Document Control/Regulatory Compliance Coordinator - M PLS Staffing Solutions, IncDocument Control/Regulatory Compliance Coordinator - MBeverly, MA$60,000–$65,000 / yearFull timeResponsible for creation, organization, control, and maintenance of various core processes documentation (Engineering, Quality, and other Operations) in accordance with the company Quality Management System (QMS) procedures and policies. Regulatory Compliance will support the organization's Regulatory Affairs and Quality Assurance functions in multiple areas including documentation, compliance, audits and regulatory submissions.
Senior Director Regulatory Affairs Liaison- General Medicine Merck & Co IncSenior Director Regulatory Affairs Liaison- General MedicineBoston, MA$190,800–$300,300 / yearRequired Skills: Corporate Commercial, Cross-Cultural Awareness, Drug Development, Exercises Judgment, Global Health, Global Market, Healthcare Innovation, Interpersonal Relationships, In Vitro Diagnostics (IVD), Multiple Therapeutic Areas, Oral Communications, Orphan Drugs, Pharmaceutical Regulatory Affairs, Process Improvements, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Issues, Regulatory Management, Regulatory Strategy Development, Written Communication. As the Global Regulatory Lead (GRL), the Senior Principal Scientist functions as the regulatory single, accountable, global point of contact on the project team and interacts with the global regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more company investigational and marketed drugs/biologics in early- and/or late-stage development.
Director, Regulatory Affairs Liaison, Vaccines & Infectious Diseases Merck & Co IncDirector, Regulatory Affairs Liaison, Vaccines & Infectious DiseasesBoston, MA$210,400–$331,100 / yearRequired Skills: Biological Sciences, Biostatistics, Clinical Judgment, Clinical Trial Planning, Clinical Trials, Communication, Cross-Functional Collaboration, Detail-Oriented, Infectious Disease, Leadership, Medical Writing, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Intelligence, Regulatory Issues, Regulatory Strategy Development, Regulatory Writing. Primary activities include, but are not limited to: Functions with a high degree of independence and provides regulatory oversight for assigned products, functioning as the single, accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.
Director, Regulatory Affairs – Global Regulatory Strategy Monte Rosa Therapeutics, IncDirector, Regulatory Affairs – Global Regulatory StrategyBoston, MassachusettsFull timeOverview: 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.
Vice President, Regulatory Affairs Rhythm Pharmaceuticals IncVice President, Regulatory AffairsBoston, MA$260,000–$360,000 / yearThis leader will oversee a geographically diverse team responsible for execution of international regulatory affairs, regulatory operations, regulatory business operations, labeling, and CMC regulatory, while partnering closely with global regulatory strategy and cross-functional teams. Proven operational leadership with urgency and discipline, including experience leading high-performing teams, team leaders, and subject matter experts through growth, change, and increasing organizational complexity.
Regulatory Affairs Strategy Director AstraZeneca PlcRegulatory Affairs Strategy DirectorBoston, MA$186,232.80–$279,349.20 / yearCompetitive salary and benefits package on offer: Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. The more experienced you are, the more accountability you will have for strategic leadership including responsibility for development and implementation of the global regulatory strategy for a product/group of products of increasing complexity.
NewChief of Staff, Senior Director Global Regulatory Affairs AstraZeneca PlcChief of Staff, Senior Director Global Regulatory AffairsBoston, MA$218,058.40–$327,087 / yearOrganizational Effectiveness and Change: Support organization design, capability building, and talent initiatives; lead change programs and improvements in ways of working that increase clarity, speed, and accountability across the regulatory organization. Cross-Functional and Enterprise Coordination: Partner across R&D, Commercial, Safety, Medical, Legal, Finance, and Procurement to align competing priorities; coordinate across programs, therapy areas, and regions to resolve complex issues that impact filing readiness and approvals.
Associate 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.
Regulatory Affairs Manager Dentsply SironaRegulatory Affairs ManagerBoston, MAThis role works closely with business partners for registrations in their respective countries to ensure compliance globally and acts as an internal champion for initiatives aimed at improving business systems and compliance. • Manages day-to-day activities for less senior Regulatory Affairs professionals, including but not limited to mentoring, coaching, performance reviews, developmental plans, and succession planning.
Regulatory Affairs Specialist CareerscapeRegulatory Affairs SpecialistBoston, MA$90,000–$125,000 / yearFull timeOur client, a clinical-stage biotechnology company based in Boston's Seaport District, is looking for a Regulatory Affairs Specialist to join their growing regulatory team. The position reports directly to the VP of Regulatory Affairs and works closely with cross-functional teams including R&D, clinical operations, and quality assurance.
Director, 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.
