Agios PharmaceuticalsSenior Director, Global Scientific Communications and Publications - Remote Agios PharmaceuticalsSenior Director, Global Scientific Communications and Publications - RemoteBoston, MARemote$229,562–$344,342 / yearThe role oversees a high-impact team and partners cross-functionally and externally to drive an integrated publications and scientific communications strategy, translating complex data into compelling evidence that supports clinical adoption, informs healthcare decision-making, and differentiates the company’s portfolio globally. Agios Pharmaceuticals is searching for a dynamic Senior Director, Global Scientific Communications and Publications expert to join our Global Medical Affairs team and lead a high-functioning communications/publications/congress team.
AtriumNewClinical Research Medical Director (Part-Time) AtriumClinical Research Medical Director (Part-Time)Westport, 02790, MAThe organization partners with healthcare professionals, research teams, and sponsors to deliver high-quality clinical research while maintaining a strong focus on patient safety and regulatory compliance. Candidates who apply for roles through the Atrium website will be added to our candidate pool and may be considered for additional roles of a similar title.
Dentsply SironaNewSenior Director, Clinical Education and Events Dentsply SironaSenior Director, Clinical Education and EventsBoston, MAThis leader serves as the senior clinical authority for NAM education, ensuring programs meet the needs of practicing clinicians while supporting business priorities, product adoption, and long term customer trust. • Oversee planning and execution of clinical educational events (e.g., courses, workshops, symposia, webinars), ensuring end-to-end operational excellence (logistics, faculty coordination, attendee experience) and alignment to learning objectives.
CSL SeqirusNewAssociate Director, Clinical Assay Strategy, Flu CSL SeqirusAssociate Director, Clinical Assay Strategy, FluWaltham, MA$179,000–$212,000This role is intended for a recognized subject matter expert who understands the scientific, operational, and regulatory evolution of influenza immunogenicity assessment, including HAI, microneutralization (MN), ELLA, and multiplex platforms, and can strategically navigate assay modernization while maintaining regulatory alignment. Headquartered in Melbourne, Australia, with major manufacturing hubs in Holly Springs, NC, and Liverpool, UK, the company operates the world’s largest cell-based vaccine facility and serves as a primary partner to governments for global pandemic preparedness.
Monte Rosa Therapeutics, IncDirector, Regulatory Affairs – Global Regulatory Strategy Monte Rosa Therapeutics, IncDirector, Regulatory Affairs – Global Regulatory StrategyBoston, MassachusettsOverview: Monte Rosa Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our development programs, with a focus on immunology. Lead the preparation, submission, and maintenance of regulatory applications, including INDs, CTAs, marketing applications, Annual Reports, Orphan Drug Designation, Requests for Fast Track, and other regulatory documents.
Kymera TherapeuticsDirector, Regulatory Affairs Kymera TherapeuticsDirector, Regulatory AffairsWatertown, MA$160,000–$275,000 / 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. As a critical member of a growing RA organization, this role will leverage their recent and relevant hands-on experiences developing immunology treatments to help rapidly advance Kymera's I/I portfolio of targeted protein degraders.
Monte Rosa Therapeutics IncDirector, Regulatory Affairs - Global Regulatory Strategy Monte Rosa Therapeutics IncDirector, Regulatory Affairs - Global Regulatory Strategyboston, MAQualifications Bachelor''s degree in health sciences or related field, or an advanced degree is preferred Minimum of 12 years of experience in global regulatory affairs within the pharmaceutical or biotechnology industry Global regulatory strategy experience is required, including direct involvement with US, EU and international regulatory submissions and strategy. Overview Monte Rosa Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our development programs, with a focus on immunology.
Azurity Pharmaceuticals - USDirector, Regulatory Affairs – Clinical Strategy Azurity Pharmaceuticals - USDirector, Regulatory Affairs – Clinical StrategyWoburn, MADevelopment and implementation of clinical regulatory strategies and tactics,including but not limited to, Modeling Informed Drug Development (MIDD), real- world data (RWD)/real-world evidence (RWE), and meta-analysis, for pipeline and commercial assets,while considering FDA and other health authority clinical and regulatory requirements. As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Director – Clinical Strategy will conduct in depth analysis of regulatory and clinical information to develop complex strategies supporting potential drug products for development and commercial drug products for expansion of the Azurity portfolio of medications.
Relay TherapeuticsAssociate Director, Regulatory Affairs Relay TherapeuticsAssociate Director, 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. You will work side by side with your regulatory and research and development colleagues to develop and execute innovative regulatory strategies for our fast-paced programs, including the implementation of non-clinical and clinical regualtory strategy for relevant products.
