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.
NewSenior 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.
Regulatory Affairs Specialist (Innovation) Becton Dickinson and CoRegulatory Affairs Specialist (Innovation)MD$95,900–$153,400 / yearWaters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. The Regulatory Affairs Specialist (Innovation) is responsible for providing regulatory guidance, developing regulatory strategies, and conducting risk assessments, to new product development (NPD) teams for in vitro diagnostic (IVD) products.
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.
Director, Regulatory Affairs Liaison, Vaccines & Infectious Diseases Merck & Co IncDirector, Regulatory Affairs Liaison, Vaccines & Infectious DiseasesRockville, MD$210,400–$331,100 / yearRequired Skills: Biological Sciences, Biostatistics, Clinical Judgment, Clinical Trial Planning, Clinical Trials, Communication, Cross-Functional Collaboration, Detail-Oriented, Infectious Disease, Leadership, Medical Writing, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Intelligence, Regulatory Issues, Regulatory Strategy Development, Regulatory Writing. Primary activities include, but are not limited to: Functions with a high degree of independence and provides regulatory oversight for assigned products, functioning as the single, accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.
Sustaining & Compliance Projects Senior Manager, Regulatory Affairs Becton Dickinson and CoSustaining & Compliance Projects Senior Manager, Regulatory AffairsMD$149,600–$239,400 / yearWaters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Develops direct reports with regard to required competencies, including, but not limited to, regulatory knowledge and ability to apply this knowledge, effectiveness in team and one-to-one interactions, and verbal and written communications.
Associate Director/Senior Manager Regulatory Affairs Precigen IncAssociate Director/Senior Manager Regulatory AffairsGermantown, MDParticipation 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.
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.
Scientific Program Manager (Regulatory Affairs) (51824) Gap Solutions, Inc.Scientific Program Manager (Regulatory Affairs) (51824)Bethesda, MDThese documents include, but are not limited to, clinical study protocols, informed consent documents, to ensure test plans encompass all required test elements, data parameters, test objectives, chemistry manufacturing and control (CMC) documents, and nonclinical study report summaries. Manage complex systems for data management and document control; supporting the dissemination of information on vaccine, monoclonal antibody, and other VRC clinical trials and collaborations using VRC products; and responds to related inquiries by sites, sponsors, FDA, and international regulatory agencies.
Director Promotional Regulatory Affairs AstraZeneca PlcDirector Promotional Regulatory AffairsGaithersburg, MDDesirable 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.
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).
Regulatory Affairs Strategy Director AstraZeneca PlcRegulatory Affairs Strategy DirectorGaithersburg, MD$186,232.80–$279,349.20 / 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. 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.
Vice President, Global Head of Regulatory Affairs Qiagen NVVice President, Global Head of Regulatory AffairsGermantown, MDCreate 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.
NewExecutive Director, Regulatory Affairs Strategy - Cell Therapy AstraZeneca PlcExecutive Director, Regulatory Affairs Strategy - Cell TherapyGaithersburg, MD$276,000–$414,000 / yearMilestone 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. GRST Leadership and Talent Development: Lead one or more Global Regulatory Strategy Teams focused on indications, programs, or franchise priorities; provide leadership, coaching, and performance feedback; line-manage 3-7 regulatory team members; contribute to succession planning, capability building, and development of senior regulatory talent.
Manager, Regulatory Affairs - Advertising and Promotion Supernus Pharmaceuticals IncManager, Regulatory Affairs - Advertising and PromotionRockville, MD$100,000–$140,000 / yearSupernus 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.
Strategy Lead, CMC Mature, Regulatory Affairs GSK plcStrategy Lead, CMC Mature, Regulatory AffairsRockville, MD$113,850–$189,750 / yearGSK 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.
Senior Regulatory Affairs Director - Oncology AstraZeneca PlcSenior Regulatory Affairs Director - OncologyGaithersburg, MD$211,581.60–$317,372.40 / 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. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Regulatory Affairs Manager Katalyst Healthcares & Life SciencesRegulatory Affairs ManagerBaltimore, MDProvide 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).
Director of Regulatory Affairs,Tactical and Implementation Immunocore Holdings PlcDirector of Regulatory Affairs,Tactical and ImplementationGaithersburg, MD$157,500–$262,500 / yearExperience & 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.
