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.
Hebrew SeniorLifeNewMDS PPS Coordinator 40 hour Hebrew SeniorLifeMDS PPS Coordinator 40 hourDedham, MA$78,576.07–$117,864.10Provide on-going education to RSU staff regarding MDS compliance issues, maximization of appropriate reimbursement and Medicare program requirements. Educate unit staff regarding OBRA regulations, and serve as a resource regarding the policies and procedures of the skilled nursing facility.
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.
CSL SeqirusAssociate 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.
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.
BioNTechNewAssociate Director, Global Regulatory Affairs - Ad / Promo BioNTechAssociate Director, Global Regulatory Affairs - Ad / PromoCambridge, MAProvides input into labeling strategies for investigational and marketed products impacting potential US product promotion and is responsible for leading interactions with the FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotion Labeling Branch (APLB) pertinent to assigned brand(s). This position requires frequent interaction and strong collaboration with Commercial, Medical Affairs, Legal, Global Regulatory Affairs, Labeling and Compliance for the purpose of providing regulatory advice and guidance during promotional plan development all the way through to field implementation assuring conformity with FDA requirements, PhRMA DTC Guidelines and BioNTech policies.
Viridian Therapeutics IncAssociate Director Regulatory Affairs Viridian Therapeutics IncAssociate Director Regulatory AffairsWaltham, MAReporting to the Senior Director, Regulatory Affairs, the Associate Director, Regulatory Affairs will represent Regulatory Affairs on assigned cross-functional teams and lead day-to-day regulatory activities for product development and approval in alignment with the corporate strategy for Viridian's Thyroid Eye Disease (TED) and TSHR portfolio. Communicate with internal and external stakeholders, including members of the leadership teams, to ensure cross-functional alignment, work with Regulatory CMC and Regulatory Operations teams to establish and meet timelines for regulatory submissions.
BioNTech SEAssociate Director, Global Regulatory Affairs - Ad / Promo BioNTech SEAssociate Director, Global Regulatory Affairs - Ad / PromoCambridge, MAThis position requires frequent interaction and strong collaboration with Commercial, Medical Affairs, Legal, Global Regulatory Affairs, Labeling and Compliance for the purpose of providing regulatory advice and guidance during promotional plan development all the way through to field implementation assuring conformity with FDA requirements, PhRMA DTC Guidelines and BioNTech policies. Provides input into labeling strategies for investigational and marketed products impacting potential US product promotion and is responsible for leading interactions with the FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotion Labeling Branch (APLB) pertinent to assigned brand(s).
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.
Merck & Co IncExecutive Director, Regulatory Affairs Liaison Merck & Co IncExecutive Director, Regulatory Affairs LiaisonBoston, MA$231,900–$365,000 / yearRequired Skills: Accountability, Accountability, Business Development, Communication, Complaint Management, Cross-Cultural Awareness, External Communication, Global Health, Global Regulatory, Leadership, Oncology Drug Development, Ophthalmology, People Management, Pharmaceutical Regulatory Affairs, Professional Integrity, Project Resource Allocation, Project Tasks, R&D Strategy, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Compliance, Regulatory Experience, Regulatory Filings, Regulatory Strategy Development, Resource Allocation {+ 3 more}. Provide oversight for direct reports and support them to function as the single global point of accountability for assigned projects, partnering closely with international regulatory colleagues and engaging global health authorities to deliver on Company priorities.
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.
Merck & Co IncExecutive Director, Regulatory Affairs Merck & Co IncExecutive Director, Regulatory AffairsBoston, MA$255,800–$402,700 / year10% Travel Required Skills: Antibody Drug Conjugates (ADC), Antibody Drug Conjugates (ADC), Biopharmaceuticals, Biopharmaceutics, Chemistry, Collaborative Development, Confidentiality, Cross-Cultural Awareness, Decision Making, Electronic Common Technical Document (eCTD), Executive Management, Mentoring Staff, People Leadership, Pharmaceutical Sciences, Professional Networking, Project Management, Regulatory Affairs Management, Regulatory CMC, Regulatory Compliance Audits, Regulatory Development, Regulatory Monitoring, Regulatory Reporting, Regulatory Risk, Regulatory Submissions, Risk Analysis {+ 2 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Accountable for ensuring successful development and implementation of the global CMC regulatory strategy and for global registration and post approval strategy for new products to meet our company's business needs Leads the team responsible regulatory CMC deliverables including submissions supporting clinical studies through initial market applications and post-approval to ensure global commercial supply.
Alnylam Pharmaceuticals IncNewAssociate Director Regulatory Affairs CMC Alnylam Pharmaceuticals IncAssociate Director Regulatory Affairs CMCMA$170,900–$231,300 / yearLead or help to lead the interpretation of regulatory expectations for emerging modalities, including oligonucleotide therapeutics, conjugated delivery systems (e.g., GalNAc and other targeting ligands), antibody-drug conjugates, peptide conjugates, and biologic or hybrid modalities. This role serves as a key bridge between Research, Pharmaceutical Development, Technical Operations, and Regulatory Sciences, helping to translate evolving science into effective global regulatory CMC strategies.
