1,392 Environmental Protection Agency jobs in the United States

Goldbelt Professional Services specializes in providing expert resources for Public Health missions including scientific, technical, and administrative support from junior staff to high-level subject matter experts. Research and data driven, Goldbelt Professional Services' experts create solutions customized to the client's needs.

The Regulatory Affairs Manager V (Regulatory Affairs) for the JPM CBRN Task Order 3 contract shall serve as a liaison at the One RAQA Program Office, between the AJPEO MRAS regulatory office and product leads to ensure DoD-funded regulatory Sponsors developing MCMs are complying with relevant laws, regulations, and current guidance.

Essential Job Functions:

• Serve as a subject matter expert in regulatory affairs at the working group-level to inform innovative regulatory approaches to develop MCMs against emerging threats.
• Elevate critical programmatic and project level regulatory challenges to the AJPEO MRAS regulatory office on critical programmatic and project level regulatory challenges.
• Provide training and advisement to DOD staff on regulations, authoring regulatory documents, and interactions with regulatory authorities.
• Provide input to Sponsors' regulatory documents for submission to FDA or other National Regulatory Authorities (NRAs) and coordinates/prepares and maintains FDA filings (such as INDs, NDA, BLAs, PMA, 510(k), EUA, etc.) in accordance with US FDA or other National Regulatory Authority requirements and with the eCTD submission format, as applicable.
• Review, draft, manage, maintain and retain regulatory documentation (e.g. TPPs, regulatory strategies, regulatory assessments or whitepapers, study protocols/reports, correspondence with Regulatory Agencies, official briefing packages, submissions, and other relevant regulatory documentation) in accordance with approved business rules in the assigned electronic document management system.
• Contribute to the modification, development and implementation of internal policies and procedures.
• Represent the regulatory team, provide regulatory guidance to assigned product teams, and facilitate cross-communication with the interdisciplinary team. In addition, the contractor shall present, orally and in writing, the outcome of these efforts in a timely manner and participates in regulatory audits/inspections as required.
• Plan, prepare and execute meetings with regulatory agencies on complex and strategic programs; negotiate complex issues with regulatory bodies Provide advice and aid in the implementation of quality systems and procedures to ensure compliance with all applicable laws, regulations, and organizational quality standards in support of advanced development activities.
• Conducts quality audits and oversight, as assigned for non-clinical and/or clinical and/or manufacturing activities in compliance with relevant laws, regulations and policies.
• Create and/or review acquisition and contract documents ((e.g., Requests for Proposals (RFPs), Source Selection Evaluation Boards (SSEBs), etc.).) to ensure regulatory and quality requirements are appropriate and consistent with FDA regulations and assess the impact of these requirements to the product development timeline.
• Collaborate and network with internal/external regulatory professionals and clinicians, as well as investigators and researchers, and other scientific and technical disciplines to maintain current knowledge in the Chemical, Biological, Radiological, and Nuclear (CBRN), Emerging Infectious Disease (EID), and other relevant emerging and re-emerging threat spaces.
• Travel for presentations and seminars, and to observe and provide regulatory assessments of supplier evaluation visits (e.g., due diligence, mock audits, vendor qualifications, etc.).

Necessary Skills and Knowledge:

• Shall possess the ability to work on a multi-disciplined team in a DoD acquisition environment.
• Possess the ability to perform multiple task simultaneously and rapidly redirect efforts based on changing requirements.
• The contractor shall possess strong writing and oral communication skills.

Minimum Qualifications:

• Bachelor's or Master's degree in Life Sciences, Public Health, Medical, Nursing, Pharmacy, Veterinary, Epidemiology or a related discipline, as well as fifteen (15) years of general experience and ten (10) years of relevant experience.
• Experience in developing and implementing regulatory strategies and overseeing regulatory filings (such as INDs, NDA, BLAs, PMA, 510(k), EUA, etc.).
• Experience with providing critical review of documentation supporting regulatory applications.
• Possess and maintain a mastery of relevant drug and/or biologics and/or devices, and/or combination medical product laws, regulations and policies (e. g. FDA regulations, ICH guidelines).
• Experience with medical product development requirements under the FDA Animal Rule regulatory pathway, including animal model development, pharmacokinetics, pharmacodynamics, and toxicity.
• Mastery of FDA and other relevant regulatory authorities' requirements for clinical study development and implementation and marketing and post- marketing.
• Experience applying this expert knowledge to products made available through normal approval processes or emergency use mechanisms.
• Clearance: Secret

Preferred Qualifications:

• Certification in Regulatory Affairs or other certification relevant to medical product development and/or auditing is desired and will be at no cost to the Government.

Pay and Benefits:

The salary range for this position is $150,000- $170,000 annually. At Goldbelt, we value and reward our team's dedication and hard work. We provide a competitive base salary commensurate with your qualifications and experience. As an employee, you'll enjoy a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan with company matching, tax-deferred savings options, supplementary benefits, paid time off, and professional development opportunities.

ProSidian is a Management and Operations Consulting Services Firm focusing on providing value to clients through tailored solutions based on industry-leading practices. ProSidian provides Enterprise Service Solutions for Risk Management | Compliance | Business Process | IT Effectiveness | Engineering | Environmental | Sustainability | and Human Capital. We help forward-thinking clients solve problems and improve operations. Launched by Management Consultants, our multidisciplinary teams bring together the talents of Global Professionals to complete engagements for public/private companies, defense and civilian government agencies, and non-profit organizations. Our solution-centric services are deployed across the enterprise and target drivers of economic profit (growth, margin, and efficiency). They are also aligned at the intersections of assets, processes, policies, and people delivering value.