Consultant, Regulatory Affairs John Staurulakis (jsitel.com)Consultant, Regulatory AffairsGreenbelt, MarylandClient Leadership & Account Management: Serve as the primary client representative and account manager for a large, diverse portfolio of accounts — including CLECs, MVNOs, nationwide telecom providers, and aggregators — ensuring exceptional service delivery and long-term client retention. JSI invites you to join our team as a Consultant, Regulatory Affairs on our Regulatory team in our Maitland, FL , Greenbelt, MD , or Remote locations where you'll play a critical role in advancing broadband and telecommunications initiatives that expand connectivity and drive digital inclusion—while advancing your career within a mission-driven, growth-focused organization.
Director, Regulatory Affairs, Competitive Markets John Staurulakis (jsitel.com)Director, Regulatory Affairs, Competitive MarketsGreenbelt, MarylandPosition Overview: As a Director, Regulatory Affairs, Competitive Markets , you will serve as the face of our firm to a significant portfolio of client accounts spanning CLECs, MVNOs, nationwide telecommunications providers, and aggregators — acting simultaneously as trusted advisor, dedicated account manager, expert regulatory consultant and business development driver. Team Leadership & Supervision: Provide active leadership, direct supervision, and day-to-day guidance to junior consultants and support staff assigned to client accounts — setting priorities, removing barriers, ensuring accountability, and helping the team deliver accurate, timely, high-quality work.
Manager, Regulatory Affairs - Advertising and Promotion Supernus PharmaceuticalsManager, Regulatory Affairs - Advertising and PromotionRockville, MarylandSupernus 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.
Regulatory Affairs Specialist, EHS, North America Henry Schein IncRegulatory Affairs Specialist, EHS, North AmericaMD$56,604–$88,443 / yearDevelop and deliver employee environmental, health, and safety (EHS) awareness and training programs to ensure compliance with applicable federal, state, and international regulations, including OSHA, OSHA State Plans (e.g., Cal/OSHA), DOT, IATA, IMO, and EPA requirements. Proficient in Microsoft Office applications, including PowerPoint, and experienced with project management methodologies and tools commonly used in the medical device or pharmaceutical industries.
Executive Director, Regulatory Affairs Precigen IncExecutive Director, Regulatory AffairsGermantown, MDThis 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.
Director Global Regulatory Affairs LancesoftDirector Global Regulatory AffairsBaltimore, MDRemote$302This role serves as a strategic integrator within the US team of the Global Regulatory Policy and Innovation (GRPI) team, translating emerging external policy, regulatory, and scientific developments into actionable insights that shape R&D and portfolio decisions. The position is designed to move beyond monitoring activity to influencing how the organization anticipates and navigates change, partnering closely across R&D, Regulatory, and Public Affairs to drive aligned and informed decision-making.
CMC Director, Regulatory Affairs AltimmuneCMC Director, Regulatory AffairsGaithersburg, MDFull timeJob Description : This individual will be responsible for providing global regulatory CMC support throughout the product lifecycle (e.g., regulatory strategies, preparing CMC filings and submissions to regulatory applications, regulatory submission timeline development, and regulatory intelligence). Responsible for the preparation of all CMC sections/information filed in support of global clinical trial and marketing applications; ensures all CMC regulatory filings are prepared accurately and completed in a timely manner.
Senior Regulatory Affairs Scientist CiconixSenior Regulatory Affairs ScientistFort Detrick, MarylandThe target product profiles shall contain the indication and usage, dosage and administration, dose forms and strengths, contraindications, warning and precautions, safety adverse reactions and drug interactions, use in specific populations, drug abuse and dependence/overdose, description of drug, clinical/pharmaceutical, pre-clinical toxicology, clinical studies, references, storage and handling, patient counseling, risk evaluation mitigation strategy, and supporting documentation and/or templates as appropriate. About the Role: Ensure compliance with FDA Sponsor responsibilities, serve as a subject matter expert for regulatory strategy including identifying and mitigating risk, and providing support to integrated project teams and working groups for submissions to and communications with the Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health submissions.
