Director, Medical Insights Pfizer IncDirector, Medical InsightsCambridge, MA$176,600–$294,300 / yearA core focus of the role is to maximize the value and impact of Medical Insights by embedding them effectively into medical processes, strategic discussions, and decision‑making, leveraging advanced analytics, artificial intelligence, and emerging technologies to translate complex medical data into actionable insights that support scalable, value‑driven, and data‑informed decisions across Pfizer's portfolio of medicines. Bachelor's degree or higher in Life Sciences, Biomedical Sciences, Pharmaceutical Sciences, Data Sciences, Data Analytics, or a related field, with 8+ years of relevant experience in the pharmaceutical or life sciences industry; 7+ with Masters; 5+ with PharmD/PHD.
Project Manager Tailored ManagementProject Managercambridge, MA$100–$130 / hourOwn the integrated development and operating plan, including timelines, critical path, milestones, deliverables, and resource and budget assumptions, ensuring all cross-functional workstreams are fully integrated into the overall asset plan. Lead coordination across core functions including Clinical Development, Regulatory Affairs, Medical and Patient Engagement, Market Access and Commercial, and CMC/Supply to ensure clear accountability, alignment, and delivery against key milestones.
Director, US Regulatory Affairs - Advertising And Promotion (Hybrid) SanofiDirector, US Regulatory Affairs - Advertising And Promotion (Hybrid)Cambridge, MA$178,500–$257,833.33 / yearDirector/Product Support Head, imparts senior regulatory guidance and advice during issues management activities; provides oversight and guidance for Rapid Response Teams, and functions as the therapeutic product expert. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen.
NewDirector, Global Regulatory Affairs Stoke Therapeutics, Inc.Director, Global Regulatory AffairsBedford, MA$248,000–$280,000 / yearPosition Purpose: The Director, Global Regulatory Strategy will be responsible for developing and delivering global regulatory strategies to ensure products are developed, approved, and maintained in compliance with health authority requirements and in alignment with the corporate strategy for Stoke's portfolio. Develops and maintains current regulatory knowledge and provides guidance to regulatory staff and company management; identifies the need for new or expanded regulatory policies, processes and SOPs, and approves and ensures implementation to establish a compliant culture.
Senior Manager, Regulatory Affairs Kymera TherapeuticsSenior Manager, Regulatory AffairsWatertown, MA$145,000–$215,000 / yearHaving advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Reporting to the Director of Regulatory Affairs, the Senior Manager will independently lead regulatory activities at the study level, acting as the regulatory representative on cross-functional teams while driving execution of program regulatory strategies.
NewRegulatory Affairs Manager AstraZeneca PlcRegulatory Affairs ManagerCambridge, MA$109,244.80–$163,867.20 / yearSupport operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, submission tracking, TMF, and document management utilizing the support and input of GRO, MCs, CROs and/or alliance partners where relevant. The RAM provides regulatory expertise and guidance on procedural and documentation requirements to GRET, GRST and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.
Sr. Regulatory Affairs Spclst DeephealthSr. Regulatory Affairs SpclstSomerville, Massachusetts$120,000–$165,000 / yearFull timeRegulatory Affairs Specialist, this position will: · Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for non-medical devices, and medical devices. · Create and ensure maintenance of technical documentation (such as clinical evaluation reports, risk management reports, 510(k) notification) as required for obtaining and/or maintaining regulatory approval/clearance for DeepHealth products.
Project Manager Integrated Resources, IncProject ManagerCambridge, MA$100–$125 / hourLead coordination across core functions including Clinical Development, Regulatory Affairs, Medical and Patient Engagement, Market Access and Commercial, and Client/Supply to ensure clear accountability, alignment, and delivery aProductst key milestones. Lead program governance in close partnership with the PDC Lead, including preparation and orchestration of PDC and sub-team forums, structuring decision frameworks, and ensuring clarity on decision versus information topics.