Avalyn PharmaSenior Manager / Associate Director, Regulatory Affairs Avalyn PharmaSenior Manager / Associate Director, Regulatory AffairsBoston, MA$163,000–$182,000 / yearThis is a critical role for a highly motivated regulatory leader with experience in rare disease drug development, combination products, and a proven track record of advancing programs from early stages through late-phase clinical development. Avalyn is reimagining the future of pulmonary fibrosis treatment with a pipeline of new inhaled formulations of approved medicines designed to reduce systemic exposure and deliver medication directly to the site of disease.
Rhythm PharmaceuticalsNewAssociate Director, Regulatory Affairs Rhythm PharmaceuticalsAssociate Director, Regulatory AffairsBoston, MAFull timeFor the right candidate, this role offers significant growth potential as you help shape the regulatory future of our rare disease programs and make a meaningful impact on patients' lives. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause.
Kura OncologyDirector, Regulatory Affairs Kura OncologyDirector, Regulatory AffairsBoston, MA$226,495–$258,817 / yearEnrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-mutant AML has been completed, and in the second quarter of 2025, the companies announced the FDA's acceptance of a New Drug Application for ziftomenib for the treatment of adult patients with R/R NPM1-mutant AML and assignment of a Prescription Drug User Fee Act target action date of November 30, 2025. Ziftomenib, a once-daily, oral menin inhibitor, is the first and only investigational therapy to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration ("FDA") for the treatment of relapsed/refractory ("R/R") NPM1-mutant acute myeloid leukemia ("AML").
Nova BiomedicalDirector, Regulatory Affairs Nova BiomedicalDirector, Regulatory AffairsWaltham, MA$210,000–$270,000 / yearOversees and leads the Regulatory Affairs function to ensure global regulatory requirements are met for Nova products including but not limited to: U.S. FDA 21 CFR Part 820 (Quality Management System Regulation (QMSR), ISO 13485:2016, EU Regulation (EU) 2017/746 (IVDR); UK Medical Devices Regulations 2002 (UK MDR 2002); Australian Therapeutic Goods (Medical Devices) Regulations 2002 (incl. Own post-market regulatory obligations, including vigilance/adverse event reporting, Field Safety Corrective Actions/recalls (as applicable), regulatory reporting, and support for post-market performance follow-up and performance evaluation report updates under IVDR, as well as post-market surveillance and vigilance requirements under UK MDR 2002.
Takeda PharmaceuticalNewDirector, Global Regulatory Affairs CMC Takeda PharmaceuticalDirector, Global Regulatory Affairs CMCBoston, MA$177,000–$278,080 / yearThis role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team's delivery of critical functions as follows: Independently develops the regulatory CMC strategy and leads the execution of regulatory CMC investigational, registration and post-approval strategies for their assigned product(s) as the GRA CMC Product Lead. Proactively communicates CMC regulatory strategies, key issues and risks through assigned programs / products development activities and LCM in adequate and timely manner to cross-functional programs/ products teams and management level within GRA CMC, GRA, PS, GMS and QA - as appropriate.
Takeda PharmaceuticalNewAssociate Director, Global Regulatory Affairs CMC Takeda PharmaceuticalAssociate Director, Global Regulatory Affairs CMCBoston, MA$154,400–$242,550 / yearProactively communicates CMC regulatory strategies, key issues and risks through assigned programs / products development activities and LCM in adequate and timely manner to cross-functional programs/ products teams and management level within GRA CMC, GRA, PS, GMS and QA - as appropriate. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team's delivery of critical functions as follows: With minimal supervision, develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products.
Hemab ApSDirector, Regulatory Affairs Hemab ApSDirector, Regulatory AffairsCambridge, MADemonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally proactively identifies regulatory issues offers creative solutions and strategies including risk mitigation strategies. You are a try partner to the Copenhagen-based team working hands-on in the day-to-day execution supporting cross-functional colleagues and ensuring momentum across programsQualifications & ExperienceBachelors degree in a scientific subject area coupled with sufficient industry experience.
Dyne Therapeutics IncExecutive Director, Regulatory Affairs Advertising & Promotion Dyne Therapeutics IncExecutive Director, Regulatory Affairs Advertising & PromotionWaltham, MARemoteActively participates in labeling and global regulatory team meetings to ensure support for anticipated promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it related to the use of study results in US and global promotion. • Maintains current awareness of evolving FDA regulations and interpretations, FDA advisory letters, enforcement letters, and policies issues affecting the pharmaceutical/biologics industry and communicates significant changes in FDA perspective to relevant stakeholders.