Vice President, Regulatory Affairs Rhythm PharmaceuticalsVice President, Regulatory AffairsBoston, MAFull timeThis leader will oversee a geographically diverse team responsible for execution of international regulatory affairs, regulatory operations, regulatory business operations, labeling, and CMC regulatory, while partnering closely with global regulatory strategy and cross-functional teams. Proven operational leadership with urgency and discipline, including experience leading high-performing teams, team leaders, and subject matter experts through growth, change, and increasing organizational complexity.
Senior Director, Regulatory Affairs Strategy - Cell and Gene Therapy AstraZeneca PlcSenior Director, Regulatory Affairs Strategy - Cell and Gene TherapyBoston, MA$218,058–$327,087 / yearAccountabilities: Global Regulatory Leadership: Own the end-to-end global regulatory strategy for a high-complexity cell and gene therapy program, from current stage through BLA submission, ensuring an efficient route to approval with competitive labeling aligned to product attributes and patient, market and business needs. Cross-Functional Product Leadership: Represent Regulatory Affairs on Global Product Teams, shaping development and commercialization plans, contributing to governance presentations and aligning regulatory objectives with clinical, CMC, safety and commercial strategies.
Senior Director, Regulatory Affairs Bicara TherapeuticsSenior Director, Regulatory AffairsBoston, MassachusettsFICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF--driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients. Founded in 2020, we've built a global team of over 100 employees headquartered in Boston, with a clear focus on advancing our lead asset, ficerafusp alfa, or FICERA - a potentially first-in-class bifunctional EGFR-directed antibody combined with a TGF- ligand trap.
Director, Regulatory Affairs - Clinical Strategy Azurity Pharmaceuticals IncDirector, Regulatory Affairs - Clinical StrategyWoburn, MABrief Team/Department Description: 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. Principle Responsibilities: • Development 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.
Manager, Regulatory Affairs Monte Rosa Therapeutics, IncManager, Regulatory AffairsBoston, MassachusettsFull timeResearches 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.
Sr. Specialist, Regulatory Affairs LeMaitreSr. Specialist, Regulatory AffairsBurlington, Massachusetts$110,000–$150,000 / yearFull timeProvide support to currently marketed products including: reviewing of engineering change orders, labeling, promotional material, product changes and documentation for changes requiring regulatory approval. Candidate will prepare regulatory submissions for new products/product changes to ensure timely approval for market release and will follow up with regulatory agencies on these submissions.
Director, Business Development Regulatory Affairs Olympus CorpDirector, Business Development Regulatory AffairsWestborough, MATake responsibility for all RA aspects of each business development project by a) conducting or overseeing due diligence and integration activities, b) building a functional plan for each project to ensure that functional risks are identified, and actions are planned, and c) securing necessary approvals from RA/regional leadership for due diligence reports and integration strategy/plans. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America.
NewAssociate Director, Regulatory Affairs CMC Skyhawk Therapeutics IncAssociate Director, Regulatory Affairs CMCWaltham, MA$170,000–$230,000 / yearWorking closely with the Director, RegCMC, you will help serve as a RegCMC point of contact across the organization, partnering with Pharmaceutical Development, Manufacturing, Quality, and Program teams to deliver high-quality, timely regulatory submissions that advance clinical development and support eventual commercialization. We use our novel SkySTAR platform (Skyhawk Small molecule Therapeutics for Alternative splicing of RNA) to develop drug candidates directed toward targets for some of the world's most intractable diseases including neurological conditions, cancer, and traditionally "undruggable" targets.
Head of Regulatory Affairs North America Fresenius Medical CareHead of Regulatory Affairs North AmericaWaltham, MassachusettsWorking knowledge of the U.S. Food Drug and Cosmetic Act, and all associated regulations, especially the FDA medical device product approval processes, FDA legislature/regulation, post market approval requirements, and Quality Systems Regulations. Ensures all employees within the assigned team(s) understand and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations; establishing and maintaining effective internal systems and controls to promote compliance.
Senior Regulatory Affairs Specialist Smith & Nephew PlcSenior Regulatory Affairs SpecialistMansfield, MA$101,500–$152,250 / yearThe anticipated base compensation range for this position is $101,500.00 - $152,250.00 USD annually and the compensation offered will depend on the candidate's qualifications, job-related knowledge/skills, geographical location. Inclusion and Belonging- Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website ( https://www.smith-nephew.com/
Regulatory 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.