Senior Faculty Affairs Partner University of Massachusetts AmherstSenior Faculty Affairs PartnerAmherst, MAAt any one time, the College maintains approximately 240 employee appointments, including tenure system faculty, part-time and full-time lecturers, permanent and temporary staff members, post-doctoral research associates, graduate teaching assistants, and student employees. In collaboration with the Provost's Office, the Office of Human Resources, and campus stakeholders, the Senior FA Partner advances consistent, compliant, and high-quality faculty affairs operations in support of the College's mission and strategic priorities.
Associate Director, US Strategic Business Planning & Execution, Medical Affairs AstraZeneca PlcAssociate Director, US Strategic Business Planning & Execution, Medical AffairsBoston, MA$150,098.40–$225,147.60 / yearThis is what you will do: The Associate Director Strategic Planning & Execution, US Medical Affairs is responsible for the execution of strategic initiatives within the US Medical Affairs organization and will partner with TA Leadership teams and cross functionally to execute on projects in line with the functions overall strategic goals. You will be responsible for: Strategic Partnership: Develop annual enterprise strategy for assigned TA and/or Function and ensure effective, efficient, and equitable delivery of key strategic programs and operational activities.
Provost and Vice President for Academic Affairs Springfield CollegeProvost and Vice President for Academic AffairsSpringfield, MA$250,000–$265,000 / yearThis leader will shape the future of Springfield College by aligning academic priorities with market demand, strengthening faculty excellence, and ensuring that the Humanics philosophy continues to differentiate the institution in a rapidly evolving higher education landscape. Lead Academic Strategy and Portfolio Alignment: Drive the implementation of the Strategic Plan, ensuring academic programs align with student demand, workforce needs, and institutional priorities.
Senior Director, Regulatory Affairs CMC – Biologics Beeline MedicinesSenior Director, Regulatory Affairs CMC – BiologicsBoston, MassachusettsDemonstrate entrepreneurial drive and resourcefulness in executing CMC regulatory responsibilities — proactively seek out information, build relationships across the CMC organization, and find creative avenues to get things done; a successful CMC regulatory lead takes ownership of being plugged in, earns trust within the team, and removes barriers through initiative and ownership. Act as a fully integrated partner within the CMC team, attending key technical meetings, engaging daily with Process Development, Analytical, Manufacturing Sciences, Drug Supply and Quality colleagues, and translating regulatory strategy into practical guidance that enables the CMC team to make informed decisions and move programs forward with regulatory confidence.
Senior Medical Director , US Immunology Medical Affairs Swedish Orphan Biovitrum ABSenior Medical Director , US Immunology Medical AffairsBoston, MA$260,000–$295,000 / yearDevelop and foster strong collaborative relationships with internal partners, including Regulatory Affairs, Clinical Operations, Market Access, Medical Information, Pharmacovigilance, Sales and Marketing, Global product leadership, Global medical affairs, and clinical development, providing strategic medical insight and product/disease-state expertise to meet business objectives. Additionally, the Senior Medical Director will be a key contributor to the global life cycle management-led activities, including programs for future indications, cytokine testing, Investigator-Initiated Study strategy, and overall input into the creation and execution of product evidence generation plans.
Director, Scientific Communication and Operations, Medical Affairs Kymera TherapeuticsDirector, Scientific Communication and Operations, Medical AffairsWatertown, MA$195,000–$275,000 / yearThe Director Scientific Communication and Operations, Medical Affairs, reporting into the Vice President, Medical Affairs, is a strategic leader responsible for developing and executing Medical Affairs strategy across Medical Affairs Scientific Communications and Operations, spanning data generation and dissemination, scientific publications, medical-to-medical content development, and field medical training materials, as well as operational planning, congress planning, grants and sponsorships, cross-functional coordination, and advisory boards. This role will work cross-functionally with internal stakeholders (R&D, Commercial, Regulatory, etc.) and externally with healthcare professionals, key opinion leaders (KOLs), and scientific organizations to ensure impactful and compliant medical engagement and education aligned with corporate objectives.
Manager, Regulatory Affairs Relay Therapeutics, Inc.Manager, Regulatory AffairsCambridge, MABuilt on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. Your Role: You will work closely with research and development colleagues to support the development and execution of innovative regulatory strategies for programs ranging from first-in-human through late-stage clinical development, including the implementation of non-clinical and clinical regulatory strategy.
