1,305 Drug Regulations 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.

Join to apply for the Manager, Regulatory Affairs role at Baylor College of Medicine Summary The Regulatory Affairs Manager provides analytical, regulatory, and supervisory support for the clinical research/regulatory team at The Center for Cell and Gene Therapy (CAGT). This includes training and supervising regulatory staff, helping investigators develop regulatory strategies, and analyzing regulatory changes affecting CAGT protocols. The Manager works closely with the Director to oversee all aspects of clinical research within CAGT. The role is fast-paced and high-profile, requiring strong concentration, understanding of complex scientific concepts, and multitasking skills. The ideal candidate will be highly organized, intelligent, motivated, and possess strong problem-solving skills. The position offers a hybrid work schedule. Employees with Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) certifications are eligible for certification pay. Job Duties Maintain knowledge of federal regulations, institutional policies, and ICH GCP guidelines to guide regulatory staff and investigators in compliance. Confirm the content of regulatory submissions. Collaborate with regulatory staff and investigators on protocol documents and consent forms, and respond to queries from review committees and agencies like the FDA. Submit and maintain required documents. Assist in preparing for FDA meetings, inspections, and audits. Maintain systems to communicate regulatory changes and protocol-specific information to relevant parties. Ensure all clinical research projects remain compliant and are properly documented. Supervise a team of regulatory professionals. Perform additional duties as assigned. Minimum Qualifications Bachelor's degree. Four years of relevant experience. Preferred Qualifications Master's degree. Five years in regulatory affairs or compliance. Experience working with the FDA. Oncology, Cell, and Gene therapy experience. Project management skills. Strong computer and organizational skills. Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer. Additional Details Seniority level: Mid-Senior level Employment type: Full-time Job function: Research Industry: Higher Education Location: Houston, TX Salary Range: $103,000 - $139,000 Note: The job posting is recent and active. No indication of expiration is present. #J-18808-Ljbffr

The Director of Regulatory Affairs will lead Pano AI's engagement with utility regulators, public utility commissions (PUCs), and other key regulatory and policy stakeholders at the state and federal levels. This role focuses on shaping a favorable regulatory environment for wildfire detection technology and accelerating market adoption through strategic regulatory advocacy and collaboration with Pano's utility sales team. Pano AI is the utility sector leader in rapid detection and situational awareness this role is crucial to the company's continued growth in the sector.

This position is new and requires both strategic leadership and hands-on execution. Reporting to the VP for Global Government Affairs and working closely with the utility practice, it blends policy advocacy, regulatory strategy, stakeholder engagement, and business support, all aligned toward revenue growth and market transformation.

• Regulatory and Policy Strategy: Develop and execute a national and state-level regulatory strategy to promote the adoption of AI-enabled wildfire detection technology by electric utilities. Monitor, analyze, and engage with regulatory proceedings, dockets, and legislative developments relevant to wildfire mitigation, grid resilience, and rate recovery mechanisms. Advise internal leadership on emerging regulatory risks and opportunities affecting Pano's utility business.
• Advocacy and External Engagement: Build and maintain trusted relationships with public utility commissioners, regulatory staff, consumer advocates, trade associations, and other policy stakeholders. Lead preparation and submission of written comments, testimony, and filings in regulatory proceedings. Represent Pano AI at hearings, workshops, and conferences; participate in relevant industry working groups and coalitions. Position Pano as a thought leader on wildfire detection and grid resilience policy issues.
• Sales and Commercial Support: Act as a regulatory resource and partner to Pano's Utility Sales team during customer engagement, RFP processes, and negotiations. Provide strategic insights on cost recovery pathways, regulatory approval processes, and relevant policy drivers impacting utility purchasing decisions. Support sales teams with customer education materials, regulatory position papers, and responses to regulatory-related questions from utility clients.
• Cross-Functional Leadership: Work closely with Government Affairs, Product, Engineering, Legal, and Marketing to ensure regulatory trends and customer needs are integrated into product roadmaps and corporate strategy. Help develop public messaging and thought leadership content that advances Pano's policy objectives.