Sr. Manager Regulatory Affairs CMC Alnylam Pharmaceuticals IncSr. Manager Regulatory Affairs CMCCambridge, MA$144,400–$195,400 / yearHelps to lead the interpretation of regulatory expectations for emerging modalities, including: siRNA and oligonucleotide therapeutics Conjugated delivery systems (e.g., GalNAc and other targeting ligands including biologic modalities) Complex drug substance and drug product configurations Helps to assess CMC implications of new technologies and modalities, including: Impact on product characterization, control strategies, and specifications Regulatory classification considerations (e.g., small-molecule vs biologic paradigms) Manages regulatory compliance activities including periodic regulatory reporting, review of technical documents, and providing regulatory assessments. Broad understanding of: Drug substance and drug product development Analytical characterization and control strategies Regulatory framework across major regions (e.g., US, EU, Japan, China) Strong ability to integrate scientific, technical, and regulatory considerations into clear strategies #LI-KB1 #LI-Hybrid U.S. Pay Range $144,400.00 - $195,400.00 The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting.
Associate 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.
Executive Director, Regulatory Affairs Merck & Co IncExecutive Director, Regulatory AffairsMA$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.
Senior Manager, Regulatory Affairs Kymera TherapeuticsSenior Manager, Regulatory AffairsWatertown, MA$145,000–$215,000 / yearHaving advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Reporting to the Director of Regulatory Affairs, the Senior Manager will independently lead regulatory activities at the study level, acting as the regulatory representative on cross-functional teams while driving execution of program regulatory strategies.
Associate Director, Regulatory Affairs CMC Voyager TherapeuticsAssociate Director, Regulatory Affairs CMCCambridge, MassachusettsThe Associate Director of Regulatory Affairs CMC will be responsible for developing, implementing and advising on global Regulatory CMC strategies for new and late stage programs to secure approval of the manufacturing process and control testing for initial clinical trials under INDs/CTAs and transition to appropriate GMP validation to move expeditiously in Phase 3 trials with material suitable for commercialization to support market access for Voyager’s gene therapy products. The qualified candidate will define Regulatory CMC submission strategies and plan, construct, direct, write summaries/reports for CMC sections of INDs, CTAs, BLAs and MAAs including post-approval supplemental applications and coordinate responses during the review/approval by Regulatory authorities.
Head of Regulatory Affairs Pulpdent CorpHead of Regulatory AffairsMAPulpdent is third-generation family-owned business that is widely respected for its innovative products and authentic company culture, which promotes work-life balance, employee retention, and product excellence. The Head of Regulatory Affairs will lead and evolve Pulpdent's global regulatory strategy across the full product lifecycle-from R&D and commercialization to quality assurance and post-market surveillance.
Senior Manager, Regulatory Affairs NAM Straumann Holding AGSenior Manager, Regulatory Affairs NAMMAThis role leads the planning, preparation, and submission of regulatory filings (e.g., Pre-Submissions, 510(k)s, PMAs, PMA Annual Reports, IDEs, and License Applications) and serves as a key regulatory partner to cross-functional teams. This role collaborates closely with global regulatory counterparts within the Straumann Group (e.g., Medentika, Neodent, Anthogyr, Dental Wings, etc.) and manages/develops regulatory staff and/or leads complex regulatory projects.
NewChief of Staff, Senior Director Global Regulatory Affairs AlexionChief of Staff, Senior Director Global Regulatory AffairsBoston, MassachusettsOrganizational Effectiveness and Change: Support organization design, capability building, and talent initiatives; lead change programs and improvements in ways of working that increase clarity, speed, and accountability across the regulatory organization. Cross-Functional and Enterprise Coordination: Partner across R&D, Commercial, Safety, Medical, Legal, Finance, and Procurement to align competing priorities; coordinate across programs, therapy areas, and regions to resolve complex issues that impact filing readiness and approvals.
Postdoctoral 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.
NewChief of Staff, Senior Director Global Regulatory Affairs Alexion Pharmaceuticals IncChief of Staff, Senior Director Global Regulatory AffairsBoston, MA$218,058.40–$327,087 / yearOrganizational Effectiveness and Change: Support organization design, capability building, and talent initiatives; lead change programs and improvements in ways of working that increase clarity, speed, and accountability across the regulatory organization. Cross-Functional and Enterprise Coordination: Partner across R&D, Commercial, Safety, Medical, Legal, Finance, and Procurement to align competing priorities; coordinate across programs, therapy areas, and regions to resolve complex issues that impact filing readiness and approvals.
Sr Regulatory Affairs Spec Medtronic PlcSr Regulatory Affairs SpecBoston, MAThis role will partner closely with Geography Regulatory Affairs to support international submissions, government queries, registration documentation, product approval and clearance activities, product demand and release planning, and post-market regulatory compliance to help ensure continued product availability worldwide. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
Manager, Regulatory Affairs Advertising & Promotion (Work from Home) ParexelManager, Regulatory Affairs Advertising & Promotion (Work from Home)MassachusettsThis individual will act as a trusted advisor, collaborating across cross-functional teams within a large, dedicated client partnership—helping to influence regulatory strategy and deliver meaningful impact, all while working remotely. This role extends beyond execution, requiring a proactive leader who can independently review materials, interpret evolving FDA guidance, and pivot regulatory strategy to support business objectives while mitigating risk.