R0000030967 Senior / Vice President, Technical - Clinical Regulatory Affairs (home-based) Parexel International CorpR0000030967 Senior / Vice President, Technical - Clinical Regulatory Affairs (home-based)MDWe're currently seeking a highly experienced Clinical Regulatory Leader, Health Authority Medical Review Team Lead, Master/Senior Medical Review Officer who is looking to draw upon their wealth of experience in clinical trial design and drug development to join Parexel's highly recognized Regulatory Strategy team! Minimum Work Experience - 15+ years experience with expert level industry or regulatory knowledge experience in Clinical Development/Clinical Trial Design, Clinical Strategy, and authoring clinical sections of regulatory applications.
Senior / Vice President, Technical - Clinical Regulatory Affairs (home-based) ParexelSenior / Vice President, Technical - Clinical Regulatory Affairs (home-based)MarylandWe’re currently seeking a highly experienced Clinical Regulatory Leader, Health Authority Medical Review Team Lead, Master/Senior Medical Review Officer who is looking to draw upon their wealth of experience in clinical trial design and drug development to join Parexel’s highly recognized Regulatory Strategy team! Minimum Work Experience - 15+ years experience with expert level industry or regulatory knowledge experience in Clinical Development/Clinical Trial Design, Clinical Strategy, and authoring clinical sections of regulatory applications.
Sr Extern Affairs Specialist - BGE Permitting ExelonSr Extern Affairs Specialist - BGE PermittingBALTIMORE, MDWe are a Fortune 200 company, 20,000 colleagues strong serving more than 10.7 million customers at six energy companies -- Atlantic City Electric (ACE), Baltimore Gas and Electric (BGE), Commonwealth Edison (ComEd), Delmarva Power & Light (DPL), PECO Energy Company (PECO), and Potomac Electric Power Company (Pepco). + Bachelor’s degree in political science, communications, business administration, and/or public relations AND 4-7 years related experience in governmental affairs, customer service, communications, or relevant utility experience OR, in lieu of a bachelor’s degree, 6-9 years relevant experience is required.
Vice President of Public Policy & Federal Affairs (Hybrid) Blue Cross and Blue Shield AssociationVice President of Public Policy & Federal Affairs (Hybrid)Baltimore, MD$235,520–$353,280 / yearexecutives; monitoring and analyzing healthcare policy issues at the federal and state levels and creating and supporting public affairs campaigns in support of CareFirst''s local, federal, and state policy positions in partnership with CareFirst''s Public Relations and State Government Affairs teams, and other enterprise-wide executives to advance legislative, regulatory, and other advocacy campaigns. ESSENTIAL FUNCTIONS: Federal Relationships and Advocacy: Oversee engagement of federal government officials and their staffs on behalf of CareFirst to ensure that the Companys position is considered in legislative and regulatory decisions and that legislation and regulations introduced or amended are consistent with CareFirst policy and objectives.
Specialist, Medical Affairs Becton Dickinson and CoSpecialist, Medical AffairsSparks, MD$75,800–$121,300 / yearWaters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. This role provides insight on intended use, laboratory workflows, and patient impact/clinical unmet needs to help ensure alignment with real-world clinical practice while partnering with other Medical Affairs functions, as well as R&D, Quality, Regulatory, and Commercial teams.
Director of Contracts and Legal Affairs EMCOR Group IncDirector of Contracts and Legal AffairsBaltimore, MDThis role reports to the President & CEO and works closely with executive leadership, operations, estimating, procurement, and risk management to mitigate risk, support project delivery, and ensure contractual compliance across all phases of the project lifecycle. Our construction and service (mechanical and electrical) experience includes a broad range of commercial and government projects, including data centers, hospitals, sports stadiums, convention centers, hotels, and research laboratories.
Global Medical Affairs Leader COPD Omnichannel Confidence and Advocacy AstraZeneca PlcGlobal Medical Affairs Leader COPD Omnichannel Confidence and AdvocacyGaithersburg, MD$193,281–$289,922 / yearGuideline and GDMT Support: Collaborate with country medical teams to support the adoption and execution of guideline-driven initiatives and accelerate GDMT (Guideline-Directed Medical Therapy) implementation; supply scientifically validated resources and frameworks to ensure consistency with local healthcare practices. Essential for the Role: Demonstrate in-market or regional medical affairs expertise in Respiratory, translating scientific evidence and market dynamics into actionable medical strategies and advocacy roadmaps tailored to local needs; successfully led advocacy initiatives in a local context.