Blue Cross and Blue Shield of Massachusetts IncPolicy Manager, Government and Regulatory Affairs Blue Cross and Blue Shield of Massachusetts IncPolicy Manager, Government and Regulatory AffairsBoston, MA$102,330–$125,070 / yearAn employee's pay position within the salary range will be based on several factors including, but limited to, relevant education, qualifications, certifications, experience, skills, performance, shift, travel requirements, sales or revenue-based metrics, and business or organizational needs and affordability. Learn how we are dedicated to creating an inclusive and rewarding workplace that promotes excellence and provides opportunities for employees to forge their unique career path by visiting our Company Culture page.
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.
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.
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.
Rhythm Pharmaceuticals IncNewAssociate Director, Regulatory Affairs Rhythm Pharmaceuticals IncAssociate Director, Regulatory AffairsBoston, MA$160,000–$240,000 / yearFor 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.
Northeastern UniversityPostdoctoral Research Fellow-Ironwood Pharmaceuticals, Regulatory Affairs Northeastern UniversityPostdoctoral Research Fellow-Ironwood Pharmaceuticals, Regulatory AffairsBoston, MA$60,315–$85,192.50 / yearThe fellow will have the opportunity to work collaboratively with other functional areas within Ironwood, including global patient safety, clinical development, medical scientific affairs, program management, data sciences, quality and compliance, nonclinical, medical writing and publications, and chemistry, manufacturing, and controls, as well as experience partner interactions and engage in vendor oversight. Responsibilities: The purpose of the Regulatory Affairs (RA) Fellowship is to provide the fellow with training in the functional area and to prepare them to enter an industry role as an individual contributor in Global Regulatory Affairs after the end of their 2-year fellowship.
Rhythm PharmaceuticalsNewAssociate Director, Regulatory Affairs Rhythm PharmaceuticalsAssociate Director, Regulatory AffairsBoston, MA$160,000–$240,000 / yearFor 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.
Thermo Fisher Scientific IncDirector, Regulatory Affairs Thermo Fisher Scientific IncDirector, Regulatory AffairsMA$175,000–$219,000 / yearWe provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy.
Prestige ScientificNewDirector Regulatory Affairs Prestige ScientificDirector Regulatory AffairsBoston, MAWith real autonomy and visibility, you'll shape cross-functional decisions, influence clinical and CMC strategy, and help build regulatory infrastructure in a fast-growing biotech environment. If you bring deep small-molecule expertise and thrive where strategy meets execution, this is a chance to make a meaningful impact on a program with real momentum.
Azurity Pharmaceuticals - USNewDirector, 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.
Katalyst Healthcares & Life SciencesNewSenior Regulatory Affairs Manager Katalyst Healthcares & 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.
Butterfly NetworkNewSenior International Regulatory Affairs Specialist Butterfly NetworkSenior International Regulatory Affairs SpecialistBurlington, MAThis role requires a strong ability to translate evolving regulatory requirements—such as EU MDR 2017/745—into clear, actionable plans, while partnering cross-functionally to align regulatory expectations with fast-paced product and software development cycles. In addition to its medical imaging products, Butterfly Embedded is the Company's Ultrasound-on-Chip licensing and co-development program designed to enable a new wave of ultrasound-enabled technologies across non-competitive healthcare markets and beyond.
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 Dyne Therapeutics IncExecutive Director, Regulatory AffairsWaltham, MA$250,000–$310,000 / yearRole Summary: The Executive Director, Regulatory Affairs serves as a visionary leader who shapes long-term program regulatory strategy, collaborates on regulatory functional strategy, and drives organizational impact across Dyne''s regulatory operations. This position requires a leader who contributes to department-wide strategy, develops corporate policies and processes that influence the organization''s direction, and ensures alignment with the mission of delivering meaningful outcomes for patients.
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.
Stoke Therapeutics IncDirector, Global Regulatory Affairs Stoke Therapeutics IncDirector, 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.
Kura OncologyNewDirector, Regulatory Affairs Kura OncologyDirector, Regulatory AffairsBoston, MA$226,495–$258,817 / yearKura developed and is commercializing KOMZIFTI (ziftomenib), the FDA-approved once-daily, oral menin inhibitor for the treatment of adults with relapsed or refractory NPM1-mutated acute myeloid leukemia, and continues to pioneer advancements in menin inhibition and farnesyl transferase inhibition. Kura Oncology is a commercial-stage biopharmaceutical company committed to discovering and developing innovative precision medicines to help patients with cancer lead better, longer lives.