Head of Medical Affairs AVEO Pharmaceuticals IncHead of Medical AffairsBoston, MAREQUIRED QUALIFICATIONS/EXPERIENCE (BASIC QUALIFICATIONS): • Advanced Scientific or Medical degree (s), MD preferred • Demonstrated substantial Medical expertise in Oncology through clinical, research, and business activities • Minimum of 7 years of experience in medical affairs, with 5 years as an MSL in industry; at least 2 years of experience managing an MSL team • Demonstrated success in building effective teams, systems, and processes; proven ability to identify, select and manage a variety of external resources related to execution of medical affairs functions • Ability to lead a team of functional experts and negotiate the multi-disciplinary environment in which they operate • Strategic and analytical thinking with the ability to contribute to the plan and design effective medical affairs brand and life cycle strategies • Strong understanding of industry and regulatory guidelines pertinent to compliant interactions with external audiences • Demonstrated ability to comprehend complex scientific, medical, and relevant business issues and respond with actionable strategies and tactics to effectively produce timely and measurable results • Excellent written and verbal communication skills, exceptional listening skills, strong presentation skills, and good negotiating and influencing skills. JOB SUMMARY: Reporting to the CEO/CMO, the Head of Medical Affairs will serve as the functional manager and leader of the Field-based Medical Science Liaison team and provide strategic input into key medical affairs activities, including consistent and aligned medical and scientific communications, cross-functional medical strategy, development and execution of Advisory Boards, KOL and other key customer identification and engagement, publication strategy and planning, CME topics of interest and grant administration, and fostering relationships with key societies, physician networks, oncology cooperative groups and academic institutions.
Medical Affairs Lead - Osteoarthritis Formation BioMedical Affairs Lead - OsteoarthritisBoston, MA$325,000–$425,000 / yearRecognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines to patients.
Senior Manager- Knowledge Management for Clinical Affairs Integrated Resources, IncSenior Manager- Knowledge Management for Clinical AffairsCambridge, MassachusettsContractorJob DescriptionJob Title: Senior Manager – Knowledge Management for Medical AffairsDuration: 14+ MonthsLocation: Cambridge, MAResponsibilities:Gathering end user requirements from key stakeholders and review of technical specifications for information governance in partnership with IT, maintaining of critical functionality of the CRM platform to ensure uninterrupted access by HCPs to company product information;Creation and maintenance of all metrics and analytic tools necessary for supporting GMA decision making and maintenance of the content management system used by Worldwide Medical. Project management expertise with focus on driving for results and sense of urgencyMinimum of 7-10 years clinical data systems experience working in the biotechnology or pharmaceutical industryExperience applying best practices in application development to the clinical trial environment, including requirements definition and QC plansAware of current global regulatory guidelines relevant to Clinical Data Management, as well as related Pharma Development SOPs, guidelines and Best Practices.
Senior Manager, Corporate Affairs Stoke Therapeutics IncSenior Manager, Corporate AffairsBedford, MA$162,000–$212,000 / yearManage all social media channels including content development, oversight and evaluation of performance; recommend ongoing improvements based on metrics; manage external agency partners and budgets; and provide strategic direction. Position Purpose: The Senior Manager, Corporate Affairs will be responsible for leading content strategy, execution and campaign management across Stoke's corporate digital and social media platforms and channels.
Senior Manager, Corporate Affairs Stoke Therapeutics, Inc.Senior Manager, Corporate AffairsBedford, MA$162,000–$212,000 / yearManage all social media channels including content development, oversight and evaluation of performance; recommend ongoing improvements based on metrics; manage external agency partners and budgets; and provide strategic direction. Position Purpose: The Senior Manager, Corporate Affairs will be responsible for leading content strategy, execution and campaign management across Stoke's corporate digital and social media platforms and channels.
