Associate Director Government Affairs LundbeckAssociate Director Government AffairsWashington, DC$200,000–$220,000 / yearThe role represents Lundbeck with federal policymakers, trade associations, patient and provider organizations, and other external stakeholders while providing strategic policy insights, identifying emerging legislative and regulatory issues, and collaborating across the enterprise to support informed business decisions and effective advocacy. Develops and executes federal advocacy initiatives by building and maintaining strategic relationships with Members of Congress, Congressional staff, federal agencies, and other key policymakers, with particular focus on priority committees, leadership offices, and targeted state delegations.
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.
Remote Senior Policy Analyst VETS, IncRemote Senior Policy AnalystFalls Church, VARemoteHowever, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. VETS Inc. is seeking experienced professionals to support a U.S. Army Medical Command (MEDCOM) Disability Evaluation System (DES) support opportunity.
NewSenior Associate, Digital Trust & Safety KPMGSenior Associate, Digital Trust & SafetyWashington, DCIf you're looking for a firm with a strong team connection where you can be your whole self, have an impact, advance your skills, deepen your experiences, and have the flexibility and access to constantly find new areas of inspiration and expand your capabilities, then consider a career in Advisory. These include the duties and responsibilities listed above, as well as the abilities to adhere to company policies, exercise sound judgment, effectively manage stress and work safely and respectfully with others, exhibit trustworthiness, and safeguard business operations and company reputation.
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.
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.
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.
Regulatory Affairs Director, Digital Projects AstraZeneca PlcRegulatory Affairs Director, Digital ProjectsGaithersburg, MD$186,232.80–$279,349.20 / yearThe Regulatory Affairs team leads the development and execution of regulatory strategies for global programs across the entire lifecycle, proactively leveraging and applying broad regulatory and scientific expertise, leadership skills, and business acumen to identify and champion innovative drug development strategies to benefit patients. RADs are accountable for leading the development and implementation of the global regulatory strategy for a product, ensuring the strategy is designed to deliver rapid approval with competitive labelling in line with product considerations, and the needs of the business, markets, and patients.
Head of Government and Regulatory Affairs Resolution Life Group Holdings LtdHead of Government and Regulatory AffairsWashington, DC$285,000–$440,000 / yearThe Head of Government and Regulatory Affairs will be accountable for establishing and operating a coordinated government and regulatory affairs function, including identifying and assessing legislative, regulatory, supervisory, and public policy developments that may affect Resolution Life, developing and implementing results-drive advocacy strategies to advance key business priorities, coordinating regulatory and government engagement, and representing the company with regulators, government officials, industry forums, and trade associations. The role will report to the Head of Legal & Compliance and will also work closely with the Chief Executive Officer, North America, Chief Risk Officer, Chief Legal, People & Partnerships Officer, and other senior leaders across the global business.
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.
Senior Director, Regulatory Affairs (Ad Promo) Bausch Health Companies IncSenior Director, Regulatory Affairs (Ad Promo)Washington, DC$215,000–$296,000 / yearRepresents regulatory affairs in cross functional prescription product promotional review teams as required, participate in development committees for processes and procedures relating to ad promo. Job Location: Washington, District of Columbia, USA | Boston, Massachusetts, USA | Bridgewater, New Jersey, USA | NewYorkCity, New York, USA | Philadelphia, Pennsylvania, USA.
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.
Senior Small Molecule Regulatory Affairs & Compliance Subject Matter Expert Tunnell Government ServicesSenior Small Molecule Regulatory Affairs & Compliance Subject Matter ExpertWashington, DCRemoteThe Senior Small Molecule Regulatory Affairs & Compliance SME will provide strategic regulatory expertise, program management support, and technical guidance for the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR®) initiative and related pharmaceutical manufacturing programs. The candidate will work closely with Government leadership, pharmaceutical manufacturers, CDMOs, regulatory agencies, quality organizations, and technical teams to ensure products and manufacturing operations meet regulatory requirements and support program objectives.
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.
Senior Regulatory Affairs Specialist PhilipsSenior Regulatory Affairs SpecialistWashington, DC$99,000–$157,000 / yearThe 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.
Director Promotional Regulatory Affairs AstraZeneca PlcDirector Promotional Regulatory AffairsGaithersburg, MDAccountabilities: Regulatory Promotion Review: Drive efficient and effective regulatory review and risk assessment for promotional materials across HCP, Consumer, and Managed Markets segments and all media types, including sales and faculty training, scientific exchange, and Corporate Affairs communications, through established systems. Training and Capability Building: Evaluate brand regulatory training needs and develop and deliver training in partnership with internal/external Learning teams or the PRA Skill Center, building regulatory acumen across the business.
Senior Regulatory Affairs Specialist (Columbia, MD) Smith & Nephew PlcSenior Regulatory Affairs Specialist (Columbia, MD)Columbia, MD$101,500–$152,250 / yearThe 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. Act as NPD regulatory lead on new device-biologics combination products and define regulatory strategy for FDA submissions including authoring FDA 510(k) submissions and FDA pre-submissions.
Regulatory Affairs Director AstraZeneca PlcRegulatory Affairs DirectorGaithersburg, MD$178,534–$267,801 / yearCompetitive 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).
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.