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.
JobotNewVice President Clinical Development Ophthalmology JobotVice President Clinical Development OphthalmologyBoston, MA$350,000–$400,000 / yearInformation collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. 4. Collaborate with cross-functional teams including regulatory affairs, pharmacovigilance, and medical affairs to ensure a holistic approach to product development.
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.
Careers Integrated Resources IncAssociate Project Manager Careers Integrated Resources IncAssociate Project ManagerMarlborough, MA$50–$70 / hourThe projects will vary in size and Product but may include supporting Quality/Regulation driven projects, supporting material or supplier changes, executing product extensions, executing value improvement projects or product design enhancements. Additionally, you will engage with functional managers to manage the portfolio of sustaining projects for your business unit and align projects priorities and resources needs to execute successfully the sustaining strategy.
UMass Memorial HealthDivision Chief-Academic Specialists in General Obstetrics & Gynecology, UMass Memorial Medical Group UMass Memorial HealthDivision Chief-Academic Specialists in General Obstetrics & Gynecology, UMass Memorial Medical GroupWorcester, MAWhere relevant, oversee or collaborate with specialty sections such as Pediatric & Adolescent Gynecology, Complex Family Planning, and Complex Benign Gynecology/Minimally Invasive Gynecologic Surgery, and other subspecialty divisions including Maternal-Fetal Medicine, Gynecologic Oncology, Reproductive Endocrinology and Infertility, and Urogynecology. The largest division in the Department, including academic specialists in general obstetrics and gynecology, family planning specialists, complex benign gynecology/minimally invasive gynecologic surgery specialists, pediatric and adolescent gynecology specialists, and advanced practice clinicians.
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.
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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").
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.
DeephealthSr Regulatory Affairs Principal Autonomous DeephealthSr Regulatory Affairs Principal AutonomousSomerville, Massachusetts$133,000–$165,000 / yearLead and manage regulatory submissions, including FDA Q-submission, US 510(k)s submissions, Premarket Approvals (PMA) submissions, supplements, and reports, including Regulatory Body interactions. Regulatory Affairs Principal is responsible for developing and executing regulatory strategies, ensuring compliance with global regulations and leading the process to obtain and maintain market approval for DeepHealth’s high risk products, including AI technologies.
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.
ParexelNewSenior Regulatory Affairs Consultant - Regulatory Intelligence (Talent Pool) ParexelSenior Regulatory Affairs Consultant - Regulatory Intelligence (Talent Pool)Boston, MARemoteLead the client's internal process to obtain and coordinate SME impact assessments/comments, facilitate comment collection/assimilation, and help develop company messaging to share either with PhRMA working groups or directly with Health Authorities. In this consultative role, you will combine regulatory expertise, analytical rigor, and strong project leadership skills to navigate an evolving regulatory landscape while collaborating closely with clients, internal experts, and global teams.
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.
CEDENTRegulatory Affairs Specialist CEDENTRegulatory Affairs SpecialistBoston, MAComfortable working directly for regulatory agencies, including the Food and Drug Administration (FDA), DEA, and Boards of Pharmacies. The Regulatory Affairs Specialist will be responsible for regulatory documentation, compliance, requirements, submissions, and overall regulatory affairs activities.
ConfidentialNewSenior Vice President, Global Regulatory Affairs ConfidentialSenior Vice President, Global Regulatory AffairsBoston, MASenior Vice President, Global Regulatory AffairsAbout the CompanyPioneering biotechnology company specializing in precision oncology therapeuticsIndustryBiotechnologyTypePrivately HeldAbout the RoleThe Company is in search of a Senior Vice President for Global Regulatory Affairs to spearhead the regulatory vision for its innovative oncology therapeutics. The SVP will also be responsible for building and mentoring a high-performing global regulatory team, establishing regulatory systems and processes, and ensuring inspection readiness and compliance as the organization progresses toward pivotal trials.