Director of Contracts and Legal Affairs The Poole and Kent CorporationDirector of Contracts and Legal AffairsBaltimore, MarylandFull timeThis role reports to the President & CEO and works closely with executive leadership, operations, estimating, procurement, and risk management to mitigate risk, support project delivery, and ensure contractual compliance across all phases of the project lifecycle . Our construction and service (mechanical and electrical) experience includes a broad range of commercial and government projects, including data centers, hospitals, sports stadiums, convention centers, hotels, and research laboratories.
Senior Public Affairs Opinion Writer (PART TIME) USPSenior Public Affairs Opinion Writer (PART TIME)Rockville, MarylandThe ideal candidate is a strong writer first — someone who can work under ambiguity, manage multiple stakeholders, and shift between issues and points of view — while also working with executives and learn to communicate in their voice while serving as a thought partner to communications managers in shaping and executing messaging strategy. Instead, the focus is on editorial, issues driven content that conveys USP’s point of view to policymakers, regulators, industry leaders, trade associations, patient organizations and others to expand stakeholder perspectives and enlist them in USP’s work.
Sr Director - North America Government Affairs Motorola Solutions IncSr Director - North America Government AffairsMD$190,000–$200,000 / yearInternal Collaboration: Collaborate closely with internal stakeholders, including business unit leaders, legal, communications, marketing, and technical teams to ensure alignment on policy positions and effective execution of government affairs initiatives. Global Relationship Management and Advocacy: Align with the international teams to engage with foreign governments, international organizations, and other relevant stakeholders to promote favorable policy outcomes and address regulatory challenges in key markets around the world.
Senior Public Affairs Specialist BarbaricumSenior Public Affairs SpecialistFort Detrick, MDBarbaricum is currently seeking a proficient Public Affairs Specialist to join our dynamic team in support of the Program Executive Office Soldier, focusing on the engineering, building, testing, and deployment of innovative cloud service offerings. Writes articles and speeches for organizational official(s) to specialized publics; prepares and publishes organization publications in keeping al internal personnel informed of programs, activities, and career information.
Assistant Provost for Faculty Affairs and Labor Relations Frostburg State UniversityAssistant Provost for Faculty Affairs and Labor RelationsMD$125,000–$140,000 / yearThe Assistant Provost for Faculty Affairs and Labor Relations serves as a senior leadership position within the Office of the Provost and plays a central role in advancing the institution's academic mission through effective faculty administration, equitable personnel practices, and constructive labor-management relations. About the University: A member institution of the University System of Maryland, Frostburg State University is a public, comprehensive, largely residential regional university offering programs in the sciences, education, business, the arts and humanities at both the undergraduate and graduate levels.
Scientific Affairs Manager ( Biologics) USPScientific Affairs Manager ( Biologics)Rockville, MarylandThe Scientific Affairs Manager plays a critical role in communicating and amplifying USP’s science across the region, strengthening scientific visibility and external engagement with customers, regulatory authorities, and key stakeholders. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1,300 professionals across twenty global locations, working to strengthen the supply of safe, high-quality medicines worldwide.
Sr. Principal Scientist (Sr. Director) - Regulatory Liaison Merck & Co IncSr. Principal Scientist (Sr. Director) - Regulatory LiaisonRockville, MD$190,800–$300,300 / yearRequired Skills: Biological Sciences, Clinical Reporting, Drug Development, Global Health, In Vitro Diagnostics (IVD), Multiple Therapeutic Areas, Pharmaceutical Regulatory Affairs, Process Improvements, Product Approvals, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Issues, Regulatory Strategies, 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.
Director, Communications, R&I Global Corporate Affairs AstraZeneca PlcDirector, Communications, R&I Global Corporate AffairsGaithersburg, MD$146,716.80–$220,075.20 / yearDevelop and deliver global communications plans from Phase 2b through launch with consideration of the full franchise, including milestones, data readouts, regulatory events, congress presence, partnerships and competitive responses. Credible advisor to senior leaders; adept at translating strategy into communications (including PowerPoint and digital); strong cross-functional and cross-geography influence.
