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.
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.
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).
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.
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 Manager, Medical/Regulatory Writer Immunocore Holdings PlcSenior Manager, Medical/Regulatory WriterGaithersburg, MDVacancy NameSenior Manager, Medical/Regulatory Writer Vacancy NoVN831 Employment TypeFull Time Location of roleGaithersburg, MD, Radnor, PA, Remote, US DepartmentRegulatory Affairs Key ResponsibilitiesThe Senior Manager, Medical/Regulatory Writer will be accountable for leading and overseeing the medical and scientific regulatory writing for assigned programs to support submissions from first-in-human studies through product registration. Authoring or supervising the preparation of other regulatory documents required for Health Authority submissions, including but not limited to: Clinical Summaries (Clinical Overview, ISS/ISE, PK/PD summary, Advisory Committee Briefing document), Investigator Brochure(s), DSURs, other regulatory documents including briefing documents for health authorities, responses to Health Authority questions, etc.
Senior CMC Regulatory Strategy Manager GSK plcSenior CMC Regulatory Strategy ManagerRockville, MD$144,375–$240,625 / 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. Directs and communicates complex regulatory issues independently across the company and with external agencies and third parties as necessary, to influence project and policy issues that are aligned with business needs ensuring optimum position for the company.
Sr Manager, Regulatory Advisory Compliance T. Rowe PriceSr Manager, Regulatory Advisory ComplianceOwings Mills, MarylandSuccess in this role requires deep expertise in compliance and registration disciplines, exceptional communication skills, demonstrated experience with handling multiple tasks at the same time, strong attention to detail, self-motivation, and the ability to influence management and key external stakeholders on broad-ranging initiatives. As a premier global asset management organization with more than 85 years of experience, we provide investment solutions and a broad range of equity, fixed income, and multi-asset capabilities to individuals, advisors, institutions, and retirement plan sponsors.
Regulatory Risk & Quality Manager CiconixRegulatory Risk & Quality ManagerFort Detrick, MarylandProvide subject matter expertise and support for the development and implementation of in-house quality systems and procedures, to include the development/writing of new SOPs to support ORA compliance Survey personnel, review procedures, assess facilities, and write SOPs for entities conducting or assisting with non-clinical studies, clinical studies, or manufacturing test articles (Deliverable 60). Prepare clinical quality assurance management plans IAW Federal Code, guidance documents, including 21 CFR Part 312, 21 CFR Part 812, ICH Good Clinical Practice E6, and ISO 14155, and either Government SOPs or Contractor SOPs that have been reviewed and approved by the Government.
Procurement Regulatory Compliance Manager Johns Hopkins Applied Physics LaboratoryProcurement Regulatory Compliance ManagerLaurel, MarylandFull timeAs part of the Procurement Compliance Section support both internally and externally conducted audits including reviewing procurement purchase order and subcontract documentation, responding to auditor questions, and addressing any post-audit actions. As a Procurement Compliance Manager your primary responsibility will be to proactively assess the impact of changing regulations in the Federal Acquisition Regulation and Defense Federal Acquisition Regulation relating to Procurement, new Executive Orders, and other related government audit trends.
Food Safety Program Manager - Regulatory Support Chewy IncFood Safety Program Manager - Regulatory SupportJessup, MDWhat You'll Need: BS in Chemistry, Biology, Food Safety, Food Science, Environmental; Engineering; or related technical field is; required; Advanced MS in Chemistry, Biology, Food Safety, Food Science, Environmental; Engineering; or related technical field is preferred; Minimum of 2+ years in Food Safety and Quality Control in a distribution, warehousing, and/or manufacturing setting. The Regional Food Safety Specialist will; be responsible for; partnering with the Site Operations team, Continuous Improvement, Learning, Quality, and Facility teams to manage the deliverables; required; at the FC network.
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.
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.
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.
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 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.
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.
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.
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.
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.
Washington and Regulatory Research Associate Analyst T. Rowe Price Group IncWashington and Regulatory Research Associate AnalystBaltimore, MD$110,000–$160,000 / yearConducting analysis of regulatory, legal, and policy decisions made across the US government, both at a federal (congressional, executive, agency, judicial) and local (state legislature, judicial) level, with the goal of forecasting likely outcomes and their implications for markets and particular companies. As a premier global asset management organization with more than 85 years of experience, we provide investment solutions and a broad range of equity, fixed income, and multi-asset capabilities to individuals, advisors, institutions, and retirement plan sponsors.
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.
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.
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.
Manager, Alumni Social Media Covista IncManager, Alumni Social MediaColumbia, MD$70,000–$85,000 / yearThis role is responsible for developing and executing social media strategies that elevate alumni voices, strengthen engagement and enhance our institutional brand reputations including American University of the Caribbean School of Medicine, Chamberlain University, Ross University School of Medicine, Ross University School of Veterinary Medicine and Walden University. This role partners closely with internal stakeholders, alumni communications leadership, ambassador program leaders, and marketing teams to ensure consistent, high-quality, on-brand storytelling for each institution"s alumni community.
