Reg Ops Manager Jobs (NOW HIRING)

ProSidian is a Management and Operations Consulting Services Firm focusing on providing value to clients through tailored solutions based on industry leading practices. ProSidian services focus on the broad spectrum of Risk Management, Compliance, Business Process, IT Effectiveness, Energy & Sustainability, and Talent Management.  We help forward thinking clients solve problems and improve operations. 
Launched by former Big 4 Management Consultants; our multidisciplinary teams bring together the talents of nearly 190 professionals globally to complete a wide variety of engagements for Private Companies, Fortune 1,000 Enterprises, and Government Agencies of all sizes.  Our Services are deployed across the enterprise, target drivers of economic profit (growth, margin and efficiency), and are aligned at the intersections of assets, processes, policies and people delivering value. 
ProSidian clients represent a broad spectrum of industries to include but are not limited to Energy, Manufacturing, Chemical, Retail, Healthcare, Telecommunications, Hospitality, Pharmaceuticals, Banking & Financial Services, Transportation, Federal and State Government Agencies.  Learn More About ProSidian Consulting at www.ProSidian.com.

ProSidian Seeks a Reg Ops Specialist SME | Healthcare and Life Sciences [HHS109014] - DPLH Est.: 1912 Hrs. ST | 0 Hrs. OT on a Exempt Full-Time Basis Mid Atlantic | ProSidian Labor Category - Executive Consultant/SME I Mid Level Professional aligned under services related to NAICS: 541611 - DPLH Est.: 1912 Hrs. ST | 0 Hrs. OT on a Exempt Full-Time Basis located CONUS - Washington DC Across The Mid Atlantic Region supporting Advanced Scientific Professional Staffing Support Services in the various areas of interest within the Medical Countermeasures field of Research and Development (R&D)/Analytical Research and Development (AR&D) of biotechnology and biopharmaceuticals supporting BARDA. These services are critical in support of BARDA's mission to conduct R&D and AR&D efforts to provide medical countermeasures that address the public health medical consequences of chemical, biological, radiological, and nuclear (CBRN) events, pandemic influenza, and emerging infectious diseases..

Seeking Reg Ops Specialist SME candidates with relevant Healthcare And Life Sciences Sector Experience (functional and technical area expertise also ideal) to support professional services engagement for Healthcare And Life Sciences Sector Clients such as HHS.  This as 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 (Reg Ops Specialist 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) | HHS Administration for Strategic Preparedness and Response (ASPR) Center for Biomedical Advanced Research and Development Authority (BARDA) Generally Located In CONUS - Washington DC and across the Mid Atlantic Region (Of Country/World).

RESPONSIBILITIES AND DUTIES - Reg Ops Specialist SME | Healthcare and Life Sciences [HHS109014]

• 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 (including viral and bacterial threats), Influenza and Emerging Infectious Diseases Division (IEIDD) as well as the research, development, manufacture, and regulatory approval/ licensure/ clearance of medical countermeasures against these threats including but not limited to diagnostics and other medical devices/infrastructure vaccines and other preventives, and therapeutics.
• Candidates with experience in the following areas are desired: medicinal chemistry; preclinical development (animal models, pharmacology, toxicology); advanced clinical development (medical officers  immunologists, clinical operations); analytical product testing and testing development; quality control; clinical and/or regulatory policy; and/or manufacturing (chemistry, manufacturing, and controls); process development, process scale-up and process optimization; device development and manufacturing, reliability engineering, Software, Assay chemistry, microbiology, virology, immunology. Plastic consumable design and manufacturing. Experience in manufacturing scalability and capacity expansion and sterile/aseptic technic, sterile manufacturing/filling and sterile facilities (sterile gowning) Provide guidance and recommendations on key issues related to the area(s) identified above.
• 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
• Provide subject matter expertise and advisory support to federal staff for development of cost estimates for notional programs/proposed work
• Review and comment on study protocols, study reports, regulatory documents, presentations, proposals, and related documents.
• Develop work products (including but not limited to expert summary reports, expert opinion assessment reports, analysis reports, manuscript writing/contribution, and review and technical assessments on a wide variety of documents related to BARDA's mission, including solicitations, white papers, proposals, and post-award contract documents and deliverables), as requested in their SME area and at their required level of expertise.
• Advise federal staff on the appropriateness and the probability of success of Contractor proposed statements of work Make suggestions on ways to improve those statements of work.
• Experience distilling complex information into informative and concise summaries, including providing risk/benefit analyses and balanced recommendations.
• Participate and aid in strategic discussions, working with USG, in building new program areas in alignment with BARDA's mission space.
• Provide recommendations for project development level portfolio management and oversight as required.
• Provide recommendations or advise on development, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts; Participate in Market Research efforts.
• Follow FDA submission requirements in consideration of BARDA Program Divisions and the regulatory operational requirements of BARDA core services including clinical, nonclinical, and manufacturing network services.
• Provide subject matter expertise for the management, design, publishing, review, submission, and archive of eCTD submissions, including amendments and original filing.
• Coordinate publishing and submitting of all electronic dossiers and documents to regulatory authorities and/or clients.
• Liaise with Regulatory Affairs Project Managers, and CROs directly, as necessary, to coordinate submission timelines and technical specifications and for client eCTD reviews.