Takeda PharmaceuticalNewExecutive Director, Global Regulatory Affairs CMC Early Development Takeda PharmaceuticalExecutive Director, Global Regulatory Affairs CMC Early DevelopmentBoston, MA$238,000–$374,000 / yearLeads and develops a team of regulatory leaders and subject matter experts, overseeing global CMC regulatory strategy and key submissions/health authority interactions for an assigned portfolio of small molecule and biologic products through Phase 2. Partners with cross-functional leaders (CMC, Regulatory, Development, Clinical, Nonclinical, Quality, Safety, Manufacturing, Supply Chain, and Digital/Data) to align CMC development plans, to regional regulatory expectations and program timelines. As Executive Director, Global Regulatory Affairs CMC Early Development you will provide strategic leadership and development to global CMC regulatory subject matter experts to ensure innovative, robust, fit-for-phase regulatory strategies for small molecule and biologic products for FIH to pre-pivotal development, maximizing global regulatory success and minimizing time to clinical milestones.
Takeda Pharmaceutical Co LtdDirector, Global Regulatory Affairs, Neuroscience Takeda Pharmaceutical Co LtdDirector, Global Regulatory Affairs, Neuroscienceboston, MA$174,500–$274,230 / yearThe actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.\u202fThe actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
Takeda Pharmaceutical Co LtdAssociate Director, Global Regulatory Affairs - GI & Inflammation Takeda Pharmaceutical Co LtdAssociate Director, Global Regulatory Affairs - GI & Inflammationboston, MA$153,600–$241,340 / yearThe actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.\u202fThe actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. Demonstrates strong skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
AVEO OncologyExecutive Director, Regulatory Affairs AVEO OncologyExecutive Director, Regulatory AffairsBoston, MAThe Executive Director, Global Regulatory Affairs will provide strategic and operational leadership for global regulatory activities across the company’s oncology portfolio and will be accountable for the development and execution of integrated global regulatory strategies across the full product lifecycle, from early clinical development through registration, commercialization, and post‑approval lifecycle management. Ensure the preparation, review, and approval of high‑quality regulatory submissions and related documentation, including but not limited to INDs/CTAs, scientific advice packages, orphan drug applications, PIPs/PSPs, BLAs/MAAs, labeling strategy and negotiations, responses to regulatory questions, and post‑approval commitments.
Akebia TherapeuticsManager Regulatory Affairs, CMC Akebia TherapeuticsManager Regulatory Affairs, CMCCambridge, MA$139,672–$188,968As we expand our portfolio across early and late-stage programs, we are looking for a Manager, Regulatory Affairs CMC who will thrive in a team-oriented, solutions-focused environment and is looking to play a visible, hands-on role in shaping regulatory strategy and execution. Manage timelines and coordinate inputs across Technical Operations, Analytical, and Quality teams to ensure clear, consistent, and high-quality submissions using Regulatory eCTD templates.
Katalyst Healthcares and Life SciencesNewSenior Regulatory Affairs Manager Katalyst Healthcares and Life SciencesSenior Regulatory Affairs ManagerBoston, MADevelop global pediatric strategy; collaborate with regional leads on the content for regional pediatric plans (e.g., PIP); ensure global pediatric strategy is reflected in the Global Regulatory Plan; ensure any changes to CDP or Nonclinical development plans are assessed by regional leads for impact to pediatric plan agreements with Health Authorities. This includes formulating the global Nonclinical / Clinical strategy for the Global Regulatory Plan, acting as the key liaison with Health Authorities and leading the preparation of Nonclinical / Clinical documentation to support global regulatory filings, including post-approval activities and life-cycle expansion opportunities.
XRHealthDirector of Scientific Affairs XRHealthDirector of Scientific AffairsNeedham, MARemoteFull timeBeyond research execution, you will contribute to business strategy by identifying high-value grant opportunities that align with company growth priorities, and by engaging with strategic partners, academic institutions, and key opinion leaders to expand XRHealth’s reach and credibility. Query and analyze data from XRHealth’s centralized cloud-based Data Lake to evaluate treatment efficacy, utilization trends, and clinical outcomes across therapeutic areas (depression, anxiety, chronic pain, physical and neurorehabilitation).
