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A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 15 years with a BA/BS, MA/MS, PhD or PharmD. Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc.
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A scientific degree with directly relevant professional experience in small molecule product development, global CMC regulatory affairs, and CMC technical areas of at least 12 years with a BA/BS or 10 years with an MA/MS, PhD, PharmD, or MD.
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BryceTech is looking for an experienced Regulatory Affairs Analyst to support the DHS FEMA, Office of Response and Recovery, CBRN program, supporting the Office of Emerging Threats Professional and Technical Services Contract.
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What we look for: A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 20 years with a BA/BS, MA/MS, PhD or PharmD. Demonstrated organizational leadership skills at both functional and enterprise levels.
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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. Regulatory Affairs Specialist.
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A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 20 years with a BA/BS, MA/MS, PhD or PharmD. 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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2) Business Relationship Management: • Foster close relationships with the Care Chemicals business and technology personnel, Quality Managers, as well as Global Product Stewardship & Regulatory Affairs colleagues, Trade Associations, and/or NGOs. • Develop and document business-specific PSRA objectives and strategies aligned with the overall business strategy.
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Oversee regulatory affairs operations including the VEEVA regulatory information management (RIM) platform, and the artwork management system for both Civica owned and private label distribution products.
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As a Regulatory Affairs Specialist, you'll play a pivotal role in upholding our mission by ensuring regulatory compliance and promoting the well-being of pets worldwide. As a Regulatory Affairs Specialist, you'll be an integral part of our mission-driven team, working collaboratively to ensure that our products meet the highest standards of safety, quality, and regulatory compliance.
$95,000 - $113,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Project Manager, CMC Regulatory Affairs will be responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products.
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Position SummaryThis position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients.
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The Regulatory Affairs Specialist will provide regulatory support for the Catalent Cell and Gene Therapy sites. This position will evaluate facility change controls for compliance with applicable change control guidance and will maintain site master files and Type V DMFs. In addition, the Regulatory Affairs Specialist will provide audit support and assist in preparing for group meetings and communications as appropriate.
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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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This position will receive continuous guidance and mentoring by the Director of Regulatory Affairs and/or the Deputy Chief Regulatory Officer and the Chief Regulatory Officer, as applicable.
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Counsel and advise the BU in areas of product safety (including TSCA, FIFRA, FDA, OSHA Hazard Communication, Hazardous Materials Transportation), product regulatory affairs, product stewardship, and product risk management as such areas may impact the research, development, manufacture, marketing, sale, handling, transportation and advertising of the BU(s) products.
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regulatory affairs jobs Company: Civil Environmental Consultants Inc
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