Desired Qualifications For Reg Ops Specialist SME | Healthcare and Life Sciences [HHS109014] (HHS109014) Candidates:

• Bachelor's degree or equivalent qualification.
• At least 10 years of experience in leading regulatory operations supporting drug, biologic, and device development regulated by the FDA.
• Expertise in FDA submission types and eCTD specifications.
• Knowledge of ICH guidelines for CTD dossiers and electronic publishing.

Education / Experience Requirements / Qualifications

• Bachelor's degree or equivalent qualification in a relevant field.
• Additional certifications or training in regulatory operations and publishing software preferred.

Skills Required

• Superior competency in MS Word, Adobe Acrobat, and PDF toolsets (e.g., ISI Toolbox).
• Experience with electronic publishing software (e.g., Lorenz or similar tools) and XML document creation.
• Advanced knowledge of FDA and ICH submission requirements.
• Ability to self-train in specialized areas (e.g., CSR publishing, PEUA, EUA).

Competencies Required

• Strong project management skills for submission coordination and timeline management.
• Ability to design, review, and archive eCTD submissions, including original filings and amendments.
• Knowledge of FDA regulatory frameworks, guidelines, and operational requirements.
• Exceptional attention to detail in formatting, publishing, and dossier preparation.

Ancillary Details Of The Roles

• Provide subject matter expertise for managing and submitting electronic dossiers to regulatory authorities and clients.
• Liaise with regulatory affairs project managers and CROs to coordinate submission timelines and technical specifications.
• Expertise in compliance with US publishing guidance and ICH specifications for electronic submissions.
• Deliverables include properly formatted and compliant eCTD submissions, CSR publishing, and EUA filings.
• Support BARDA Program Divisions by aligning with regulatory and operational requirements.
• Provide training and guidance on publishing tools and FDA submission requirements

Other Details

• Knowledge of Accenture Starting Point preferred.
• Ability to provide strategic advice on submission planning and regulatory publishing improvements.
• Advanced skills in risk analysis and benefit assessment for submission success.
• Engagement in BARDA's mission to enhance regulatory readiness for medical countermeasure development.

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CORE COMPETENCIES

• Teamwork - ability to foster teamwork collaboratively as a participant, and effectively as a team leader
• Leadership - ability to guide and lead colleagues on projects and initiatives
• Business Acumen - understanding and insight into how organizations perform, including business processes, data, systems, and people
• Communication - ability to effectively communicate to stakeholders of all levels orally and in writing
• Motivation - persistent in pursuit of quality and optimal client and company solutions
• Agility - ability to quickly understand and transition between different projects, concepts, initiatives, or work streams
• Judgment - exercises prudence and insight in decision-making process while mindful of other stakeholders and long-term ramifications
• Organization - ability to manage projects and activity, and prioritize tasks

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OTHER REQUIREMENTS

• Business Tools -  understanding and proficiency with business tools and technology, including Microsoft Office. The ideal candidate is advanced with Excel, Access, Outlook, PowerPoint and Word, and proficient with Adobe Acrobat, data analytic tools, and Visio with the ability to quickly learn other tools as necessary.
• Business Tools - understanding and proficiency with business tools and technology, including Microsoft Office. The ideal candidate is advanced with Excel, Access, Outlook, PowerPoint and Word, and proficient with Adobe Acrobat, data analytic tools, and Visio with the ability to quickly learn other tools as necessary.
• Commitment - to work with smart, interesting people with diverse backgrounds to solve the biggest challenges across private, public and social sectors
• Curiosity - the ideal candidate exhibits an inquisitive nature and the ability to question the status quo among a community of people they enjoy and teams that work well together
• Humility - exhibits grace in success and failure while doing meaningful work where skills have impact and make a difference
• Willingness - to constantly learn, share, and grow and to view the world as their classroom

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BENEFITS AND HIGHLIGHTS

ProSidian Employee Benefits and Highlights: Your good health and well-being are important to ProSidian Consulting. At ProSidian, we invest in our employees to help them stay healthy and achieve work-life balance. That's why we are also pleased to offer the Employee Benefits Program, designed to promote your health and personal welfare. Our growing list of benefits currently include the following for Full Time Employees:

• Competitive Compensation: Pay range begins in the competitive ranges with Group Health Benefits, Pre-tax Employee Benefits, and Performance Incentives. For medical and dental benefits, the Company contributes a fixed dollar amount each month towards the plan you elect. Contributions are deducted on a Pre-tax basis.
• Group Medical Health Insurance Benefits: ProSidian partners with BC/BS, to offer a range of medical plans, including high-deductible health plans or PPOs. ||| Group Dental Health Insurance Benefits: ProSidian dental carriers - Delta, Aetna, Guardian, and MetLife.
• Group Vision Health Insurance Benefits:ProSidian offers high/low vision plans through 2 carriers: Aetna and VSP.
• 401(k) Retirement Savings Plan: 401(k) Retirement Savings Plans help you save for your retirement for eligible employees. A range of investment options are available with a personal financial planner ...