Carrier CorporationRegulatory Affairs & Compliance Lead Carrier CorporationRegulatory Affairs & Compliance LeadBeverly, MA$96,000–$192,000 / yearIn this strategic individual contributor role, the Regulatory Affairs & Compliance Lead collaborates cross-functionally with Product Development, Quality, Manufacturing, Marketing, Legal, and Compliance teams to ensure regulatory alignment and market readiness. The Regulatory Affairs & Compliance Lead leads the development and execution of global regulatory strategies, manage submissions and regulatory changes, and support product launches across international markets.
Takeda Pharmaceutical Co LtdDirector, Global Regulatory Affairs CMC Takeda Pharmaceutical Co LtdDirector, 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.
Sanofi GroupNewDirector, US Regulatory Affairs - Advertising and Promotion Sanofi GroupDirector, US Regulatory Affairs - Advertising and PromotionCambridge, MA$178,500–$257,833.33 / yearAbout You** + Earned Bachelor’s degree (required) from an accredited four-year college or university in a Life Sciences or other relevant discipline + 8+ years of experience within pharmaceutical or medical device Regulatory Affairs, with 5+ years specifically within advertising & promotion functions + Leadership, mentoring and/or training experience within regulatory or ad/promo is highly preferred + Extensive knowledge and understanding of complex medical and scientific subject matter, including statistical data. Director/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.
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.
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.
HP HoodNewRegulatory Affairs Specialist HP HoodRegulatory Affairs SpecialistWilmington, MA$76,000–$90,000 / yearDocument maintenance & communication for support of claims, product and packaging regulatory compliance, customer requests utilizing Hood systems, posting and monitoring portal content, and providing support to operations and food safety & quality for document requests during third party and customer audits. Shared responsibilities include: technical label review and approval, updates/maintenance of systems housing product nutrition and finished product assets, and customer requests for technical information and regulatory documents.
Monte Rosa TherapeuticsNewManager, Regulatory Affairs Monte Rosa TherapeuticsManager, Regulatory AffairsBoston, MAResearches 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.
Dentsply Sirona IncRegulatory Affairs Specialist Dentsply Sirona IncRegulatory Affairs SpecialistWaltham, MADentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. Key Responsibilities: Prepares and submits international regulatory submissions to obtain and maintain regulatory approvals for medical devices, including 510(k) submissions and technical files for CE Marking.
Clinical DynamixNewVice President Regulatory Affairs Clinical DynamixVice President Regulatory AffairsCambridge, MARegulatory Affairs recommends development phase-appropriate strategies and tasks to guide development in compliance with regulation and regulatory guidance to maximize efficient and successfully leading to regulatory approval for the company's off-the-shelf stem cell technology. The Vice President of Regulatory Affairs will be a member of the Leadership Team and work closely with the various members of Executive Leadership, Program Management, Technical Operations, and Nonclinical Development.
Dentsply Sirona IncSenior Regulatory Affairs Specialist Dentsply Sirona IncSenior Regulatory Affairs SpecialistWaltham, MAFor California Residents: We may collect the following categories of personal information in connection with the submission of your resume or application materials to us for employment, and if hired, your employment with us: identifiers (e.g., name, address, email address, birthdate); personal records (e.g., telephone number, signature, education information, criminal background information, passport number and visa information); consumer characteristics (e.g., sex, marital status, veteran status, race, disability, sexual orientation); professional or employment information (e.g., resume, cover letter, employment history, background check forms, references, certifications, transcripts and languages spoken); and inferences from personal information collected (e.g., a profile reflecting abilities and aptitudes). The above categories of personal information are collected for the following business purposes: performing recruitment and hiring services; processing interactions and transactions (e.g., to comply with federal and state laws requiring us to maintain certain records, managing the workforce); and security (e.g., detecting security incidents, protecting against fraudulent or illegal activity).
Medtronic PlcPrincipal Regulatory Affairs Specialist Medtronic PlcPrincipal Regulatory Affairs SpecialistDanvers, MAThis role is responsible for shaping and executing global regulatory strategies, with a strong focus on pre-market submissions and early engagement with the global regulatory partners and/or regulatory authorities, as appropriate, across the United States, European Union, China, Japan, and Australia. Strategic direction is expected to support a number of regulatory applications which may include, FDA Pre-submissions, PMDA consultations, original IDEs and PMAs, IDE and PMA Supplements/Reports, Shonin applications, China PTR submissions, and EU MDR Technical Documentation.
Parexel International CorpRegulatory Affairs Talent Pool (US & Canada) Parexel International CorpRegulatory Affairs Talent Pool (US & Canada)MARegulatory Affairs is a diverse and dynamic field, offering pathways for specialists across multiple disciplines: • Labeling Operations - ensuring accuracy and compliance in product information. Our Regulatory Affairs opportunities offer the ability to work remotely from home, empowering you to contribute globally while maintaining balance in your personal and professional life.
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.
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.
Hemab TherapeuticsNewDirector, Regulatory Affairs Hemab TherapeuticsDirector, Regulatory AffairsCambridge, MAYou will be responsible for developing and executing innovative global regulatory strategies for the global development of candidates. Director, Regulatory Affairs.
Beam TherapeuticsNewManager/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.