1,390 Results for

Regulatory Affairs Jobs in Washington, DC

Jobs

Washington, DC

$40–$45 / hour

p>Download the Sparks Group mobile app from Apple App Store or Google Play..

We offer several comprehensive benefits package including health and life insurance, paid and unpaid time off, and retirement and savings plans to qualifying employees..

11 days ago

Bethesda, MD

$88,000–$163,000

Our passionate, global workforce augments local expertise and diverse mix of skills with data, science, and technology to deliver bespoke engagement solutions that help clients reimagine how they engage with their patients, payers, people, and providers to improve treatment outcomes.

Job Description

Inizio Engage has a long-standing partnership with a leading biotechnology organization across Commercial, Patient Solutions and Medical Affairs businesses.

Today

Sriracha, CHO

li>Ensure LRN is updated with new employee information for new hires, delete terminated employees, make sure all employees are compliant with training requirements by due date and train employees in a classroom setting for those that do not have email addresses.

Full spectrum of Payroll management function such as collect & checking data, payroll processing, payment and summary report (Month-End, Year-End, Tax, Social Security Fund, etc.).

30+ days ago

Washington, DC

$260,000–$310,000 / year

div>Regulatory & Government Affairs Practice Group

Location: Washington, DC preferred

Other Locations Available – full list at the bottom of this description..

Interested candidates should submit a cover letter indicating their preferred office location, resume, and law school transcript for consideration.

5 days ago

Rockville, MD

$190,800–$300,300 / year

p>Required Skills:

Corporate Commercial, Cross-Cultural Awareness, Drug Development, Exercises Judgment, Global Health, Global Market, Healthcare Innovation, Interpersonal Relationships, In Vitro Diagnostics (IVD), Multiple Therapeutic Areas, Oral Communications, Orphan Drugs, Pharmaceutical Regulatory Affairs, Process Improvements, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Issues, Regulatory Management, Regulatory Strategy Development, Written Communication. As the Global Regulatory Lead (GRL), the Senior Principal Scientist functions as the regulatory single, accountable, global point of contact on the project team and interacts with the global regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more company investigational and marketed drugs/biologics in early- and/or late-stage development.

30+ days ago

You will also partner with teams across Google and Alphabet's Public Policy, Compliance, Legal, Engineering, Finance and product areas to support the handling of some of the most important issues for the company today.

In this role, you will work closely with members of Regulatory Affairs and act as the central operations support for the department"s role in the broader regulatory lifecycle.

22 days ago

Herndon, VA

Remote

$50,000–$80,000 / year

p>The ideal candidate will have the following:

• Bachelor's degree, in a relevant scientific discipline (e.g., biology, chemistry, biochemistry, clinical research, etc.) or equivalent relevant scientific/regulatory/quality experience, is required. 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.

30+ days ago

McLean, VA

$131,300–$149,800 / year

GEA teams include Regulatory Affairs, Risk, Innovation, Strategy and Enablement (RISE), Community Impact and Investment (CII), Community Finance, CRA Strategy and Program Management, Global Policy Affairs Group (GPAG), and Global Enterprise Communications (GEC). This associate will provide support to the Regulatory Affairs tower within GEA by executing, collaborating on and leading (as appropriate) substantive and significant projects and ongoing activities related to project delivery, team enablement and providing associates with a rewarding experience.

25 days ago

District of Columbia

Reporting to the Head of Government Affairs, this individual will play a critical role in advancing Broadridge's policy priorities by building and maintaining relationships with key federal officials, monitoring legislative and regulatory developments, and positioning Broadridge as a trusted resource among policymakers and industry stakeholders.

The ideal candidate brings deep knowledge of the financial services regulatory landscape, a strong network on Capitol Hill and within federal agencies, and the ability to translate complex regulatory issues into clear, compelling narratives for a variety of audiences.

30+ days ago

Rockville, MD

$138,750–$231,250 / year

This role will ensure the development of appropriate global and/or regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy /Integrated Asset plan to ensure the development program meets the needs of the key markets identified and the Medicines Profile. Work with the Early/Medicine Development Team (EDT/MDT) or GRL, to ensure a robust regulatory strategy is in place to support the development program to meet the needs of the key markets identified in the Integrated Asset plan and the Medicine Profile.

6 days ago

$180,000–$190,000 / year

30+ days ago

Gaithersburg, MD

$218,058–$327,087 / year

p>Accountabilities:

Global Regulatory Leadership: Own the end-to-end global regulatory strategy for a high-complexity cell and gene therapy program, from current stage through BLA submission, ensuring an efficient route to approval with competitive labeling aligned to product attributes and patient, market and business needs.

