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Piper Companies is currently seeking a Regulatory Affairs Specialist, Cell & Gene Therapy for an opportunity in Philadelphia, Pennsylvania (PA), to join an innovative biotechnology company creating life-saving cell therapies.
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Regulatory Affairs Specialist – APAC - Diabetes Care (on-site) page is loaded. as part of the Regulatory Affairs Asia Pacific (APAC) team, on-site at our Diabetes Care Division HQ location in Alameda, CA. As an individual contributor, the function of a Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment.
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We invested in new offices, sector teams and practice groups including higher education; foundations and nonprofits; investor engagement; shareholder activism; governance; regulatory and public affairs, including geopolitical; crisis; litigation; social issues including climate change and diversity, equity and inclusion; cybersecurity, data and privacy; employee engagement; digital communications; opinion research and analysis, and; creative services.
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Minimum 5 years in Regulatory Affairs within any of the following industries: pet food, food, OTC drugs, medical devices or pharmaceuticals; 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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Bachelor's degree (BA/BS) in a scientific discipline required and advanced degree preferred with a minimum of 10 years' experience in drug development/regulatory affairs and a minimum 8 years in CMC regulatory affairs.
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The Vice President of Quality Assurance and Regulatory Affairs is a top executive responsible for overseeing all overall quality assurance and regulatory functions for Nitto Avecia and subsidiary companies.
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You will need to work closely with the Vice President, Global Regulatory Affairs Oncology and Precision Medicine, and collaborate with the biomarker team and global/regional regulatory liaisons to provide Precision Medicine global regulatory guidance.
$205,700 - $266,200Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Develop the profile of the global Regulatory and IPMT practice group - this includes the practice areas of Antitrust and Competition; Communications, Internet, and Media; Energy Regulatory; Government Relations and Public Affairs; International Trade and Investment; Pharmaceuticals and Biotechnology Regulatory; and Privacy and Cybersecurity.
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Interact regularly with multi-functional staff from Analytical Sciences & Quality Control, Drug Substance Process Development, Manufacturing Technical Services, Quality Assurance, and/or CMC Regulatory Affairs to support progress of the program and preparation of source documentation supporting BLA.
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Maintain clear communication channels with key stakeholders and partners (Development, Safety, Regulatory Affairs, HEOR, Medical Affairs, Precision/Molecular Medicine, and Genetics Research Center) to ensure team resources are focused on critical asset support and related initiatives.
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We are looking for an experienced Regulatory Affairs & Quality Assurance Lead to oversee our Mark I whole-body scanner regulatory submission and maintain market authorisation for our Gemini digital twin platform for compliance and commercial viability.
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As The Focus Of This Internship, We Would Like To Study The Potential For How Generative AI Can Be Used In The Drug Development Lifecycle To Accelerate The Approach To Areas Such As Regulatory Filings, Generation Of Real World Evidence, Clinical Trial Documentation And Audits.
$6,290 - $12,170 a monthInternExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The successful candidate will work collaboratively with the dynamic Federal Legislative Affairs team, as well as regulatory and business teams, to develop policy positions, formulate lobbying strategies, and coordinate Hill outreach to drive desired outcomes on critical issues.
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This 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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Work closely with State & Local Government Affairs and Regulatory Affairs on multi-tiered strategy that crosses our state footprint and at the federal level. Work closely with the federal affairs and regulatory affairs and policy teams on ongoing engagement of key legislative activity, including bill analysis and tracking; attending hearings, briefings and mark ups; and general legislative monitoring.
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regulatory affairs change control jobs Title: regulatory Company: Integrated Resources Inc Iri
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