Senior Manager, Drug Safety and Medical Monitor Supernus Pharmaceuticals IncSenior Manager, Drug Safety and Medical MonitorRockville, MD$131,000–$155,000 / yearConduct medical reviews of Individual Case Safety Reports (ICSRs), including Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Adverse Drug Reactions (ADRs), causality assessments, signal detection, case narratives, aggregate reports, and safety data listings, and communicate all applicable comments to the Pharmacovigilance Lead. Conduct medical reviews of clinical trial documents including clinical trial protocols, informed consent forms, Investigator's Brochure and other essential study documents and plans, and provide input to Clinical Development, Medical Writing, and Clinical Operations teams.
Senior Manager, Drug Safety and Medical Monitor Supernus PharmaceuticalsSenior Manager, Drug Safety and Medical MonitorRockville, MarylandConduct medical reviews of Individual Case Safety Reports (ICSRs), including Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Adverse Drug Reactions (ADRs), causality assessments, signal detection, case narratives, aggregate reports, and safety data listings, and communicate all applicable comments to the Pharmacovigilance Lead. Conduct medical reviews of clinical trial documents including clinical trial protocols, informed consent forms, Investigator’s Brochure and other essential study documents and plans, and provide input to Clinical Development, Medical Writing, and Clinical Operations teams.
Site Manager CHES Chesapeake Urology AssociatesSite ManagerColumbia, MarylandWe deliver a cohesive approach to urologic care that provides patients with access to experienced specialists, a superb team of healthcare professionals, and the most advanced technology for patient treatments and therapies. Develop and implement clinic-specific strategic plans aligned with the organization's goals through close interaction with the Regional Director of Operation, Chief Operating Officer, and Physicians.
Senior Manager, Trade Compliance and Logistics *PC 809 Miltenyi Biotec GmbHSenior Manager, Trade Compliance and Logistics *PC 809Gaithersburg, MDDrive Coordination of efforts to meet and maintain high-performance levels for import/export requirements, in which entails; to monitor & audit daily import and export entry transactions are in compliance with Customs, including, but not limited to resolve discrepancies, requesting corrective action with customs administrative entry submission as appropriate with support of 3PL, brokers, etc. Requirements: Bachelor's degree in international business, supply chain management, logistics, law, or a related field; Experience:?5+ years of experience in leadership with related fields in international trade compliance or global logistics, law, supply chain management.
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.
Senior Manager, Trade Compliance and Logistics *PC 809 Miltenyi BiotecSenior Manager, Trade Compliance and Logistics *PC 809Gaithersburg, MarylandDrive Coordination of efforts to meet and maintain high-performance levels for import/export requirements, in which entails; to monitor & audit daily import and export entry transactions are in compliance with Customs, including, but not limited to resolve discrepancies, requesting corrective action with customs administrative entry submission as appropriate with support of 3PL, brokers, etc. Miltenyi Bioindustry plays a unique role as both the producer and the service provider, relying on our instruments and reagents for each workflow step, controlling the entire supply chain and thus delivering greater security and planning clarity to our customers.
Project Manager - Healthmark QMS, Defined Term (Remote in EST) Getinge ABProject Manager - Healthmark QMS, Defined Term (Remote in EST)Baltimore, MDRemote$120,160–$150,000 / yearRequired Knowledge, Skills and Abilities: Expert-level working knowledge of FDA 21 CFR Part 820 / Quality Management System Regulation (QMSR), including its incorporation of ISO 13485:2016 effective February 2026. The project manager will serve as the primary driver of project(s) execution across a group of QMS workstreams, coordinating cross-functional teams and ensuring delivery against defined milestones.
Clinical Research Data and Analytics Manager (Hybrid) The Geneva FoundationClinical Research Data and Analytics Manager (Hybrid)Bethesda, MarylandReporting to the Senior Manager of Regulatory Affairs & Data, this role directly oversees a small, dedicated team (including a Clinical Data Manager and a Data Management Analyst) supporting a robust portfolio of 65+ active multi-site research studies, including federally funded, FDA-regulated and industry-sponsored clinical trials, across military treatment facilities, academic institutions, and other sites nationwide. Headquartered at the Uniformed Services University of the Health Sciences (USU) in Bethesda, MD, MIRROR provides coordination and support of inter-service and inter-disciplinary partnerships across military treatment facilities (MTFs), military training centers (MTCs), and civilian academic centers to execute cutting-edge research in order to mitigate the burden of MSI on military readiness.
NewManager, QA & Compliance Alertus Technologies, LLCManager, QA & ComplianceBaltimore, MD$85,000–$133,500 / yearOur Product Development team is seeking a Manager, QA & Compliance to lead our efforts in maintaining product certifications and regulatory compliance, while also taking charge of pinpointing and resolving potential quality concerns in our deployed products. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information.