Cross-Functional Product Leadership: Represent Regulatory Affairs on Global Product Teams, shaping development and commercialization plans, contributing to governance presentations and aligning regulatory objectives with clinical, CMC, safety and commercial strategies.

9 days ago

$150,000–$215,000 / year

p>RESPONSIBILITIES:

• Assist with developing and advocating for broadband and spectrum policies that will further SpaceX's business objectives and Starlink's success domestically and internationally • Draft pleadings, letters, and other advocacy pieces to promote SpaceX's policy positions • Contribute to company satellite spectrum policy and outreach activities with government officials at all levels • Represent and promote the company positions before the FCC, the NTIA, and other Federal agencies, regulators, legislatures, and regional organizations • Direct regulatory practice to secure necessary U.S. licenses, regulatory compliance, and customer support for all SpaceX spacecraft, earth stations, and services for the Starlink program • Develop and administer regulatory licensing application preparation, pursuit, and compliance requirements for system and service licensing • Provide strategic regulatory advice and advocacy support to business development efforts • Advocate to optimize prospective satellite and telecoms regulatory frameworks and policy environments in alignment with SpaceX business objectives.

PREferred SKILLS AND EXPERIENCE:

• Bachelor's or master's degree in an engineering, math, chemistry, or physics discipline • Understanding of broadband policy • Understanding of spectrum use and policies • Knowledge of radiofrequency spectrum technology • Knowledge of telecommunications business and regulatory issues outside of the U.S. • Experience working with the Federal Communications Commission and other federal agencies • Knowledge of key commercial and government players in the telecommunications/broadband industry • Experience at a well-regarded law firm • Experience as an in-house lawyer ideally within the tech industry • Diligent and proactive, you have demonstrated excellent legal and business judgment, technical acumen, communication skills and strategic thinking, along with the ability to work independently and cross-functionally.

30+ days ago

Germantown, MD

Participation in project team and sub team discussions regarding preclinical, clinical and CMC aspects of drug development, providing regulatory guidance, communicating regulatory goals and timelines, and helping to ensure compliance to the requirements from U.S. and foreign regulatory agencies. The Associate Director/Senior Manager will interact with all aspects of Precigen's quality, CMC, preclinical, and clinical drug development programs, policies, and procedures ensuring compliance is maintained with all regulatory commitments/requirements.

26 days ago

Gaithersburg, MD

$135,624.80–$203,437.20 / year

The Associate Regulatory Affairs Director, US Lead, Regulatory Science & Execution will be accountable for the development, implementation and maintenance of regulatory strategies for assigned project(s)/product(s) and regulatory jurisdiction(s), with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs. Providing strategic and tactical advice on regulatory issues for pipeline products; actively collaborates with management, Global Regulatory Lead, and cross functional colleagues within Alexion (i.e., commercial, research, clinical development, medical affairs, business development, legal, manufacturing, quality, portfolio management, financial, human resources, etc.).

24 days ago

Arlington, VA

Remote

$99,500–$130,000 / year

If you live within 50 miles of our Arlington, VA, headquarters, this will be a hybrid position currently requiring Tuesday-Thursday onsite This will support International Premium Waters Position Summary Apply experience and expertise of regulations & policies to review and apply compliance by design of (a) formulas, ingredients and any relevant processing procedures, (b) all required and optional label information, including claims, and (c) sensitive communications such as advertising, promotional materials, websites, etc. Must demonstrate strong verbal and written communications skills, along with strong influencing and negotiation skills, recognized expertise in functional areas with the ability to communicate regulatory and technical issues in lay terms.

30+ days ago

Columbia, MD

$101,500–$152,250 / year

p>The Senior Regulatory Affairs Specialist will be responsible for projects by leading regulatory submissions and designing comprehensive regulatory strategies on Human Cells, Tissues, and Cellular and Tissue-Based products (HCT/P) projects as well as define regulatory strategies for new device-led combination products.

Inclusion and Belonging- Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/).

30+ days ago

Washington, WA

$248,000–$310,000 / year

Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more. This role combines senior‑level regulatory policy leadership, regulatory intelligence, and external advocacy, with accountability for shaping US regulatory outcomes, enabling development and portfolio strategy, and strengthening Teva's influence and credibility with FDA and key stakeholders.