NewDirector/Senior Director, Medical Affairs Analytics & Systems Stoke Therapeutics IncDirector/Senior Director, Medical Affairs Analytics & SystemsBedford, MARemote$180,000–$253,000 / yearPosition Purpose: The Director/Senior Director, Medical Affairs Analytics & Systems will lead the systems, data, and analytics capabilities that enable Medical Affairs to operate efficiently and support timely, data-informed decision-making. Using Stoke's proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach, Stoke is developing antisense oligonucleotides (ASOs) to selectively restore naturally-occurring protein levels.
Senior Director, State Government Affairs Beam Therapeutics IncSenior Director, State Government AffairsCambridge, MA$260,000–$320,000 / yearBeam's suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This individual will be responsible for building a variety of strong, meaningful networks at the state level (including State Medicaid officials, state legislators and state policy stakeholders) and staying current on critical policy issues.
Senior Director, Medical Affairs Research & Operations Viridian Therapeutics IncSenior Director, Medical Affairs Research & OperationsWaltham, MAThis individual will set direction for scalable Medical Affairs capabilities across budgeting and forecasting, project and portfolio execution, performance reporting/KPI frameworks, SOP and process governance, audit readiness, sponsorships/congress oversight, ISR operations, and collaborative study management. Set the strategy and governance for and operationalize Medical Affairs performance reporting, Medical Affairs dashboards, KPI tracking, and achievement reporting to support leadership visibility and data-driven decision-making.
Senior Medical Science Liaison - Gene Therapy US Medical Affairs Orchard TherapeuticsSenior Medical Science Liaison - Gene Therapy US Medical AffairsBoston, MARemote$190,000–$240,000 / yearDevelop a territory profile including Centers of Excellence, key expertise, newborn screening approaches and leaders, and market access pathways to inform medical strategy and tactical planning in collaboration with our Commercial, Diagnostic, and Patient Advocacy partners. As a field-based member of the medical affairs team, the Sr MSL will be responsible for developing and enhancing professional relationships with external thought leaders involved in all phases of the clinical development process through a fair-balanced and high-value exchange of clinical and scientific information.
NewDirector Global Medical Affairs Technology Alnylam Pharmaceuticals IncDirector Global Medical Affairs TechnologyCambridge, MA$187,400–$253,600 / yearPartner on intake, prioritization, and cross-functional delivery for Medical Affairs technology investments, working with Medical Operations & Insights and other Medical Affairs stakeholders to translate business needs into platform capabilities, roadmap decisions, and measurable releases that improve user experience, operational efficiency, and business outcomes. Define and govern the Medical Affairs data strategy in partnership with Data & AI, including data ingestion, integration, reusable data assets, governed access, analytics enablement, and measurement frameworks that support medical insights generation, longitudinal analysis, RWE, and decision support.
Research Affairs Specialist - School of Dental Medicine Tufts UniversityResearch Affairs Specialist - School of Dental MedicineBoston, MAThe main function of the role is performing regulatory approval functions which includes working with study teams to develop study protocols, consent forms, and supporting documentations, facilitating IRB approval, study start-up activities, and monitoring study progress. Work with study teams to obtain start up approval for non-human subject research projects and survey studies, including review of study protocols, creation of recruitment supporting documentation, ensuring all study team members have CITI/GCP training.
Associate Director, R&D Quality Regulatory & Risk Integration Vertex Pharmaceuticals IncAssociate Director, R&D Quality Regulatory & Risk IntegrationBoston, MA$160,600–$240,800 / yearThe role partners closely with Global Regulatory Intelligence & Surveillance functions, RDQ leadership, Quality System Owners, Regulatory Affairs, and other cross-functional stakeholders to ensure emerging regulatory expectations, inspection trends, enforcement actions, and industry signals are proactively translated into actionable RDQ risk, governance, and operational activities. This individual will serve as the RDQ Regulatory Intelligence Champion (RIC) within enterprise Regulatory Intelligence forums and Centers of Excellence and will represent the Regulatory Intelligence Quality System within RDQ governance forums including the RDQ Quality Leadership Team (QLT), Quality Management Review (QMR), Monthly Risk Review Forum, and operational governance meetings.
