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Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in Research and Development, Regulatory Affairs, and Clinical Development.
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Provides advice to clinical development, commercial, and medical affairs senior leaders/teams on broad regulatory aspects of clinical study design, labeling, and submission.
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Collaborate with Research & Development, Scientific Affairs, and Laboratory staff in any way applicable to support Clinical Trials. As a part of Clinical Trials Scientific Affairs, the Principal Scientist will support testing, method development and validation.
$115,000 - $130,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Develop effective collaborations with research project leaders and projects team members, including biostatistics, regulatory affairs, clinical pharmacology, clinical scientists and development operations.
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Requirements: BSc or MSc level degree preferably within the life sciences (PharmD, PhD preferred) Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Oncology and/or immunology and inflammation is preferred) Prior experience of direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA) A solid understanding and experience in drug development including early and late development is highly preferred.
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We are seeking a driven, creative, collaborative, and highly respected individual who is passionate about public policy, government affairs, regulatory policy, helping patients, innovative science, biotechnology, and public health to serve as Vice President, Policy & Advocacy.
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The Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Represent the Regulatory Affairs function internally to improve awareness, visibility, and communication on regulatory requirements to support company goals and priorities.
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Create and foster a climate of teamwork and effective working relationships both within Regulatory Affairs and with our internal business partners: Quality, Marketing, Legal, New Product Innovation, Science & Technology, Professional Veterinary Affairs, Supply Chain, and others to achieve the synergy needed to effectively work as a team and promote the business.
$128,000 - $150,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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This role collaborates cross-functionally with key cross-functional partners including other GMA functions, Clinical Development/Operations, Regulatory Affairs, Corporate Communications/IR, Legal, Market Access and Commercial, and Research.
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I have a talented group of recruiters who specifically source Technical Sales Professionals, Scientists, Regulatory Affairs, Scientific Affairs, Executive Technical professionals, Quality Assurance, Product Development, Technical Service, Nutrition, Analytical and Corporate Chefs.
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Conduct assessments and identify areas of improvement to regulatory aspects of drug development and commercial operations; propose and implement process improvementsAll other duties as assigned;The Candidate Bachelor’s Degree in in a life science with 5+ years of experience in Regulatory Affairs, Quality Assurance or related field or any combination in a manufacturing, pharmaceutical and/or GMP facility required.
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IFDC uniquely approaches the global issues of food security and poverty by bridging the gap between research and impact, combining science-based innovations, holistic market systems development, an enabling policy environment, and strategic partnerships to assist farmers and countries to identify and scale sustainable agricultural solutions, including improved nutrient use efficiency.
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In conjunction with the AVP, Medical Affairs NA - Biologics and Market Access, will be the responsible member of the Sun Pharma medical department in regulatory interactions, ISS and expert advisory board meetings, external professional societies, seminars, and conventions.
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With our strong investment in research and development and our culture of continuous improvement, Hexcel is the industry leader in the manufacturing of advance composite materials, including carbon fiber, woven reinforcements, resins, prepregs, honeycombs and additive manufactured parts.
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Within URAD, the departments of Development, SDSU Alumni, Planned Giving, Special Events, Donor Relations, Marketing and Communications, Financial Management, Data Management, Prospect Research and Management and Operations are making a difference in the lives of SDSU’s 37,000 students.
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regulatory affairs research and development overnight travel jobs Title: medical director
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