30+ days ago

Montgomery County, MD

$121,785–$158,322 / year

In addition, to qualify for a Regulatory Affairs Specialist GS-0601 position at the GS-13 grade level, you must have: at least one (1) year of qualifying experience equivalent to at least the GS-12 level in the Federal service obtained in either the private or public sector, performing the following types of tasks: (1) Leading protocol navigation activities, including coordinating scientific review, Institutional Review Board (IRB) and/or Investigational New Drug (IND) submissions, addressing stipulations, and facilitating clinical trial protocol development processes; (2) Managing a clinical trials portfolio by liaising with investigators/ study teams, regulatory agencies, and sponsors; tracking reviews of all review bodies; and maintaining accurate essential regulatory documentation; (3) Developing regulatory documents such as protocols, consents, and associated components in accordance with federal regulatory requirements; (4) Providing regulatory expertise by analyzing complex issues, preparing safety, annual, and/or progress reports, and recommending strategies to ensure compliance and expedite review processes. Assist all aspects of the protocol lifecycle including scientific review, initial investigational new drug (IND) documents, institutional review board (IRB) submission of protocols, continuing review applications, protocol amendments, annual reports to other regulatory and safety bodies such as the Radiation Safety Committee (RSC) and the Institutional Biosafety Committee (IBC), and protocol inactivation.

24 days ago

Gaithersburg, MD

Desirable Skills/Experience: • Advanced degree in life sciences, pharmacy, law, or a related discipline • 10 or more years of experience in US promotional regulatory affairs within biopharma, including direct OPDP/APLB interactions and resolution of advisory or enforcement matters • Experience leading or co-chairing MLR processes and operating within digital review systems such as AZAP or comparable platforms • Launch-to-lifecycle leadership across HCP and consumer promotions, managed markets materials, and omnichannel/digital campaigns • Proven ability to design and deliver effective regulatory training for commercial and medical stakeholders • Demonstrated influence at senior levels to shape departmental practices and operational plans • People leadership experience with a track record of coaching and building high-performing teams. Essential Skills/Experience: • Bachelor's degree in science • 3+ years' experience in promotional regulatory affairs, FDA (OPDP/APLB), or other equivalent experience in advertising and promotion review • 5+ years total experience in pharmaceutical/biotech industry, FDA, or equivalent experience • Strong knowledge of FDA promotional regulations and ability to apply such knowledge in review of diverse promotional materials and audiences • Knowledge of the drug development and labeling processes.

30+ days ago

Gaithersburg, MD

$178,534–$267,801 / year

p>Competitive salary and benefits package on offer:

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles).

30+ days ago

Gaithersburg, MD

$186,232.80–$279,349.20 / year

p>Competitive salary and benefits package on offer:

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. The more experienced you are, the more accountability you will have for strategic leadership including responsibility for development and implementation of the global regulatory strategy for a product/group of products of increasing complexity.

30+ days ago

Gaithersburg, MD

$135,624.80–$203,437.20 / year

p>The Associate Regulatory Affairs Director, US Lead, Regulatory Science & Execution will be accountable for the development, implementation and maintenance of regulatory strategies for assigned project(s)/product(s) and regulatory jurisdiction(s), with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs.

Providing strategic and tactical advice on regulatory issues for pipeline products; actively collaborates with management, Global Regulatory Lead, and cross functional colleagues within Alexion (i.e., commercial, research, clinical development, medical affairs, business development, legal, manufacturing, quality, portfolio management, financial, human resources, etc.).

16 days ago

Rockville, MD

p>US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position.

11 days ago

Gaithersburg, MD

$276,127–$414,190 / year

p>Milestone Delivery and Dossier Excellence: Be accountable for delivery of all project-related regulatory milestones, including probability of regulatory success assessments, mitigation planning, approval strategy, lifecycle planning; lead preparation of regulatory strategy documents and target product labeling; ensure strong strategic planning and construction of the global dossier and core prescribing information; oversee maintenance and compliance for marketed brands where applicable.

Accountabilities:

Global Regulatory Strategy Leadership: Own the end-to-end global regulatory strategy for a cell and gene therapy product or franchise of exceptional complexity and strategic importance, from current stage through BLA submission, approval, and lifecycle management; may serve in a dual role as Franchise GRL and regional Regulatory Affairs Director.