• 812+ years of experience in regulatory affairs, energy policy, utility operations, or related fields.
• Direct experience engaging with state Public Utility Commissions and/or federal energy regulators.
• Track record of successful regulatory advocacy, including comment filings, testimony, or policy wins.
• Experience working in or with investor-owned utilities, utility regulators, or technology vendors serving the utility sector.
• Strong knowledge of utility regulatory frameworks, including rate-making, cost recovery, and grid safety regulation. Direct experience in wildfire planning a plus.
• Excellent written and verbal communication skills; able to distill complex technical and policy topics into compelling, accessible narratives.
• Ability to develop trusted relationships with both regulatory bodies and commercial teams.
• High business acumen with a strong understanding of how regulatory issues drive revenue and market expansion.

• Familiarity with wildfire mitigation planning processes, PSPS protocols, etc.
• Experience working at a tech company serving the utility sector, for a Public Utility Commission, or within a utility's regulatory affairs team.
• Understanding of the intersection between AI/technology solutions and public safety infrastructure.
• Entrepreneurial mindset and comfort working in a fast-growing, mission-driven technology company.

$165,000 - $200,000 a year. Final salary offered is based upon multiple factors, including individual job-related qualifications, education, experience, knowledge, skills and location. In addition to salary, this position is also eligible for stock options. We offer comprehensive medical, dental and vision insurance, unlimited paid time off, and matching 401k.

Pano is an equal opportunity employer committed to recruiting and supporting our team-members regardless of where they come from. We do not discriminate on the basis of race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

