Director, Research & Development StarKist Co.Director, Research & DevelopmentReston, VAFull timeResponsible for the communication of new and base business activities and strategies with non-technical areas such as Marketing & Innovation, Trade Marketing, Market Research, Finance, and Sales. Act as the liaison between the non-technical areas as well as the technical areas to develop and execute new and base products and process strategies to grow the overall business and enable cost savings.
Quality Engineer CYNET SYSTEMSQuality EngineerColumbia, MD$47–$52 / hourTemporaryContractorPart timeWe deliver agile, scalable talent solutions across IT, engineering, life sciences, clinical, and professional staffing, powered by a high-performing recruitment engine operating across North America and Asia. As a nationally and locally certified Minority Business Enterprise (MBE), Cynet Systems is committed to helping organizations build high-performing teams while empowering professionals to grow rewarding careers.
ISSO Security Analyst, Senior AASR American Management Group, LLC (AMG)ISSO Security Analyst, Senior AASRManassass, VirginiaFull timeAs a Security Analyst on our team, you’ll use your experience to work with Veterans Affairs (VA) Information System Owners (ISO), Information System Security Officers (ISSO), site managers, and other system stakeholders to coordinate and drive the completion of Risk Management Framework (RMF) steps 0-6 ATO activities and requirements, identify and mitigate risks, escalate project risks to leadership, understand and apply VA authorization policies and processes, and provide information system security expertise. Nice If You Have: Experience with Continuous Authorization and Monitoring (CAM) Experience working with the VA Experience supporting ATOs for specialized devices Ability to engage with varying levels of staff and leadership Possession of excellent verbal and written communication skills .
ISSO Security Analyst, Senior SESR American Management Group, LLC (AMG)ISSO Security Analyst, Senior SESRManassass, VirginiaFull timeAs a Security Analyst on our team, you’ll use your experience to work with Veterans Affairs (VA) Information System Owners (ISO), Information System Security Officers (ISSO), site managers, and other system stakeholders to coordinate and drive the completion of Risk Management Framework (RMF) steps 0-6 ATO activities and requirements, identify and mitigate risks, escalate project risks to leadership, understand and apply VA authorization policies and processes, and provide information system security expertise. Nice If You Have: Experience with Continuous Authorization and Monitoring (CAM) Experience working with the VA Experience supporting ATOs for specialized devices Ability to engage with varying levels of staff and leadership Possession of excellent verbal and written communication skills The hourly rate of pay for this position is $73.89/hr.
Head Of US Regulatory Affairs Advertising And Promotion, Global Regulatory Affairs Viatris Inc.Head Of US Regulatory Affairs Advertising And Promotion, Global Regulatory AffairsWashington, DC$151,000–$314,000 / yearWith 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.
Senior Director Regulatory Affairs Liaison- General Medicine Merck & Co IncSenior Director Regulatory Affairs Liaison- General MedicineRockville, MD$190,800–$300,300 / yearRequired 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.
Manager, Regulatory Affairs, Regulatory PMO Google LLCManager, Regulatory Affairs, Regulatory PMOWashington D.C., DCOversee and lead a team partnering with legal counsel, product teams, and other cross-functional stakeholders to drive strategy, share information, and implement program management principles across our largest and most complex matters (including litigation, internal investigations, and regulatory requests). Lead the development of project, program, and portfolio management methodologies, identifying opportunities for cross-organizational process improvement initiatives and knowledge management projects.
Associate Director, Promotional Regulatory Affairs AstraZeneca PlcAssociate Director, Promotional Regulatory AffairsGaithersburg, MD$150,098–$225,147 / yearAs the Associate Director Promotional Regulatory Affairs, you will ensure efficient and effective regulatory review and risk assessment of promotional material for all segments (HCP, Consumer, Managed Markets) and media (Print, broadcast and electronic), sales training, faculty training, Proactive Scientific Exchange by SciP, Corporate Affairs communications, and any other materials required to be reviewed through AZAP. The Associate Director Promotional Regulatory Affairs will work with a with a cross-functional review team and provide regulatory guidance and risk assessment to help business teams develop and deliver initiatives that are intended to comply with applicable laws, rules and regulations governing the advertising and promotion of pharmaceutical products in the US.
Director, Government & Regulatory Affairs (Hybrid - Washington D.C.,) BroadridgeDirector, Government & Regulatory Affairs (Hybrid - Washington D.C.,)District of ColumbiaReporting 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.
Sr. Regulatory Affairs Specialist VB SpineSr. Regulatory Affairs SpecialistLeesburg, VirginiaAt VB Spine, join a high-performing team where you’ll play a significant role in bringing innovative spinal technologies to market while ensuring full regulatory compliance — positioning yourself for continued growth in a dynamic, mission-driven medical device company. The typical pay range for this position is $100,000.00 - $105,000.00 annually, with potential for bonuses and incentives plus benefits.
Senior Regulatory Affairs Director AstraZeneca PlcSenior Regulatory Affairs DirectorGaithersburg, MD$218,058.40–$327,087.60 / yearOptional: May be accountable for leadership of regulatory operational activities from planning to submission of regulatory applications and HA interactions, providing regulatory expertise and advice on procedural and documentation requirements to product teams and execution submission delivery plans across all regions. Lead the planning and construction of the global dossier and core prescribing information, conduct regulatory risk planning and mitigation, and lead the Global Regulatory Sub-team (GRST) with key contributing members from a regional perspective, emerging markets, RA CMC as well as delivery & enablement.
