ProSidian Consulting, LLC
Senior Regulatory Affairs SME | Healthcare and Life Sciences [HHS123028]
ProSidian Consulting, LLC, Washington, District of Columbia, us, 20022
Senior Regulatory Affairs SME | Healthcare and Life Sciences
ProSidian is a Management and Operations Consulting Services Firm focusing on providing value to clients through tailored solutions based on industry leading practices. Our services focus on the broad spectrum of Risk Management, Compliance, Business Process, IT Effectiveness, Energy & Sustainability, and Talent Management. We are seeking a Senior Regulatory Affairs SME | Healthcare and Life Sciences to support professional services engagement for Healthcare And Life Sciences Sector Clients such as HHS. This is a Full-Time ProSidian W-2 Healthcare and Life Sciences Functional Area - Healthcare And Life Sciences Supply/Service Initiative and an employed position with commensurate benefits and competitive salary. JOB OVERVIEW Provide services and support as a Healthcare And Life Sciences (Senior Regulatory Affairs SME) in the Healthcare And Life Sciences Industry Sector focusing on Human Capital Solutions for clients such as Department of Health and Human Services (HHS - ASPR | BARDA). RESPONSIBILITIES AND DUTIES Support BARDA Program Office(s) as a subject matter expert in the fields of Chemical Threats, Radiological/Nuclear Threats, Burn and Blast Injuries, or Biological Threats. Candidates with experience in the following areas are desired: medicinal chemistry; preclinical development; advanced clinical development; analytical product testing and testing development; quality control; clinical and/or regulatory policy; and/or manufacturing. Serve as advisor(s) on Technical Evaluation Panels (TEPs) to include white papers/market research abstracts, technical proposals, and budget proposals. Participate as subject matter experts on Program Coordination Teams (PCTs). Provide expert assessments, recommendations, and guidance as well as educational material to PCT and COR as needed. Desired Qualifications At least 15 years of senior-level industry experience in regulatory affairs. Significant experience in managing high-level regulatory challenges and strategic initiatives. Extensive FDA engagement experience, including authoring regulatory documents. Education / Experience Requirements / Qualifications Master’s degree or higher in biology, microbiology, chemistry, toxicology, pharmacy, or related field. Advanced education must be paired with commensurate industry experience in regulatory affairs or pharmaceutical development. Skills Required Expertise in regulatory affairs related to medical countermeasures (MCMs), including vaccines, therapeutics, and diagnostic devices. Strong understanding of FDA processes, regulatory guidelines, and compliance requirements. Excellent communication and strategic advisory capabilities. BENEFITS AND HIGHLIGHTS Competitive Compensation: Pay range begins in the competitive ranges with Group Health Benefits, Pre-tax Employee Benefits, and Performance Incentives. Group Medical Health Insurance Benefits: ProSidian partners with BC/BS, to offer a range of medical plans. 401(k) Retirement Savings Plan: 401(k) Retirement Savings Plans help you save for your retirement for eligible employees. ProSidian Consulting is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identity and expression, age, disability, or Vietnam era, or other eligible veteran status, or any other protected factor.
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ProSidian is a Management and Operations Consulting Services Firm focusing on providing value to clients through tailored solutions based on industry leading practices. Our services focus on the broad spectrum of Risk Management, Compliance, Business Process, IT Effectiveness, Energy & Sustainability, and Talent Management. We are seeking a Senior Regulatory Affairs SME | Healthcare and Life Sciences to support professional services engagement for Healthcare And Life Sciences Sector Clients such as HHS. This is a Full-Time ProSidian W-2 Healthcare and Life Sciences Functional Area - Healthcare And Life Sciences Supply/Service Initiative and an employed position with commensurate benefits and competitive salary. JOB OVERVIEW Provide services and support as a Healthcare And Life Sciences (Senior Regulatory Affairs SME) in the Healthcare And Life Sciences Industry Sector focusing on Human Capital Solutions for clients such as Department of Health and Human Services (HHS - ASPR | BARDA). RESPONSIBILITIES AND DUTIES Support BARDA Program Office(s) as a subject matter expert in the fields of Chemical Threats, Radiological/Nuclear Threats, Burn and Blast Injuries, or Biological Threats. Candidates with experience in the following areas are desired: medicinal chemistry; preclinical development; advanced clinical development; analytical product testing and testing development; quality control; clinical and/or regulatory policy; and/or manufacturing. Serve as advisor(s) on Technical Evaluation Panels (TEPs) to include white papers/market research abstracts, technical proposals, and budget proposals. Participate as subject matter experts on Program Coordination Teams (PCTs). Provide expert assessments, recommendations, and guidance as well as educational material to PCT and COR as needed. Desired Qualifications At least 15 years of senior-level industry experience in regulatory affairs. Significant experience in managing high-level regulatory challenges and strategic initiatives. Extensive FDA engagement experience, including authoring regulatory documents. Education / Experience Requirements / Qualifications Master’s degree or higher in biology, microbiology, chemistry, toxicology, pharmacy, or related field. Advanced education must be paired with commensurate industry experience in regulatory affairs or pharmaceutical development. Skills Required Expertise in regulatory affairs related to medical countermeasures (MCMs), including vaccines, therapeutics, and diagnostic devices. Strong understanding of FDA processes, regulatory guidelines, and compliance requirements. Excellent communication and strategic advisory capabilities. BENEFITS AND HIGHLIGHTS Competitive Compensation: Pay range begins in the competitive ranges with Group Health Benefits, Pre-tax Employee Benefits, and Performance Incentives. Group Medical Health Insurance Benefits: ProSidian partners with BC/BS, to offer a range of medical plans. 401(k) Retirement Savings Plan: 401(k) Retirement Savings Plans help you save for your retirement for eligible employees. ProSidian Consulting is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identity and expression, age, disability, or Vietnam era, or other eligible veteran status, or any other protected factor.
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