ProSidian clients represent a broad spectrum of Industry Sector Groups, including but not limited to -- Sector Groups including but not limited to Consumer Products, Services, And Retail | Defense And Military | Education And Academia | Emergency Services | Energy, Infrastructure, And Environment | Financial Services | Food And Agriculture | Foreign Aid / Technical Assistance | Government And Public Services | Healthcare And Life Sciences | Industrial And Commercial | Manufacturing And Operations | National Security & Intelligence | Non-Profit | Professional Services | Real Estate And Hospitality | Technology, Media, And Telecommunications | Transport And Logistics | etc. Learn More About ProSidian:

ProSidian Seeks a Permitting & Regulatory Affairs Manager | Regulatory Strategy & Environmental Compliance (PCBOCC ) for Program Support on a Exempt 1099 Contract: No Overtime Pay Basis Technical Element located CONUS - Pasco County Across The South East Region supporting Pasco County in enhancing performance, resilience, and sustainability of its water, wastewater, and reclaimed water systems through comprehensive engineering, planning, environmental, and digital transformation services.

Seeking Permitting & Regulatory Affairs Manager candidates with relevant Energy, Sustainability & Infrastructure Sector Experience (functional and technical area expertise also ideal) to support professional services engagement for Energy, Sustainability & Infrastructure Sector Clients such as PCBOCC. This is a Technical Element or Contract W-2 (IRS-1099) Regulatory Strategy & Environmental Compliance Functional Area Professional - Planning, Permitting, and Project Management Position; however, ProSidian reserves the right to convert to a Full-Time ProSidian employed W-2 Position.

JOB OVERVIEW

Provide services and support as a Planning, Permitting, and Project Management (Permitting & Regulatory Affairs Manager ) in the Energy, Sustainability & Infrastructure Industry Sector focusing on Environmental Services Solutions for clients such as Pasco County Board of County Commissioners (PCBOCC) | Pasco County Utilities Generally Located In CONUS - Pasco County and across the South East Region (Of Country/World).

RESPONSIBILITIES AND DUTIES - Permitting & Regulatory Affairs Manager | Regulatory Strategy & Environmental Compliance (PCBOCC )

• Oversee all environmental and utility-related permitting across categories and agencies.; Ensure compliance with state, federal, and local utility regulations.; Coordinate across departments to maintain up-to-date permitting and regulatory systems.

Desired Qualifications For Permitting & Regulatory Affairs Manager | Regulatory Strategy & Environmental Compliance (PCBOCC ) (PCBOCC ) Candidates:

• Bachelors in Environmental Science, Engineering, or Public Administration; legal/regulatory credentials a plus.

Education / Experience Requirements / Qualifications

• 710 years in permitting, compliance, or regulatory strategy roles for public utilities.

Skills Required

• Permitting workflows, regulatory analysis, stakeholder management, environmental reporting.

Competencies Required

• Policy interpretation, communication, compliance tracking, public sector alignment.

Ancillary Details Of The Roles

• Lead regulatory response during audits and public inquiries.
• Support legislative tracking and rule change impact evaluations.

Other Details

• Supports project delivery schedules, CEI compliance, and permitting for design, O&M, and capital work.

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As a condition of employment, all employees are required to fulfill all requirements of the roles for which they are employed: establish, manage, pursue, and achieve annual goals and objectives with Documented Goals for each of the firm's Eight ProSidian Global Competencies (1 - Personal Effectiveness | 2 - Continuous Learning | 3 - Leadership | 4 - Client Service | 5 - Business Management | 6 - Business Development | 7 - Technical Expertise | 8 - Innovation & Knowledge Sharing (Thought Leadership)); and to support all business development and other efforts on behalf of ProSidian Consulting.

CORE COMPETENCIES

• Teamwork the ability to foster teamwork collaboratively as a participant and effectively as a team leader
• Leadership the 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 workstreams
• Judgment exercises prudence and insight in the decision-making process while being mindful of other stakeholders and long-term ramifications
• Organization the ability to manage projects and actions 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, proficient with Adobe Acrobat, data analytic tools, and Visio, and 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, proficient with Adobe Acrobat, data analytic tools, and Visio, and the ability to quickly learn other tools, as necessary.
• Commitment - to work with intelligent, interesting people with diverse backgrounds to solve the most significant 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 an 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 essential to ProSidian Consulting. At ProSidian, we invest in our employees to help them stay healthy and achieve work-life balance. We are also pleased to offer the Employee Benefits Program, designed to promote your health and personal welfare. Our growing list of benefits currently includes the following for Full-Time Employees:

• Competitive Compensation: The pay range begins in the competitive ranges with Group Health Benefits, Pre-tax Employee Benefits, and Performance Incentives. The Company contributes a fixed dollar amount each month towards the Plan you elect for medical and dental benefits. 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 is available with a personal financial planner to assist you. The Plan is a pre-tax Safe Harbor 401(k) Retirement Savings Plan with a company match.
• Vacation and Paid Time-Off (PTO) Benefits: Eligible employees use PTO for vacation, a doctor's appointment, or any number of events in their life. These benefits include Vacation/Sick days 2 weeks/3 days | Holidays - 10 ProSidian and Government Days are given.
• Pre-Tax