Associate Director, Regulatory Science Orchard TherapeuticsAssociate Director, Regulatory ScienceBoston, MA$190,000–$240,000 / yearThe actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications), job-based knowledge, location, and other business and organizational needs. Orchard Therapeutics, a Kyowa Kirin company, is a global gene therapy leader focused on transforming the lives of patients with rare disorders through innovative gene therapies based on gene-modified hematopoietic stem cells (HSCs).
Manager of Regulatory Compliance Signature HealthcareManager of Regulatory ComplianceBrockton, MAConducting detailed data analysis to identify trends, risks, and areas for improvement in regulatory compliance and patient safety, the Manager utilizes data to inform decision-making and develop actionable insights related to accreditation and payor contracts. We believe our distinctive Signature Healthcare team approach is the way healthcare should be: medical professionals across many locations communicating and collaborating, taking advantage of technologies and resources to make a difference in the lives and health of our patients.
NewGroup Director Regulatory Process- Cell Therapy AstraZeneca PlcGroup Director Regulatory Process- Cell TherapyWaltham, MA$186,232.80–$279,349.20 / yearOur globally connected community blends cutting-edge technology with deep disease expertise, embraces data and automation to reduce cycle times, and thrives on collaboration that turns complex challenges into concrete outcomes for patients. This role supports high-impact programs across cancer, immune-mediated and rare diseases, guiding regulatory delivery and project management for projects spanning early development through licensure.
Director, Regulatory Affairs CMC Madrigal Pharmaceuticals IncDirector, Regulatory Affairs CMCWaltham, MA$207,000–$253,000 / yearThis role provides strategic, tactical and operational regulatory CMC leadership to support clinical trial applications, market registrations and post-approval submissions, along with managing the day-to-day regulatory CMC activities of assigned projects for development and/or commercial products. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process.
Director Regulatory Sciences Technology Alnylam Pharmaceuticals IncDirector Regulatory Sciences TechnologyCambridge, MA$187,400–$253,600 / yearLead the delivery, support, and continuous improvement of Regulatory Sciences technology platforms (e.g., regulatory information management, safety systems, document and submission platforms), providing hands-on technical leadership and architectural guidance to ensure solutions are scalable, compliant, and audit-ready. Success in this role requires a combination of strong Regulatory Sciences business acumen and deep technical fluency across regulated platforms, data integration, and document‑centric workflows, enabling the organization to operate at global scale while meeting evolving regulatory expectations.
Director, Regulatory CMC Rhythm Pharmaceuticals IncDirector, Regulatory CMCBoston, MA$182,000–$275,000 / yearAs part of the growing and dynamic regulatory affairs team, this role is accountable for the effective management and timely delivery of CMC regulatory documents, coordination of cross-functional inputs, and support of regulatory CMC execution activities across development, commercialization, and lifecycle management. Author, compile, review, and finalize high-quality CMC regulatory documents and submissions, including core dossiers, INDs, IMPDs, MAAs, BLAs, variations, and annual reports, in collaboration with internal and external stakeholders.
Senior Regulatory Consultant - Advertising & Promotion (Strategic Lead) Parexel International CorpSenior Regulatory Consultant - Advertising & Promotion (Strategic Lead)MAAs a result, we are seeking an additional highly strategic and experienced Senior Regulatory Consultant - Advertising & Promotion to serve as a trusted advisor across cross-functional teams on this dedicated client partnership. This role extends beyond execution, requiring a proactive leader who can independently review materials, interpret evolving FDA guidance, and pivot regulatory strategy to support business objectives while mitigating risk.
NewAssociate Director, Regulatory CMC, Biologics Vertex PharmaceuticalsAssociate Director, Regulatory CMC, BiologicsBoston, Massachusetts$166,400–$249,600 / yearThe Chemistry Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies across investigational and commercial products focusing on biologics. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.
Director, Regulatory CMC Genetix BiotherapeuticsDirector, Regulatory CMCSomerville, Massachusetts$204,000–$245,000 / yearThe Director, Regulatory CMC is responsible for leading execution of global CMC regulatory strategies for approved and late-stage gene therapy products, with a primary focus on lifecycle management, change management, and regulatory compliance. This role supports the development and delivery of post-approval regulatory strategies and ensures effective implementation of manufacturing, analytical, and control changes across global markets.