Beam TherapeuticsManager/Senior Manager Regulatory Affairs – Advertising, Labeling, and Promotion Beam TherapeuticsManager/Senior Manager Regulatory Affairs – Advertising, Labeling, and PromotionCambridge, MA$130,000–$190,000 / 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. Serve as Regulatory lead for PRC/MLR review of promotional, disease awareness, scientific exchange, HCP, and patient-directed materials for certain products, under the supervision of the Director of Regulatory Labelling.
Vertex Pharmaceuticals IncMedical Affairs Senior Medical Director - Nephrology Vertex Pharmaceuticals IncMedical Affairs Senior Medical Director - Nephrologyboston, MA$240,000–$360,000 / yearExcellent understanding of government and industry guidelines, regulations, laws, etc., for appropriate scientific/medical exchange and communication with key external stakeholders (e.g., healthcare providers, payers, advocacy bodies). This role will work closely with a cross-functional group to ensure that scientific and medical strategies are aligned with broader corporate and key stakeholder needs and will ensure the flawless execution of Nephrology medical plans.
ModivCare Inc.Regional Government Affairs Director - Northeast ModivCare Inc.Regional Government Affairs Director - NortheastLynn, MA$159,900–$215,900 / yearThe position will design and implement state-level advocacy strategies aligned with enterprise priorities and will manage engagement with key stakeholders and execution of public affairs initiatives as directed and designed in collaboration with Corporate Affairs leadership. Serves as the companys primary representative at the assigned state capitols before executive leadership, including Medicaid directors, transportation program leaders, and personal care services (PCS) administrators.
Kymera TherapeuticsSenior Director, Medical Affairs, Respiratory Kymera TherapeuticsSenior Director, Medical Affairs, RespiratoryWatertown, MA$235,000–$330,000 / yearResponsibilities include building strong collaborative partnerships with asthma key opinion leaders (KOLs) and scientific organizations, providing medical and scientific expertise for portfolio indications, and supporting data generation and dissemination, scientific publications, and advisory boards. Having 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.
Formation Bio IncSenior Director, Medical Affairs Formation Bio IncSenior Director, Medical AffairsBoston, 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.
ConfidentialNewVice President of Regulatory Affairs ConfidentialVice President of Regulatory AffairsBoston, MAVice President of Regulatory AffairsAbout the CompanyWell-funded clinical-stage biotech companyIndustryBiotechnologyTypePrivately HeldAbout the RoleThe Company is seeking a Vice President of Regulatory Affairs to play a pivotal role in the advancement of a pipeline of therapeutics. The ideal background includes 15+ years of regulatory affairs experience, with a strong preference for direct experience in the FDA's pulmonology/pulmonary division and a proven track record in small biotech environments.
WerfenRegulatory Affairs Manager II Post Market WerfenRegulatory Affairs Manager II Post MarketBedford, MassachusettsLead field corrections and removal for on-market products, determining classification and regulatory agency reportability based on assessed risk, preparing comprehensive regulatory strategy, authoring field communication, leading cross-functional team to ensure timely customer notification, reporting and interfacing with regulatory agencies (as required), and supervising the regulatory team that assembles and maintains the necessary support records. This leadership role owns all elements related to post-market regulatory compliance to meet worldwide regulatory requirements, including vigilance reporting, recall (product correction and removal) management, on-market product change assessment, and the post-market surveillance (PMS) program.
ImCheck Therapeutics SASVIE - Senior Manager, Medical Affairs, Rare Disease ImCheck Therapeutics SASVIE - Senior Manager, Medical Affairs, Rare DiseaseBoston, MAServe as subject matter expert (SME) SME, on medical and/or disease area and asset cross-functional committees, as appropriateContribute to and lead advisory board planning and execution activities as assignedAs a SME, the candidate will be responsible to train internal Medical and cross-functional partners on disease area and Ipsen product contentContribute to the U.S. scientific publication planAttend relevant congresses to engage in scientific exchange and provide congress coverageSupport the planning, execution and budget oversight of medical activities relate to elafibranorManage Personal Travel and Expense budget in keeping with Ipsen guidelinesComplies with all laws, regulations and policies that govern the conduct of Ipsen U.S. staffQualificationsKnowledge & Experience (essential):Minimum of 5 years' relevant experience with at least 1-2 years in Medical Affairs with a strategic focus, including at least 2-3 years in the biotech/pharmaceutical industry. Main Responsibilities & Technical CompetenciesConduct medical review of promotional and non-promotional materials as a member of the Medical Review Committee (MRC) and Promotional Review Committee (PRC), ensuring medical & scientific accuracy and compliance with applicable U.S. laws, regulations, and company policies as neededParticipate in scheduled MRC and PRC meetings and contribute to discussions as neededAssist the Medical Communications Lead in the development of proactive and reactive field-facing materials (e.g., FAQs, objection handlers, advisory board content), incorporating input from field medical teams.