Director of Government & Legislative Affairs (DESIGNATED ADMIN MANAGER III) State of MarylandDirector of Government & Legislative Affairs (DESIGNATED ADMIN MANAGER III)Annapolis, MDThe Director will oversee DGSâs Office of Government & Legislative Affairs and will provide updates to the Office of the Assistant Secretary of External Affairs, the Secretary of DGS, and other appropriate executive staff as it relates to legislative activities both during and outside of the annual Legislative Session of the Maryland General Assembly (MGA). The Maryland Department of General Services (DGS) supports State and local government agencies, as well as local non-profit organizations and the citizens of Maryland, by providing facilities management, real estate and surplus property services, as well as security and law enforcement for State buildings.
Leader Medical Affairs Canon USA & AffiliatesLeader Medical AffairsAnnapolis, MDRemote10 years’ experience as a Medical Physicist, Scientist, or MD in a clinical hospital or clinical research setting or 3 years of experience as a Medical Physicist, Scientist, or MD in a clinical hospital or clinical research setting plus 7 years of experience in healthcare industry as imaging scientist or research manager. Analyze and communicate technical and clinical product specification requirements from luminaries, market research teams, and via Medical Advisory Boards (MABs) to global business team.
Regional Lead - Government & Industry Affairs VGW Holdings LtdRegional Lead - Government & Industry AffairsMDRemote$160,000–$210,000 / yearReporting into the VP of Government Relations, this role translates VGW's lobbying strategy into targeted, state-specific lobbying campaigns managing a roster of external contract lobbyists, developing relationships with state government officials, and delivering actionable field intelligence back to central leadership. Key responsibilities will include: Serve as the primary accountability manager for all external lobbyists within the assigned regional portfolio: set performance expectations, respond to their queries in a timely manner, review deliverables, conduct weekly check-ins, and provide written performance assessments.
Regulatory Scientific Reviewer (Regulatory Specialist) US Department of Health and Human ServicesRegulatory Scientific Reviewer (Regulatory Specialist)Rockville, MD$102,415–$138,182 / yearThe Food and Drug Administration is the regulatory, scientific, public health, and consumer protection agency responsible for ensuring that all human and animal drugs, and medical devices are safe and effective, that cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, and radiation emitting devices are safe, and that all such products marketed in the United States are adequately, truthfully and informatively labeled and safely and properly stored, transported, manufactured packaged and regulated. Basic Qualification Requirements: A bachelors or graduate/higher level degree in quality assurance or a related degree in one or a combination of the following: consumer laws, biological sciences, food science, chemistry, pharmacy, physical sciences, food technology, nutrition, medical science, engineering, epidemiology, veterinary medical science, legal investigations, law enforcement, or related scientific fields that provided knowledge directly related to consumer product reviewer work.
NewSr. Medical Writer (Regulatory) Syneos HealthSr. Medical Writer (Regulatory)MarylandInteracts and builds good working relations with clients, department head, and peers in data management, biostatistics, regulatory affairs, and medical affairs, as necessary, to produce writing deliverables. • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
Executive Director, Enterprise Regulatory Policy Strategy Merck & Co IncExecutive Director, Enterprise Regulatory Policy StrategyRockville, MD$231,900–$365,000 / yearDoctorate degree and at least 5 years' experience with FDA or other health authority, either directly (working within a health authority) or indirectly (closely interacting with health authority) OR Master's degree and at least 8 years' experience with FDA or other health authority, either directly (working within a health authority) or indirectly (closely interacting with health authority) OR Bachelor's degree and at least 10 years' experience with FDA or other health authority, either directly (working within a health authority) or indirectly (closely interacting with health authority), with demonstrated senior level experience engaging health authorities. The Executive Director (ED) will be a strong subject matter expert in regulatory processes, policies, laws, and regulations, with a deep understanding of how regulatory policy is shaped and influenced, and the credibility, relationships, and strategic judgment required to drive alignment and advance regulatory policy priorities in direct support of our Research and Development (R&D) goals, including enabling timely filings and accelerating pipeline progression through consistent, high impact external policy engagement.
Senior Analyst, Regulatory John Staurulakis (jsitel.com)Senior Analyst, RegulatoryGreenbelt, MarylandJSI invites you to join our team as a Senior Analyst on our Regulatory team in our Greenbelt, MD or Austin, TX office where you'll play a critical role in advancing broadband and telecommunications initiatives that expand connectivity and drive digital inclusion—while advancing your career within a mission-driven, growth-focused organization. With clients nationwide and a powerful presence in markets across the United States, JSI empowers rural and regional broadband providers to expand, evolve, and excel in a rapidly shifting digital world.