Who we are The problem: Every minute matters in fire response. As climate change amplifies the intensity of wildfires—with longer fire seasons, dryer fuels, and faster winds—new ignitions spread faster and put more communities at risk. Today, most wildfires are detected by bystanders and reported via 911, meaning it can take hours to detect a fire, verify its exact location and size, and dispatch first responders. Fire authorities need a faster way to detect, confirm, and pinpoint fires so that they can quickly respond—preventing small flare-ups from becoming devastating infernos. About Pano: We are a 100+ person growth-stage hybrid-remote start-up, headquartered in San Francisco. We are the leader in early wildfire detection and intelligence, helping fire professionals respond to fires faster and more safely—with the right equipment, timely information, and enhanced coordination—so that they can stop a new ignition before it grows. Pano AI combines advanced hardware, software, and artificial intelligence into an easy-to-use, web-based platform. Leveraging a network of ultra-high-definition, 360-degree cameras atop high vantage points, as well as satellite and other data feeds, Pano AI produces a real-time picture of threats in a geographic region and delivers immediate, actionable intelligence. Pano AI is on TIME 's list of the 100 Most Influential Companies of 2025! MIT Technology Review listed Pano as one of the top 15 climate tech companies to watch in 2024, and Fast Company named Pano AI one of the Top 10 most innovative companies in AI of 2023 . We’ve also been featured in the Wall Street Journal , Bloomberg , and CNBC News . Pano AI’s dozens of government and enterprise customers span 16 states in the U.S., five states in Australia, and BC, Canada, and we are currently monitoring over 30 million acres of land. Pano AI has raised $89M in venture capital funding from Giant Ventures, Liberty Mutual Ventures, Tokio Marine Future Fund, Congruent Ventures, Initialized Capital, Salesforce Ventures, and T-Mobile Ventures. Learn more at . The Role The Director of Regulatory Affairs will lead Pano AI’s engagement with utility regulators, public utility commissions (PUCs), and other key regulatory and policy stakeholders at the state and federal levels. This role focuses on shaping a favorable regulatory environment for wildfire detection technology and accelerating market adoption through strategic regulatory advocacy and collaboration with Pano's utility sales team. Pano AI is the utility sector leader in rapid detection and situational awareness – this role is crucial to the company’s continued growth in the sector. This position is new and requires both strategic leadership and hands-on execution. Reporting to the VP for Global Government Affairs and working closely with the utility practice, it blends policy advocacy, regulatory strategy, stakeholder engagement, and business support, all aligned toward revenue growth and market transformation. What you’ll do Regulatory and Policy Strategy: 1.Develop and execute a national and state-level regulatory strategy to promote the adoption of AI-enabled wildfire detection technology by electric utilities. 2. Monitor, analyze, and engage with regulatory proceedings, dockets, and legislative developments relevant to wildfire mitigation, grid resilience, and rate recovery mechanisms. 3. Advise internal leadership on emerging regulatory risks and opportunities affecting Pano’s utility business. Advocacy and External Engagement: 1. Build and maintain trusted relationships with public utility commissioners, regulatory staff, consumer advocates, trade associations, and other policy stakeholders. 2. Lead preparation and submission of written comments, testimony, and filings in regulatory proceedings. 3. Represent Pano AI at hearings, workshops, and conferences; participate in relevant industry working groups and coalitions. 4. Position Pano as a thought leader on wildfire detection and grid resilience policy issues. Sales and Commercial Support: 1.Act as a regulatory resource and partner to Pano’s Utility Sales team during customer engagement, RFP processes, and negotiations. 2. Provide strategic insights on cost recovery pathways, regulatory approval processes, and relevant policy drivers impacting utility purchasing decisions. 3. Support sales teams with customer education materials, regulatory position papers, and responses to regulatory-related questions from utility clients. Cross-Functional Leadership: 1.Work closely with Government Affairs, Product, Engineering, Legal, and Marketing to ensure regulatory trends and customer needs are integrated into product roadmaps and corporate strategy. 2. Help develop public messaging and thought leadership content that advances Pano’s policy objectives. What you’ll bring 8–12+ years of experience in regulatory affairs, energy policy, utility operations, or related fields. Direct experience engaging with state Public Utility Commissions and/or federal energy regulators. Track record of successful regulatory advocacy, including comment filings, testimony, or policy wins. Experience working in or with investor-owned utilities, utility regulators, or technology vendors serving the utility sector. Strong knowledge of utility regulatory frameworks, including rate-making, cost recovery, and grid safety regulation. Direct experience in wildfire planning a plus. Excellent written and verbal communication skills; able to distill complex technical and policy topics into compelling, accessible narratives. Ability to develop trusted relationships with both regulatory bodies and commercial teams High business acumen with a strong understanding of how regulatory issues drive revenue and market expansion. Preferred Attributes Familiarity with wildfire mitigation planning processes, PSPS protocols, etc. Experience working at a tech company serving the utility sector, for a Public Utility Commission, or within a utility’s regulatory affairs team. Understanding of the intersection between AI/technology solutions and public safety infrastructure. Entrepreneurial mindset and comfort working in a fast-growing, mission-driven technology company. Final salary offered is based upon multiple factors, including individual job-related qualifications, education, experience, knowledge, skills and location. In addition to salary, this position is also eligible for stock options. We offer comprehensive medical, dental and vision insurance, unlimited paid time off, and matching 401k. Pano is an equal opportunity employer committed to recruiting and supporting our team-members regardless of where they come from. We do not discriminate on the basis of race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. #J-18808-Ljbffr

