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O Leadership: This position requires the regulatory affairs manager to exhibit empathy, self-awareness, social skills, understand team dynamics, manage conflicts, and foster a positive work environment by encouraging collaboration, promote trust, and empower team members to excel.
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You will lead CMC-regulatory activities listed above with cross-functional teams and act as the regulatory CMC liaison between CMC, regulatory affairs and/or program management, as applicable.
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We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
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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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More details on our benefits can be found on our website at to the Chief Compliance Officer, the Assistant General Counsel - Regulatory Affairs provides legal support to each of ITW’s Segments and Corporate functions as needed on a variety of regulatory matters, with a principal focus on monitoring and advising ITW businesses regarding existing and developing legal and regulatory issues affecting the company’s operations and products.
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This role will involve extensive cross-functional collaboration with teams including Medical Affairs, Regulatory Affairs, Legal, Sales, Market Access, and Insights & Analytics. Cross-functional collaboration with Medical Affairs, Legal, Regulatory, Patient Services, Market Access, Data & Analytics, Market Insights, Competitive Intelligence, and US Commercial Field teams to support promotional activities.
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Act as a liaison between the preclinical research team and other departments such as clinical development, regulatory affairs, and quality assurance. As a Preclinical Study Director, you will oversee the planning, execution, and reporting of preclinical studies in compliance with regulatory standards (e.g., GLP.
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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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Policy Advocacy: Lead lobbying efforts on specific healthcare proposals and bills, influencing legislation and regulatory issues to align with company interests. The Director of LATAM Government Affairs will have the unique opportunity to leverage their expertise and leadership skills, working with a diverse team to influence and shape public policy across Latin America.
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The Regulatory Affairs Specialist will reside within strategic business unit, Huber Specialty Minerals (HSM), at Huber Engineered Materials (HEM). Serve as primary contact for HSM hazard communication support and collaborate with HEM regulatory affairs for SDS/Labeling support.
$120,300 a yearFull-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Collaborating with members of all departments within the company, including but not limited to Offshore Wind Development, Onshore Development, Origination, Transmission, Regulatory, and Environmental Compliance & Strategy.
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Texas Oncology is looking for a Regulatory Affairs Coordinator to join our team! Minimum 3 years of experience in clinical research, regulatory affairs and/or an oncology related field required.
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The position is responsible for leading CMC regulatory activities within the Regulatory Affairs department, to support all ORIC’s clinical development programs of oncology products.
$235,000 a yearFull-timeExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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Experience working in electric and gas utility industry as in a capacity that deals with local governments and regulatory agencies, community and special interests groups, public policy and/or experience working for a local or state elected official, municipality or agency as a political consultant or in similar work for a business or association or other experience related to the position is an advantage.
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This Regulatory Affairs Manager – Digital Health Technology will work on-site at our Alameda, CA location in the Diabetes Care Division. This Regulatory Affairs Manager – Digital Health Technology will provide support for the regulatory department to ensure efficient and compliant business processes and environment.
$218,500 a yearFull-timeExpandApply NowActive JobUpdated 23 days ago
regulatory affairs jobs Title: travel nurse Company: Supplemental Health Care in LA, Utah
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