align biomarker and CDx strategies with overall program objectives.
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Skills: CMC, IND, Regulatory Affairs Operations, Submissions, ICH Regulations, GMP (Good Manufacturing Practice) At least 3-5 years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity, with at least 3 years of experience in Regulatory CMC and preferably 2 years professional experience in pharmaceutical manufacturing, analytical development, or quality assurance/control or related technical field.
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Experience in Regulatory Affairs either via industry or education; knowledgeable of US and international regulations, requirements and guidance associated with clinical research and drug development.
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Advanced Degree in science, law, health policy, regulatory affairs or engineering and 8+ years of demonstrated experience in device, pharmaceutical/biologics regulatory, or scientific discipline including at least 3 years of demonstrated experience specifically in regulatory affairs work.
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The Principal Regulatory Affairs Specialist will prepare comprehensive regulatory strategies for complex new devices and post market changes within our Ultrasound business. Principal Regulatory Affairs Specialist (U.S. Hub based location.
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Over 15 years of progressive advancement within global regulatory affairs in the pharmaceutical /biotech industry. The Vice President, Regulatory Affairs & Quality is in charge of providing subject matter expertise on all matters related to FDA and global regulatory requirements, as well as leading the growth and responsibilities of the regulatory and quality department.
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The Executive Office of Energy and Environmental Affairs Secretariat (EOEEA) provides oversight of the Commonwealth’s energy and environmental agencies, namely, the Division of Energy Resources (DOER), Department of Public Utilities (DPU), Department of Environmental Protection (DEP), Department of Conservation and Recreation (DCR), Department of Fish and Game (DFG), and Department of Agricultural Resources (DAR.
$48,776 - $64,681.5 a yearFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Maintain required documentation according to DDS, DMH, MassHealth, HUD, DPH, CARF and all applicable regulatory standards as well as Bridgewell policies and procedures. Provide services to individuals according to DDS, DMH, MassHealth, HUD, DPH, CARF and all applicable regulatory standards, as well as Bridgewell policies and procedures.
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The Regional Director(s), Medical Affairs Medical Science Liaison (MSL) will report to the National Sr. Director, Medical Affairs Medical Science Liaison (MSL’s). Requires 7+ years of experience in medical affairs with 3+ years focus on field medical capabilities, or equivalent combination of education and experience.
$203,760 - $305,640 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago
regulatory affairs jobs Title: sr regulatory associate in Medford, MA
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