Direct message the job poster from Barrington James Seeking a Regulatory Affairs Contractor (Associate Director, Global Regulatory Affairs) based along the East Coast. In this role, you will contribute to the development and execution of regulatory strategy, support global submissions, and ensure compliance across all phases of drug development. This position requires strong collaboration with cross-functional teams and regulatory authorities, with a focus on advancing new drug development and commercialization. Key Responsibilities: Lead and implement regulatory strategy for assigned projects across all development phases. Prepare and manage INDs, CTAs, NDAs, MAAs, and related submissions. Collaborate with partners to align submission timelines and risk mitigation plans. Represent the company in meetings with regulatory agencies. Interpret scientific data in support of regulatory requirements and strategy. Provide leadership and guidance to cross-functional teams and global regulatory project teams. Support development of GRA processes and systems to improve efficiency. Qualifications: Bachelor’s degree in a scientific discipline (advanced degree preferred). 6+ years of Regulatory Affairs experience in drug development and registration (small molecule or biologics). Proven track record with global submissions (EU, international markets). Rare disease and pediatric drug development experience strongly preferred. Excellent communication, teamwork, and leadership skills. Strong project management and computer skills. Seniority level Seniority level Director Employment type Employment type Contract Job function Job function Project Management, Research, and Strategy/Planning Industries Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing Referrals increase your chances of interviewing at Barrington James by 2x Get notified about new Regulatory Affairs Consultant jobs in Boston, MA . Manager, Global Regulatory Affairs, Oncology Waltham, MA $134,250.00-$23,750.00 3 days ago Marlborough, MA 113,700.00- 189,400.00 3 days ago Associate Director, Global Regulatory Affairs Boston, MA 153,600.00- 241,340.00 1 day ago Manager, External and Regulatory Affairs Sr. Regulatory Affairs Specialist (Austin, TX) Burlington, MA 100,000.00- 110,000.00 1 week ago Senior Regulatory Affairs Specialist (IVD Exp. supporting US/Health Canada) Boston, MA 87,892.99- 118,774.78 2 weeks ago Associate Director, Regulatory Affairs Strategy Cambridge, MA 149,069.00- 223,604.00 2 months ago Cambridge, MA 114,000.00- 152,000.00 2 days ago Global Regulatory Affairs Operations and Planning Lead Cambridge, MA 250,000.00- 290,000.00 4 days ago Associate Director, Global Regulatory Affairs - GI & Inflammation Boston, MA 153,600.00- 241,340.00 2 weeks ago Associate Director, Global Regulatory Affairs – Global Labeling Strategy Cambridge, MA $1 7,000.00- 212,333.33 2 weeks ago Associate Director, Global Regulatory Affairs, CMC Small Molecules Boston, MA 153,600.00- 241,340.00 3 days ago Associate Director, Global Regulatory Affairs, Advertising and Promotion Associate Director, Regulatory Affairs, Advertising and Promotion Associate Director, Global Regulatory Affairs Boston, MA 153,600.00- 241,340.00 2 weeks ago Senior Principal, Regulatory Affairs - Companion Diagnostics Boston, MA 200,000.00- 240,000.00 2 days ago Senior Director, Global Regulatory Lead, GI & Inflammation Associate Director, Global Regulatory Affairs - GI & Inflammation Associate Director, Global Regulatory Affairs, CMC Small Molecules We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr

Responsibilities Develop global regulatory strategies for medical device products to meet business objectives and collaborate across a matrixed organization to ensure global success of products registration. Participate on product development teams, providing regulatory strategies, timelines, and direction. Reviews and approvals of technical documentation. Negotiate with regulatory authorities to resolve questions/issues that arise during the product lifecycle. Drive product change assessments and define the regulatory impact of product changes in global markets. Review and approve labeling, training, promotional, and advertising material. Maintenance of Regulatory Affairs product files and ensure compliance with regulatory requirements. Participate on audit and field action teams as well as support other post-market activities. Facilitate and prepare U.S. regulatory Pre-Submission documents and pre submission meetings Regulatory experts support IVDR teams, implements regulatory strategies for IVDR activities; provides regulatory leadership; collaborates with the regulatory staff from other business units, companies, and government agencies as needed to develop harmonized policies, procedures, and work instructions for IVDR compliance. Prepares documents vital for new product market clearance, approval, and continuance during product life cycle management that includes (but is not limited to) 510(k)s, PM, De Novo, and technical files for CE marking. Support global regulatory registration representatives for product global registration activities Keep abreast of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc. Conduct training and/or communicate appropriate materials, as needed, to enhance the team's knowledge of working in a regulated environment. Assist the Regulatory department in the update, improvement, and creation of internal policies and procedures. Participate in business meetings with external partners as needed. Participates in inspections/audits by the notified body or other international regulatory bodies by producing requested documents or answering any inquiries for information. Requirements A minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science. Must have a minimum of 5 years of IVD Regulatory Affairs experience. This experience must include 510(k), De Novo, PMA, PMA supplement submissions. Experience as the RA representative on project core teams providing active and successful regulatory guidance and RA strategies. Excellent knowledge of U.S. and European/International regulations and standards. RAPS' Regulatory Affairs Certification (RAC). Experience interacting with FDA and/or other regulatory agencies. Experience reviewing design specifications and other technical documents. Previous experience in EU MDD/IVDD or MDR/IVDR. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. #J-18808-Ljbffr