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1035 Public Affairs Specialist. 0501 Stakeholder Relationship Tax Consultant. 1084 Visual Information Specialist. 0301 User Experience Designer (Interactive Designer) 0301 Digital User Experience Researcher.
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Partner with other teams involved in the end-to-end assay launch and maintenance processes, including Clinical Ops, Clinical Lab, Quality, Regulatory Affairs, Medical, Business Stakeholders, etc.
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PharmaLex is one of the largest worldwide providers of consulting services in the following focus areas: Quality Management & Compliance; Development Consulting & Scientific Affairs; Regulatory Affairs; and Pharmacovigilance, Epidemiology and Risk Management.
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Collaborate with cross-functional teams, including analytical development, formulation development, quality assurance, and regulatory affairs, to ensure seamless project progression. Collaborate with regulatory affairs to support regulatory submissions and inspections.
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Preferred Qualifications Experience working with legal counsel on regulatory and legislative affairs. The Virtual Power Plant Policy Director will lead SUN’s policy, regulatory, and advocacy efforts to implement solar + batteries Virtual Power Plant (VPP) policy across the country and in targeted states.
$80,000 - $90,000RemoteExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Additional duties may include the research and drafting of responses to regulatory data requests, enforcement actions, audits and assessments, monitoring of mandated activities, records & metrics to ensure the company's compliance with Federal and State regulatory requirements and promoting a culture focused on pipeline safety and operational compliance.
$99,000 - $116,000 a yearFull-timeExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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Work closely with NGS production, Quality and PreClinical Genotox for compliant execution of genotoxicity data packages in support of regulatory filings and clinical programs. Interact with Health Authorities, in writing and verbally, including pre-submission (e.g., pre-IND), scientific advice filings, IND or CTA, meeting briefing books, or other requests from global regulatory authorities.
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BS, BSc, MS, MSc, PhD, PharmD, J.D., M.D. in science or healthcare preferred or equivalent relevant experience and at least twenty (20) years of progressively responsible experience in regulatory affairs within the biopharmaceutical industry, or equivalent.
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Working closely with the Senior Director, Sustainability and Government Affairs and the company’s external ESG agency partner, inform and support the development and annual publication of a GRI and SASB compliant ESG report, as well as the completion of sustainability disclosures such as CDP.
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This position will report to the Senior Vice President, General Counsel Commercial and and will require you to work in a matrix setting in a fast paced, rapidly growing organization, partnering effectively with various stakeholders, including with colleagues in across the Commercial Legal team as well as Medical Affairs, Commercial, Regulatory, Ethics & Compliance, Privacy and other expertise areas at Alnylam.
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Over 15 years of progressive advancement within global regulatory affairs in the pharmaceutical /biotech industry. The Vice President, Regulatory Affairs & Quality is in charge of providing subject matter expertise on all matters related to FDA and global regulatory requirements, as well as leading the growth and responsibilities of the regulatory and quality department.
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Our clients include DHS, DHA, DoS, USMC, US Army, HHS/Indian Health Service, Department of Interior, Bureau of Indian Affairs, Bureau of Indian Education, among many more. Our clients include DHS, DHA, DoS, USMC, US Army, HHS/Indian Health Service, Department of Interior, Bureau of Indian Affairs, Bureau of Indian Education, among many more.
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In collaboration with the Associate Provost for Wellesley in the World advise the President, Provost, and VP/Communications and Public Affairs on the development of new partnerships or termination of existing partnerships.
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The ideal candidate must possess strong accounting, compliance, regulatory reporting and operational expertise, an ability to communicate and work with various teams outside of Finance (such as Legal/Compliance, Trading Operations and other Product/Engineering groups), and a desire to make a significant impact on a dynamic, high-growth technology company.
$161,500 - $190,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Collaborates with the cross-functional team comprised of regulatory affairs, clinical development, clinical operations, biostatistics, pharmacology, translational research, manufacturing, etc.
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regulatory affairs jobs Title: principal consultant in Waltham, MA
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