div class="content-intro">Baltimore, MD30+ days ago
li> Provide leadership to Subject Matter Experts (SMEs) in multidisciplinary teams and manage day to-day operations of project tasks/activities to ensure deliverables are met in a timely manner within budget. Experience with multiple electronic software/platforms (such as Vantagepoint, Starting Point templates (or similar regulatory templates), Smartsheet, MS Office suite or other project management programs).
Our scientific/regulatory consulting team is expanding, and we are seeking a mid-level experienced scientific professional with a strong CMC Regulatory Affairs background to join our team of experienced professional consultants. We offer a congenial, supportive, and flexible work environment, the opportunity to work with knowledgeable consultants, and the ability to develop a tremendous amount of knowledge and expertise across many stages and areas of healthcare product development.
Our history spans over 200 years and today we are a leader in investment banking, consumer and small business banking, commercial banking, financial transaction processing and asset management. JPMorgan Chase, one of the oldest financial institutions, offers innovative financial solutions to millions of consumers, small businesses and many of the world's most prominent corporate, institutional and government clients under the J.P.
Fort Detrick, MD30+ days ago
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. Summary: The Regulatory Affairs Manager V will work products related to the development and management of regulatory affairs strategic planning and guidance within current and planned vaccine, therapeutic, and/or device/diagnostic advanced development and acquisition contracts.
With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. Serve as the primary contact with the FDA's Office of Prescription Drug Promotion (OPDP) within the U.S. Food and Drug Administration; lead submissions, risk mitigation strategies, and regulatory interactions including advisory comments, Form FDA 2253 submissions, and responses to regulatory enforcement actions.
Arlington, VA30+ days ago
p>Qualifications: • 10+ years in satellite policy, regulatory affairs, or telecom law within the satellite or aerospace sector • Strong network of relationships across government agencies, space industry bodies, and regulatory institutions • Deep knowledge of FCC and ITU frameworks and procedures • Knowledge of orbital debris mitigation policy and space sustainability frameworks • Strong experience reporting to executive teams and boards, including preparation of regulatory or strategy briefings • Demonstrated success leading teams and working cross-functionally • Track record of representing organizations at high-level international policy forums (e.g., WRC, UN COPUOS) • Willingness to travel approximately 25% of the time.
Preferred Skills & Experience:
• Leadership experience with global satellite operators, launch providers, or legal/regulatory advisory firms • MBA, MSEE, JD, or equivalent advanced degree in a related field • Technical expertise in RF engineering, satellite systems, and/or inter-satellite links • Experience with spectrum requirements for commercial space launch, lunar operations • Background in national security space policy and ITAR/EAR compliance • Proven ability to navigate complex multi-stakeholder regulatory challenges • Experience leading through organizational growth and transformation.
Advancing company positions in preparation for and on U.S. delegations to spectrum-related international conferences and meetings (e.g., ITU WRCs and Study Groups, CITEL PCC II, and related preparatory meetings), and in trade association discussions. For specific work locations within San Jose, the San Francisco Bay area, and New York City metropolitan area, the base pay range for this role is $242,500.00- $363,500.00/ annually.
Washington, District of Columbia16 days ago
The Director will serve as a key connector across Government Affairs, business leaders, and subject matter experts to inform decision-making and drive effective engagement with federal agencies. The Director of U.S. Regulatory Affairs is a strategic leader responsible for providing expert regulatory guidance to support the development and execution of public policy initiatives and federal agency engagement strategies.
Washington, District of Columbia17 days ago
The primary roles and responsibilities include managing the development of regulatory submissions, development of overall regulatory strategy, communicating with regulatory bodies and clients, and leading or expanding new therapy ideas, as applicable. Develop and execute regulatory services for client companies, including however not limited to:
Regulatory Submissions (e.g., 510(k), IDE, PMA, IND, BLA, & IND, Technical Documentation, STED, CERs).
GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment.
p>As a Government Affairs Director, Spectrum Policy & Regulatory Affairs you will be responsible for: Developing and implementing spectrum policy and regulatory positions in support of MSI business goals and objectives, coordinating MSI spectrum and regulatory strategies between different regulatory regimes, balancing the differences in spectrum availability and regulations between countries to advance MSI interests.
Represent MSI externally at regional and international spectrum conferences such as the World Radio Conference, and at industry, public safety and other trade association conferences and meetings (e.g., TIA, EWA, IWCE, APCO) acting as the face of MSI on such issues.
Washington, DC16 days ago
We collect and use those categories of Personal Information about you for human resources and other business management purposes, including identifying and evaluating you as a candidate for potential or future employment or future positions, recordkeeping in relation to recruiting and hiring, conducting analytics, and ensuring compliance with applicable legal requirements and Company policies. Work with the latest technologies: You'll gain exposure to a broad spectrum of IoT, SaaS and machine learning obstacles, including distributed fault-tolerance, device control optimization, and process modeling to support scalable interaction with disparate downstream APIs.
Washington, DC24 days ago
ul>Higher-education regulatory affairs: - Manage state authorization across all jurisdictions where students are located, including renewals and reporting with the DC Higher Education Licensure Commission (HELC), the California BPPE, the Alabama Commission on Higher Education (ACHE), and NC-SARA.
- Track federal rulemaking affecting higher education, both during the negotiated rulemaking phase, where stakeholder coordination shapes the proposed rule, and through the NPRM, comment, and final rule phases, and translate outcomes into operational requirements for the business.
Washington, District of Columbia30+ days ago
p style="min-height:1.5em">Learn more about our vision, team, and backers athttps://www.emeraldai.co/. Preferred style="min-height:1.5em">Experience working with or before state Public Utility Commissions and/or the Federal Energy Regulatory Commission (FERC).
Washington, DC30 days ago
By attracting, supporting, promoting and retaining highly qualified individuals of various backgrounds and experiences, they strengthen the ability to provide innovative solutions, deliver exceptional client service, and advance the success of their Firm. Expected responsibilities will include, but will not be limited to:- Supporting the our client's Federal Public Policy team of on all their clients and projects related to natural resources and water policy issues, tracking developments on legislation and regulations, and advising on related strategy.
Germantown, MD25 days ago
This role is responsible for defining regulatory strategy, planning and the preparation of US and eventually global regulatory submissions to achieve timely approvals of biologic licensing and marketing authorization applications and post-approval lifecycle changes for Precigen CAR-T and AdenoVerse immunotherapy Products. We are seeking a global Executive Director, Regulatory Affairs (level determined by candidate experience) reporting into the SVP Regulatory Affairs who is responsible for oversight of IND/IMPD, BLA and ex-US activities for the CAR-T and immunotherapy products.
Gaithersburg, MD8 days ago
Partnering with senior leaders and global teams, you will lead strategy across key milestones-from expedited designations and Health Authority interactions through major submissions and post-approval maintenance-helping the business deliver transformative therapies at pace and with rigor. In this Director role, you will shape the regulatory path for programs that span oncology, immune-mediated and rare diseases-translating breakthrough science into timely approvals and competitive labeling that make a tangible difference to patients and markets.