10 days ago

Gaithersburg, MD

$157,500–$262,500 / year

p>Experience & knowledge Essential:

• Solid track record in drug development and leadership within a dynamic project team • Emerging understanding of global regulatory requirements to be able to formulate tactical regulatory strategies • Ability to prepare and submit regulatory documentation to ensure regulatory compliance globally • Emerging ability to propose scientific regulatory strategies that are reviewed with line management for concurrence and approval • Excellent knowledge of US regulatory requirements and experience with submissions gained within drug development.

The individual will also be assigned projects and regulatory activities by providing expertise to Immunocores development programs to include regulatory implementation of regulatory strategies, IND developments, submission, maintenance, tracking BLAs, BLA planning, submission, maintenance, tracking agency liaison for specific tactical assignments and regulatory intelligence for tactical process-related changes in requirements.

30+ days ago

Rockville, MD

$100,000–$140,000 / year

p>Supernus Pharmaceuticals is an award-winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that treat central nervous system (CNS) diseases. The worker is required to have close visual acuity to perform an activity such as preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading.

30+ days ago

Germantown, MD

Create practical solutions to complex regulatory challenges by setting policies and procedures, aligning cross-functional teams, and maintaining strong working relationships with government and non-government organizations that affect market access and distribution.

Strategic experience and ability, having demonstrated success related to the development and implementation of pre-clinical and clinical strategies for clinical IVD products, implementation of regulatory systems, and assuring compliance to all applicable regulations.

30+ days ago

Gaithersburg, MD

$109,245–$163,867 / year

li>Integrated Project Management: Develop, execute and maintain submission delivery plans and content plans; proactively provide status updates to stakeholders; coordinate input, maintenance and revisions in Planit project plans; highlight unforeseen changes in resource demand to the Lead RPM and line manager.

Submission Leadership: Lead and contribute to planning, preparation (including authoring where relevant) and delivery of simple and, with experience, increasingly complex submissions throughout the product lifecycle from global and/or regional perspectives; connect immediate deliverables to future label and lifecycle opportunities.

5 days ago

$99,000–$157,000 / year

p>The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

• Lead global regulatory intelligence initiatives, contribute to regulatory and product registration strategies, and help implement global regulatory roadmaps based on the competitive landscape and marketing objectives.

30+ days ago

Gaithersburg, MD

$295,600–$347,764 / year

p>Your Role:

The role will be responsible to lead the regulatory strategy for US Biomedicine efforts in alignment with global efforts.?The role will oversee industry-specific practices, ensure all government and company regulations are being met, assessing regulatory risks and interfacing with regulatory authorities to ensure the company meets all set requirements and guidance's.
Lead team members that provide regulatory affairs content and requirements for regulatory submissions and review this content for conformance with established requirement.?Manage and develop staff, if required, including staff professional development and project oversight accountability.?.

26 days ago

Rockville, MD

$113,850–$189,750 / year

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.

6 days ago

Washington, District of Columbia

p>The Vice President, MedTech Cardiovascular Regulatory Affairs will be a critical team member and Company leader supporting regulatory strategy and submissions for the firm’s clientele, and managing and leading their domain specific department, as required.

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) Regulatory Strategy, Analysis & Development.

30+ days ago

Washington, DC

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Tunnell Government Services, Inc., is comprised of the industry's leading scientists, medical and technical experts, and human capital and organizational development professionals. For more information on BARDA please visit their website at: https://aspr.hhs.gov/AboutASPR/ProgramOffices/BARDA/Pages/default.aspx and specifically the Division of Regulatory and Quality Affairs: https://medicalcountermeasures.gov/barda/rqa.

20 days ago

Baltimore, MD

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).

30+ days ago

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.

30+ days ago

Herndon, VA

Remote

$115,000–$215,000 / year

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.

18 days ago

Washington, District of Columbia

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.

17 days ago

$242,500–$363,500 / year

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.

30+ days ago

$151,000–$314,000 / year

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.

30+ days ago

Arlington, VA

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.

30+ days ago

Washington, District of Columbia

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).

18 days ago

Rockville, MD

$113,850–$189,750 / year

6 days ago

$220,000–$230,000 / year

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.

30+ days ago

Washington, DC

$24–$25 / hour

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.

17 days ago

Washington, DC

$100,000–$125,000 / year

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.

30+ days ago

Annandale, VA

p>HJF is seeking a Regulatory Affairs Specialist-WHIRC to be responsible for assisting in the compliance of HJF research programs with applicable local, state and federal regulations for human subjects' research, animal use research, recombinant DNA, and Health Insurance Portability and Accountability Act (HIPAA).