TechDigital CorporationProject Manager (Medical & Scientific Affairs) TechDigital CorporationProject Manager (Medical & Scientific Affairs)Danvers, MADescription/Comment: The Medical and Scientific Affairs function provides leadership and direction on medical, scientific and clinical decisions related to the overall Leica Biosystems business strategy. Partner with internal and external resources to deliver MSL and Medical Director effectiveness, Medical insights generation, and reporting on key projects.
Monte Rosa Therapeutics, IncManager, Regulatory Affairs Monte Rosa Therapeutics, IncManager, Regulatory AffairsBoston, MassachusettsResearches and analyzes regulatory information and determines acceptability of data, procedures, and other product-related documentation presented in support of product registration. Under supervision, compiles regulatory submissions, license renewal and annual registrations to the US Food and Drug Administration (FDA) and other regulatory agencies.
Katalyst Healthcares & Life SciencesNewSenior manager global regulatory affairs Katalyst Healthcares & Life SciencesSenior manager global regulatory affairsBoston, MAThis role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team's delivery of critical functions as follows: This role is within in the GRA Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team's delivery of critical functions as follows. RA CMC member on the Global Regulatory CMC team may act as the delegate for the GRA CMC Product Lead at Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle.
Beam TherapeuticsSenior Manager, Regulatory Affairs Beam TherapeuticsSenior Manager, Regulatory AffairsCambridge, MA$155,000–$190,000 / 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. In partnership and under guidance from the Regulatory Lead, drive the development of global regulatory strategy for Beam's portfolio of advanced genetic medicines and ensure integration of regulatory tactics that support the broader corporate strategy.
Third Rock Ventures LLCRegulatory Affairs Operations Manager Third Rock Ventures LLCRegulatory Affairs Operations ManagerCambridge, MAfor more information visit urlhttps://recruiting.paylocity.com/Recruiting/Jobs/Details/4004149.
AxonSenior Manager, Government Affairs, Northeast AxonSenior Manager, Government Affairs, NortheastBoston, MA$110,070–$176,112 / yearIn addition to the specific requirements listed below, the Senior Manager should be highly motivated, enjoy working in a fast-paced and often changing environment, have the ability to learn quickly, and be adept at setting priorities and anticipating needs. You will be a representative of Axon and lead meetings with state, city and county government officials to advance Axon's position with relevant government and law enforcement stakeholders, as well as to drive broader awareness and support for Axon's mission.
Akebia TherapeuticsDirector, Regulatory Labeling Akebia TherapeuticsDirector, Regulatory LabelingCambridge, MA$209,345–$283,232The successful candidate will be a strategic thinker who can translate complex regulatory frameworks into clear business impact, a strong influencer who is able to drive alignment across senior cross-functional stakeholders, be decisive and solutions-oriented, with the ability to navigate ambiguity and regulatory risk, have deep expertise in FDA labeling regulations and evolving global expectations, and be a collaborative leader who builds trust, fosters accountability, and elevates team performance. This individual will serve as the enterprise expert on labeling, partnering cross-functionally to ensure that product labeling is scientifically robust, commercially aligned, and compliant with evolving global regulatory requirements.
Bristol-Myers Squibb CoSenior Director, Global Regulatory Lead Neuroscience Bristol-Myers Squibb CoSenior Director, Global Regulatory Lead NeuroscienceCambridge Crossing, MA$258,680–$313,460 / yearWorking with regional regulatory staff as Global Regulatory Lead and US Regional Regulatory Lead on assigned development assets and marketed products:Develop global therapeutic regulatory strategies and operational plans for identified investigational and marketed products. Skills / RequirementsAdvanced degree in scientific discipline; MD, PhD or PharmD preferred, experience in neurology, neuromuscular diseases or neuropsychiatry drug development strongly preferred.8-12 years pharmaceutical industry experience, including 6-8 years in regulatory affairs.
The Steely GroupAssociate Director, Regulatory Operations The Steely GroupAssociate Director, Regulatory OperationsMalden, MSManage regulatory operations activities, including preparation of eCTD submission-ready documents, coordination across functions, and adherence to regulatory guidelines and processes. This role involves managing the preparation of eCTD submission-ready documents, coordinating across functions, and ensuring quality, accuracy, and adherence to regulatory guidelines.