Director, Regulatory Labeling Strategy (Remote-Eligible) Vertex PharmaceuticalsDirector, Regulatory Labeling Strategy (Remote-Eligible)Boston, MassachusettsRemote$185,600–$278,400 / yearLeads label working groups (LWG) and represents labeling at product-specific global regulatory teams and senior labeling governance meetings: Label Review Group (LRG) and Executive Label Review Group (ELRG). Lead labeling strategy with expert ability to advise stakeholders of regulatory labeling requirements and provide oversight of health authority interactions (responses to questions, negotiations, and inspections) regarding all aspects of labeling.
Regulatory Strategist SanofiRegulatory StrategistCambridge, MA$148.50–$214.50 / hourAs a key member of the Global Regulatory Team (GRT) and strategic partner to the Global Regulatory Lead (GRL), you will leverage your regulatory expertise to contribute to the definition of the global regulatory strategy and drive the execution of aligned US, EU, and/or global regulatory strategies for assigned projects, including Health Authority (HA) interactions. Supports operational and compliance activities for assigned deliverables, develops, executes regulatory submission planning activities, including generating submission content plans, submission tracking, and document management utilizing the support and input of cross-functional team and/or alliance partners where relevant.
Head Of Regulatory Examinations Management, MD State Street CorporationHead Of Regulatory Examinations Management, MDBoston, MA$170,000–$267,500 / yearThe Global Head of Regulatory Examination Management is a senior leadership role within the Global Regulatory Liaison Office (GRLO) responsible for leading the firm's global regulatory examination program, including the governance, coordination, and execution of supervisory reviews across jurisdictions. Our GRLO serves as the primary liaison with regulators in jurisdictions in which we operate and is responsible for strategically managing those relationships through a global operating model that supports local, regional and global needs consistently.
Sr. Director, Regulatory Labeling and Advertising Promotion Genetix BiotherapeuticsSr. Director, Regulatory Labeling and Advertising PromotionSomerville, Massachusetts$238,000–$294,000 / yearThe position serves as a key regulatory partner to Clinical Development, Medical Affairs, Commercial, Legal, and Safety, and plays a central role in labeling strategy, lifecycle management, and promotional material review in a highly regulated environment, for cell and gene therapy products. Actual base salary pay will be based on several factors, including but not limited to experience, skills, relevant education/qualifications, external market, internal equity, and other job-related factors permitted by law.
Head of Regulatory Examinations Management, MD State Street CorpHead of Regulatory Examinations Management, MDBoston, MA$170,000–$267,500 / yearThe Global Head of Regulatory Examination Management is a senior leadership role within the Global Regulatory Liaison Office (GRLO) responsible for leading the firm's global regulatory examination program, including the governance, coordination, and execution of supervisory reviews across jurisdictions. Our GRLO serves as the primary liaison with regulators in jurisdictions in which we operate and is responsible for strategically managing those relationships through a global operating model that supports local, regional and global needs consistently.
Director, Patient Experience & Regulatory Engagement AstraZeneca PlcDirector, Patient Experience & Regulatory EngagementBoston, MAProvides strategic leadership across cross-functional teams and patient community stakeholders to generate patient experience data (PED)-including patient preference, patient-generated, and lived-experience evidence ultimately shaping patient‑informed risk/benefit narratives to support external stakeholder interactions. Increasingly global regulators, and decision makers such as HTA bodies and payors recognize the value of lived patient experience data (PED) to inform therapeutic development regulatory decision-making in line with guidance including patient-focused drug development, while supporting coverage and access decisions that can improve real-world outcomes.
