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Executive Director Regulatory Affairs - Companion Diagnostics amp Precision Medicine Location. Ensure global regulatory plans support a precision medicine approach e.g. integrated drug/diagnostic regulatory and submission plans), including HA engagement plans and mitigation strategies.
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Experience in regulatory affairs and compliance, not necessarily in radiopharmaceutical or pharmaceutical production. Â Regulatory Affairs Certification programs will also be considered.
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The Sr. Regulatory Specialist, LATAM will prepare and submit regulatory compliance documents with regulatory authorities, and advise on regulatory affairs that stem from the U.S. Company's activities in the Latin American (LATAM) region.
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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 2 days ago - UpvoteDownvoteShare Job
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Mammoth is hiring a Director/Sr. Director, Regulatory Affairs, Therapeutics, to lead the regulatory activities of our growing CRISPR-based therapeutic programs as we bring them from concept to market.
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The Regulatory Specialist under the supervision of the Director of Accreditation and Regulatory Affairs has responsibility for site visit preparation, coordination of site visit logistics and response, as well as assist in preparing report-out to management of major regulatory changes and issues of mock or real survey results.
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The Senior Director, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations, Regulatory Affairs, Clinical Supply & Logistics, Sample Management and Pharmacovigilance as well as vendors supporting Scholar Rock sponsored Clinical Studies.
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You will be responsible for providing, scientific leadership, and collaborative working environment to advance the drug candidates from IND through Phase IV. In addition, this position will collaborate with cross-functional stakeholders including in vitro & In vivo pharmacology, clinical biomarkers, DMPK, clinical development and operations, regulatory, CMC, and medical affairs.
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Collaborate with IT business partners to identify and mitigate information security risks in key functional areas such as External Affairs (ESG), HR, Operations, Engineering & Construction, Development.
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Partner with Government Affairs to help positively shape the legal and regulatory landscape. Experience in other areas of law such as employment law, regulatory law, privacy, corporate law, or litigation would be a plus, but is not required.
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The Public Affairs Specialist intern will create lasting products for OSMRE while developing their own professional resume, skillset, and network to support long-term career aspirations.
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Depending on specific role, the Associate Director Regulatory Affairs may be involved in various regulatory activities (oversee activities for regulatory submissions; negotiate with regulatory authorities; oversee processes involved with maintaining annual licenses, registrations, ensure external communications meet regulations; lead crisis management program development and implementation; oversee and manage systems related to product safety issues and product recalls, project management, etc.
ExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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Communications / Contacts Internal - Departmental staff, business unit leaders/representatives, accounting managers, treasury and finance personnel, regulatory affairs cost of service department staff; and BHE corporate consolidations External - Federal Energy Regulatory Commission (FERC), Corporate Noteholders, Kansas Dept of Health & Environment, Environmental Protection Agency, auditing firms, IRS, pipeline journals.
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5-7 years of experience in regulatory preferred, but may consider quality assurance, research and development, scientific affairs, operations, or related area. Associate Director of Regulatory Affairs - Nutrition - Abbott Park, IL/Columbus, OH (OUS Ireland internal only) page is loaded.
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The position has oversight of strategic planning, fiscal affairs, staffing, fundraising and promotions, athletics facilities, regulatory compliance concerning Intercollegiate athletics, and general operations.
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regulatory affairs jobs Title: intern Company: Medxcel
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