Associate Director Regulatory Affairs, Oncology GSK plcAssociate Director Regulatory Affairs, OncologyRockville, MD$138,750–$231,250 / yearThis 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.
NewSenior Manager, Regulatory Affairs - International Advocacy Capital OneSenior Manager, Regulatory Affairs - International AdvocacyMcLean, Virginia6+ years of experience architecting and executing international policy advocacy strategies, with a proven track record of directly engaging international regulatory bodies, government officials, and industry trade groups to shape evolving regulatory frameworks and advance strategic business priorities. Shaping and executing Capital One’s international policy advocacy development by drafting policy papers, briefing notes, position papers and advocacy products on relevant issues in close coordination with other internal functions (Government Affairs), inclusive of new market entry readiness efforts.
Director, Government & Regulatory Affairs (Hybrid - Washington D.C.,) Broadridge Financial Solutions IncDirector, Government & Regulatory Affairs (Hybrid - Washington D.C.,)Washington, DC$180,000–$190,000 / yearReporting 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.
Senior Director, Regulatory Affairs Strategy - Cell and Gene Therapy AstraZeneca PlcSenior Director, Regulatory Affairs Strategy - Cell and Gene TherapyGaithersburg, MD$218,058–$327,087 / yearAccountabilities: 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.
Sr. Regulatory Affairs Specialist VB Spine LLCSr. Regulatory Affairs SpecialistLeesburg, VA$100,000–$105,000 / yearAs a Senior Regulatory Affairs Specialist in our Regulatory Affairs function within the Spine division, you'll play a key role in planning and executing regulatory strategies to obtain and maintain market approvals for new and existing spinal products across the US, EU, and global markets. At VB Spine, join a high-performing team where you'll play a significant role in bringing innovative spinal technologies to market while ensuring full regulatory compliance - positioning yourself for continued growth in a dynamic, mission-driven medical device company.
Director, Global Regulatory Affairs Lead (Oncology) GSK plcDirector, Global Regulatory Affairs Lead (Oncology)Rockville, MD$171,750–$286,250 / yearProven track record of facilitating groups of individuals to work together on creating solutions and developing regulatory strategies, proactively seeking information and insight from a broad range of sources and weight benefits and risks before making important decisions. Works with the respective GRS TG Portfolio Lead and TG VP to ensure a robust regulatory strategy and appropriate TG resource is in place to support respective development programs to meet the needs of the key markets identified in the IES and the Medicine Profile.
Senior Counsel Regulatory Affairs and Policy PNC BankSenior Counsel Regulatory Affairs and PolicyDistrict of ColumbiaProviding thought leadership and support to PNC’s regulatory strategy and relationships in conjunction with other Legal Department and Regulatory/Government Affairs colleagues; Advising senior management on key regulatory issues and trends and on how to proactively manage regulatory issues and relationships; Providing specialized legal advice and counsel to attorneys supporting the lines of business, as well as management in those areas, on a wide array of regulatory issues in support of the company’s efforts to achieve its business goals in compliance with law and regulation. Ensuring that PNC is in line with industry best practices for a top-tier bank, in its approach to understanding regulatory guidance; Analyzing legislation to identify issues for PNC and drafting legislative amendments to support ongoing advocacy of PNC Government Affairs; Leading the development of comment letters, advocacy materials, and policy positions on significant regulatory and legislative initiatives affecting banking, payments, and digital assets, along with other new regulations and guidelines that impact PNC.
Senior Counsel Regulatory Affairs and Policy The PNC Financial Services Group IncSenior Counsel Regulatory Affairs and PolicyWashington, DC$159,600–$296,400 / yearProviding thought leadership and support to PNC's regulatory strategy and relationships in conjunction with other Legal Department and Regulatory/Government Affairs colleagues; Advising senior management on key regulatory issues and trends and on how to proactively manage regulatory issues and relationships; Providing specialized legal advice and counsel to attorneys supporting the lines of business, as well as management in those areas, on a wide array of regulatory issues in support of the company's efforts to achieve its business goals in compliance with law and regulation. Ensuring that PNC is in line with industry best practices for a top-tier bank, in its approach to understanding regulatory guidance; Analyzing legislation to identify issues for PNC and drafting legislative amendments to support ongoing advocacy of PNC Government Affairs; Leading the development of comment letters, advocacy materials, and policy positions on significant regulatory and legislative initiatives affecting banking, payments, and digital assets, along with other new regulations and guidelines that impact PNC.
Satellite Policy Associate Starlink Regulatory Affairs Space Exploration Technologies CorpSatellite Policy Associate Starlink Regulatory AffairsWashington, DC$160,000–$215,000 / yearOur customers currently include teachers in the most remote parts of the Amazon, researchers in Antarctica, digital nomads who travel via RV, emergency responders, commercial airlines, cruise lines, and residential users who live in more rural or developing areas. ITAR REQUIREMENTS: To conform to U.S. Government export regulations, applicant must be a (i) U.S. citizen or national, (ii) U.S. lawful, permanent resident (aka green card holder), (iii) Refugee under 8 U.S.C. § 1157, or (iv) Asylee under 8 U.S.C. § 1158, or be eligible to obtain the required authorizations from the U.S. Department of State.