ConfidentialNewVice President and Senior Vice President, Global Regulatory Affairs ConfidentialVice President and Senior Vice President, Global Regulatory AffairsBoston, MAVice President and Senior Vice President, Global Regulatory AffairsAbout the CompanyEsteemed biotechnology company developing next-generation precision oncology therapeuticsIndustryBiotechnologyTypePrivately HeldAbout the RoleThe Company is in search of a Vice President/Senior Vice President for Global Regulatory Affairs to lead the regulatory vision for its late-stage oncology pipeline. The role demands a leader with a successful history in accelerated and expedited pathways, including FDA and EMA interactions, and experience in leading regulatory strategy for programs involving novel biomarkers, diagnostics, or patient-selection tools.
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.
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.
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.
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.
AVEO Pharmaceuticals IncExecutive Director, Regulatory Affairs AVEO Pharmaceuticals IncExecutive Director, Regulatory AffairsBoston, MAExecutive Director, Regulatory Affairs - Boston, MA Skip To Content. Skip to content Main Navigation.
Whoop IncQuality Systems & Regulatory Affairs Specialist Digital Health Whoop IncQuality Systems & Regulatory Affairs Specialist Digital HealthBoston, MA$144,000–$197,000 / yearAt WHOOP, we view total compensation as the combination of base salary, equity, and benefits, with equity serving as a key differentiator that aligns our employees with the long-term success of the company and allows every member of our corporate team to own part of WHOOP and share in the company's long-term growth and success. Strong written, oral, organization, problem solving, and interpersonal skills to effectively compose regulatory submissions, support audit backrooms, and complete assignments with minimal supervision.
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.
Northeastern UniversityPart-Time Lecturer - Regulatory Affairs (Boston) Northeastern UniversityPart-Time Lecturer - Regulatory Affairs (Boston)boston, MAWe are looking for a qualified candidate to teach on-campus graduate-level courses for the Master of Science in Regulatory Affairs of Drugs, Biologics, and Medical Devices and/or graduate certificate programs in Domestic, International, or Medical Device Regulatory Affairs. The College of Professional Studies at Northeastern University invites applications for a non-tenure track part time faculty lecturer in Regulatory Affairs on the Boston campus.
DeephealthSr. Regulatory Affairs Spclst DeephealthSr. Regulatory Affairs SpclstSomerville, Massachusetts$120,000–$165,000 / yearRegulatory 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.
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.
Zoll Data Systems, Inc.Senior Regulatory Affairs Program Specialist Zoll Data Systems, Inc.Senior Regulatory Affairs Program SpecialistChelmsford, MARemoteThe Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Evaluate and resolve regulatory and technical issues due to extensive knowledge of medical device manufacturing and related regulatory requirements in this product sector through a clear understanding of the product development lifecycle.
Beam TherapeuticsSpecialist I/II, Regulatory Affairs Beam TherapeuticsSpecialist I/II, Regulatory AffairsCambridge, MA$130,000–$160,000 / yearParticipate in regulatory intelligence activities, monitor regulatory guidelines and trends as they pertain to global regulations and guidance, and provide regulatory advice to project teams regarding the applicability/impact on internal programs; anticipate and communicate possible regulatory paradigm shifts. Beam'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.
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.
DeephealthSr Regulatory Affair Principal DeephealthSr Regulatory Affair PrincipalSomerville, Massachusetts$130,000–$160,000 / yearLead and manage regulatory submissions, including FDA Q-submission, US 510(k)s submissions, Premarket Approvals (PMA) submissions, supplements, and reports, including Regulatory Body interactions. Regulatory Affairs Principal is responsible for developing and executing regulatory strategies, ensuring compliance with global regulations and leading the process to obtain and maintain market approval for DeepHealth’s high risk products, including AI technologies.
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.
ModivCare Inc.Regional Government Affairs Director - Northeast ModivCare Inc.Regional Government Affairs Director - NortheastWorcester, 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.
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.
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.
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.
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).
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.