Senior Director, US Regional Regulatory Lead Les Laboratoires Servier SASSenior Director, US Regional Regulatory LeadBoston, MARemote$232,000–$284,000 / yearAs a key member of the Global Regulatory Team (GRT) and strategic partner to the Global Regulatory Lead, the Senior Director, US Regional Regulatory Lead (US RRL) contributes to innovative, label focused, aligned US and global development plans. Collaborate with and influence the GRT for assigned projects in alignment with the teams one regulatory voice, providing strategic input on the Target Product Profile (TPP), Company Core Data Sheet (CCDS), business planning, governance, and committees.
NewAssociate Director / Director, Medical Information Cognito TherapeuticsAssociate Director / Director, Medical InformationCambridge, MAPartner closely with Medical Affairs, Field Medical, Scientific Communications, Clinical Development, Pharmacovigilance/Drug Safety, Quality, Commercial, Market Access, Patient Support, and other functions to support compliant scientific exchange and launch readiness. Serve as the internal subject matter expert on MI best practices, regulatory expectations (FDA, EMA/MDR/Notified Bodies), and industry benchmarks for neurocognitive disease and advanced therapies.
Director, Regulatory Strategy Vertex PharmaceuticalsDirector, Regulatory StrategyBoston, Massachusetts$196,800–$295,200 / yearRepresents GRA on core development functional teams, project teams, and collaborate with regional leaders and teams to ensure unified regulatory input into clinical programs and commercial strategy. Addresses complex issues, providing innovative regulatory solutions and guidance to cross-functional teams and align communication to and from cross-functional teams, GRA functional team and GRA leadership.
Clinical Imaging Scientist, Translational Radiology AstraZeneca PlcClinical Imaging Scientist, Translational RadiologyWaltham, MA$203,709.60–$305,564.40 / yearExperience functioning as the Imaging subject matter expert working with clinical development teams (evidence of leading cross functional teams focusing on good communication, passion for customers and working collaboratively). Understanding of the Blinded Independent Centralized Review process at external imaging CROs, including common review paradigms, radiologist reviewer analysis application and eCRFs, and operational and regulatory documents including Independent Review Imaging Charters.
Medical Director, Medical Affairs Beeline MedicinesMedical Director, Medical AffairsBoston, MassachusettsLead and conduct peer-to-peer scientific exchange with KMEs, investigators, and HCPs together with the development team— sharing clinical and emerging data, discussing unmet medical needs, and gathering external insights (such as in depth knowledge of the patient journey from diagnosis to treatment along with barriers that are encountered along the way) that inform medical strategy, pipeline positioning, and commercial readiness. Partner with Field Medical Affairs and MSL teams to ensure accurate, balanced, and up-to-date scientific tools and resources are available and consistently applied in field engagements — participating directly in key field interactions when the scientific complexity or stakeholder importance warrants senior medical presence.
Regulatory & Clinical Specialist LivaNova PlcRegulatory & Clinical SpecialistBoston, MARemote$85,000–$95,000 / yearManage the overall development and approval process for assigned documents (CEP, CER, etc.) within timelines, including documentation generation, initiation of the review process, discussions on proposed revisions, and document completion in collaboration with other team members. If you are concerned that an offer of employment might be a scam or that the recruiter is not legitimate, please verify by searching for "See Open Jobs" on https://www.livanova.com/en-us/careers , and check that all recruitment emails come from an @livanova.com email address.
Regulatory Strategy Director Vertex Pharmaceuticals IncRegulatory Strategy DirectorBoston, MA$196,800–$295,200 / yearRepresents GRA on core development functional teams, project teams, and collaborate with regional leaders and teams to ensure unified regulatory input into clinical programs and commercial strategy. Addresses complex issues, providing innovative regulatory solutions and guidance to cross-functional teams and align communication to and from cross-functional teams, GRA functional team and GRA leadership.
Director, US Advertising and Promotional Compliance AstraZeneca PlcDirector, US Advertising and Promotional ComplianceBoston, MA$193,281–$289,922 / yearWe operate with the focus of a nimble biotech and the reach of a global biopharma, bringing unexpected teams together to spark bold thinking that turns complex biology into meaningful patient impact. The Director will also engage business partners for strategic planning on issues pertaining to product promotion and will participate in developing processes and procedures relevant to the creation, review and approval of promotional material.