We serve military, medical, academic and government clients by administering, managing, and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike.

30+ days ago

Germantown, MD

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.

26 days ago

Washington, DC

$235,000–$285,000

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.

25 days ago

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Regulatory Affairs Jobs in Washington, DC

Technical Writer Sparks Group

Clinical Educator Inizio Engage

Human Resources Manager Shred-Tech Asia Co., Ltd.

Associate Attorney - National Security & Global Trade - Multi Office Gables Search Group

Senior Director Regulatory Affairs Liaison- General Medicine Merck & Co Inc

Strategy and Operations Lead, Regulatory Affairs Google LLC

CLINICAL DEVELOPMENT & REGULATORY AFFAIRS ASSOCIATE (ENTRY LEVEL) SciLucent LLC

Principal Associate, Chief of Staff - Regulatory Affairs Capital One Financial Corp

Director, Government & Regulatory Affairs (Hybrid - Washington D.C.,) Broadridge

Associate Director Regulatory Affairs, Oncology GSK plc

Director, Government & Regulatory Affairs (Hybrid - Washington D.C.,) Broadridge Financial Solutions Inc

Senior Director, Regulatory Affairs Strategy - Cell and Gene Therapy AstraZeneca Plc

Satellite Policy Associate Starlink Regulatory Affairs Space Exploration Technologies Corp

Associate Director/Senior Manager Regulatory Affairs Precigen Inc

Associate Director, Regulatory Affairs US Lead, Regulatory Science & Execution AstraZeneca Plc

Senior Regulatory & Scientific Affairs Specialist (Remote) Nestle SA

Senior Regulatory Affairs Specialist (Columbia, MD) Smith & Nephew Plc

Senior Director, Head of US Regulatory Affairs Policy & Intelligence Teva Pharmaceutical Industries Ltd

Regulatory Affairs Specialist US Department of Health and Human Services

Director Promotional Regulatory Affairs AstraZeneca Plc

Regulatory Affairs Director AstraZeneca Plc

Regulatory Affairs Strategy Director AstraZeneca Plc

Associate Director, Regulatory Affairs US Lead, Regulatory Science & Execution Alexion Pharmaceuticals Inc

Senior Manager Regulatory Affairs US Advertising and Promotion - Immunology AbbVie Inc

Executive Director, Regulatory Affairs Strategy - Cell and Gene Therapy AstraZeneca Plc

Director of Regulatory Affairs,Tactical and Implementation Immunocore Holdings Plc

Manager, Regulatory Affairs - Advertising and Promotion Supernus Pharmaceuticals Inc

Vice President, Global Head of Regulatory Affairs Qiagen NV

Regulatory Affairs Manager AstraZeneca Plc

Senior Regulatory Affairs Specialist Philips

Vice President, Regulatory Affairs *PC 884 Miltenyi Biotec GmbH

Strategy Lead, CMC Mature, Regulatory Affairs GSK plc

Vice President, MedTech Cardiovascular Regulatory Affairs IQVIA

Sr. Regulatory Affairs Analyst - Medical Devices Tunnell Government Services

Regulatory Affairs Manager Katalyst Healthcares & Life Sciences

Executive Director, Regulatory Affairs JPMorgan Chase & Co

CMC REGULATORY AFFAIRS CONSULTANT (SENIOR-LEVEL) SciLucent LLC

Director - US Regulatory Affairs Fresenius Medical Care

Associate General Counsel, U.S. Government Affairs and Regulatory ViaSat Inc

Head of US Regulatory Affairs Advertising and Promotion Viatris Inc

Director of Regulatory Affairs, Satellite Policy Blue Origin Enterprises LP

Director, Regulatory Affairs - Neurology MedTech IQVIA

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).

Regulatory Submissions (e.g., 510(k), IDE, PMA, IND, BLA, & IND, Technical Documentation, STED, CERs).

Manager, CMC Vaccines Mature Projects, Regulatory Affairs GSK plc

Government Affairs Director - Global Spectrum Policy & Regulatory Affairs Motorola Solutions Inc

Regulatory Affairs Intern EnergyHub

Regulatory, Public Policy, and Government Affairs Associate Managing Director Graham Inc.

Regulatory Affairs Specialist - WHIRC The Henry M Jackson Foundation for the Advancement of Military Medicine Inc

Executive Director, Regulatory Affairs Precigen Inc

General Counsel & Head of Regulatory Affairs Quantic School of Business and Technology

Resume Resources

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).