AVEO OncologyNewExecutive Director, Regulatory Operations and Submission Management AVEO OncologyExecutive Director, Regulatory Operations and Submission ManagementBoston, MALead Regulatory Information Management (RIM) and publishing systems governance, acting as business owner for tools supporting submission planning/content management/publishing/archival and regulatory data integrity; partner with IT and Quality on validation, access controls, audit trails, change control, and vendor-managed services where applicable. · Serve as the operational submission execution partner to Regulatory Strategy and Regulatory CMC leads and cross‑functional teams, translating regulatory milestones into feasible operational plans, resourcing models, and publishing schedules while proactively identifying risks and mitigation strategies.
Vertex Pharmaceuticals IncRegulatory Strategy Senior Director Vertex Pharmaceuticals IncRegulatory Strategy Senior DirectorBoston, MAThis role will understand and translate regulatory, scientific, operational and business knowledge into effective implementation plans and strategy.\n \nThis is a Boston based, hybrid position requiring 3 days/week onsite.\n \nKey Duties & Responsibilities:\n\n Leads the development of regulatory strategy for multiple and/or complex projects in development (from first-in-human to post marketing application stage) outlined in Global Regulatory Strategy Documents including for regulatory submission documents and Health Authority communications\n Represents GRA on core development teams, project teams, and collaborate with regional leaders and teams to ensure unified regulatory input into clinical programs and commercial strategy\n Addresses complex issues, providing advanced regulatory solutions and guidance to cross-functional teams and align communication to and from cross-functional teams and GRA leadership. A strong leader who demonstrates sensitivity and understanding of cultural considerations, embraces diversity, and continuously develops staff by providing feedback, coaching, guidance and mentoring.\n \nRequired Education & Experience:\n\n Bachelor's degree in Biology, Chemistry, or other related discipline\n* Typically requires 12 years of relevant pharmaceutical or biotech industry experience within regulatory affairs and 5 years of supervisory/management experience, or the equivalent combination of education and experience\n \n#LI-TC1\n \n#LI-Hybrid\n \nPay Range:\n \n$232,000 - $348,000\n \nDisclosure Statement:\n \nThe range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting.
Orchard TherapeuticsSenior Medical Science Liaison - Gene Therapy US Medical Affairs Orchard TherapeuticsSenior Medical Science Liaison - Gene Therapy US Medical AffairsBoston, MARemote$190,000–$240,000Develop 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.
Connexion Systems + EngineeringNewRegulatory Strategy Director Connexion Systems + EngineeringRegulatory Strategy DirectorBoston, MA$100–$112 / hourKey ResponsibilitiesLead development of regulatory strategy for assigned programs across the full product lifecycle, from first-in-human through post-marketing stages, aligned with global regulatory strategy documents. We are seeking a Regulatory Strategy Director to lead the development and execution of innovative global and regional regulatory strategies across assigned development programs within a dynamic biopharmaceutical portfolio.
Takeda PharmaceuticalNewDirector, Global Regulatory Labeling Strategy Takeda PharmaceuticalDirector, Global Regulatory Labeling StrategyBoston, MARemote$177,000–$278,080 / yearConducts precedent searches, analyzes relevant competitor labeling, health authority labeling requests for Takeda products, labeling guidance and trends; and develops strategies and labeling language for inclusion assigned product labels (TLP, CCDS, USPI, EU SmPC, others as appropriate) to ensure consistency with the overall product strategy, product claims and information in the CCDS and to ensure that Takeda products have the most competitive labeling possible; while maintaining awareness of recent in-class approvals. In alignment with TAU/MPD Labeling Lead, coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee - GLOC) providing leadership to foster cross-functional collaboration and drive alignment of the labeling strategy and labeling content at all levels.
Rhythm PharmaceuticalsAssociate Director, Regulatory Operations Rhythm PharmaceuticalsAssociate Director, Regulatory OperationsBoston, MAFull timeAt Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause. This role involves managing the preparation of eCTD submission-ready documents, coordinating across functions, and ensuring quality, accuracy, and adherence to regulatory guidelines.
Takeda PharmaceuticalNewDirector, Global Regulatory Lead, GI & Inflammation Takeda PharmaceuticalDirector, Global Regulatory Lead, GI & InflammationBoston, MA$177,000–$278,080 / yearDemonstrates strong skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.