Strategy Lead, CMC Mature, Regulatory Affairs GSK plcStrategy Lead, CMC Mature, Regulatory AffairsWaltham, MA$113,850–$189,750 / yearGSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment.
Senior International Regulatory Affairs Specialist Butterfly Network IncSenior 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.
NewExecutive Director, Regulatory Affairs Beeline MedicinesExecutive Director, Regulatory AffairsBoston, MassachusettsLed by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully. As a seasoned professional in Regulatory Affairs, develop Global Regulatory strategies and serve as the Global Regulatory Leader (GRL) for assigned Regulatory Project Teams to form global strategies and serve as the US Regulatory Lead (USRL) in the development of US regulatory approaches and execution of US filings.
Executive Director, Global Regulatory Affairs CMC Early Development Takeda Pharmaceutical Co LtdExecutive Director, Global Regulatory Affairs CMC Early DevelopmentBoston, MA$238,000–$374,000 / yearAccountable for ensuring global CMC content quality and compliance for early development submissions and lifecycle changes through Phase 2 (e.g., IND/CTA modules, IMPD quality sections, amendments, investigator's brochure CMC, and responses to health authority questions), partnering with regional leads and technical functions to ensure consistent, inspection-ready documentation. Represents Global Regulatory Affairs CMC in senior-level governance and in interactions with global health authorities, including FDA, EMA, MHRA, PMDA, and other agencies as applicable, to enable efficient pathways for early development CMC strategies and submissions (e.g., pre-IND/IND/CTA, amendments, Type B/C meetings, scientific advice).
Senior Manager Regulatory Affairs Chemistry Manufacturing and Controls CMC AbbVie IncSenior Manager Regulatory Affairs Chemistry Manufacturing and Controls CMCWaltham, MARepresents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions. The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients to deliver biologics products to patients, including mAb, ADC and cell & gene therapies.
Director, Global Regulatory Affairs Process Excellence and Transformation Vertex Pharmaceuticals IncDirector, Global Regulatory Affairs Process Excellence and TransformationBoston, MA$196,800–$295,200 / yearAs a key member of the GRA Process Optimization Network (GPON), this role consults with cross-team representatives to diagnose operational challenges and deliver scalable, sustainable solutions. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.
NewExecutive Advisor, Enterprise Risk and Regulatory Affairs University of Massachusetts Medical SchoolExecutive Advisor, Enterprise Risk and Regulatory AffairsWestborough, MassachusettsThe incumbent will work closely with For Health Consulting Deputy Executive Vice Chancellor, Associate Executive Vice Chancellors (AEVCs) and Managing Directors (MDs) to anticipate and address potential legal risks related to new and existing For Health business initiatives and internal processes; serve as a creative problem solver for complex business, legal, and compliance challenges to facilitate the development of business strategy and subsequent growth in products and services; and lead negotiations on behalf of ForHealth Consulting where appropriate. In this leadership position, the candidate must demonstrate influencing skills and organizational savvy to effectively interact with multiple internal business unit leaders at ForHealth Consulting, key stakeholders throughout the broader UMass Chan Medical School and University of Massachusetts system, and many other external partners in public and private organizations.
Regulatory Affairs Associate:$71,449+ YR Ajinomoto Cambrooke, Inc.Regulatory Affairs Associate:$71,449+ YRAyer, MAAbility to sit for extended periods, perform visual inspections of labels/documents, occasional lifting up to 25 lbs., standing/walking/bending as needed. Perform regulatory research, document reviews, label proofreading, version control, and cross-functional coordination to enable compliant product release.
Senior International Regulatory Affairs Specialist Butterfly NetworkSenior International Regulatory Affairs SpecialistBurlington, MAIn 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. Utilize and maintain regulatory systems and tools (e.g., document management systems, regulatory submission platforms, and tracking tools) to support ongoing regulatory activities, submissions, and communications with regulatory bodies.
Staff Regulatory Affairs Associate (Digital Health & AI Technologies) Whoop IncStaff Regulatory Affairs Associate (Digital Health & AI Technologies)Boston, MA$170,000–$220,000 / 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. Partner with Product, Engineering, and AI/ML teams to evaluate regulatory implications of new features, algorithms, health insights, claims, intended uses, and user experiences, and recommend appropriate regulatory and claims strategies.
Executive Director, Regulatory Affairs AVEO Pharmaceuticals IncExecutive Director, Regulatory AffairsBoston, MAExecutive Director, Regulatory Affairs - Boston, MA Skip To Content. Skip to content Main Navigation.
NewDirector, Regulatory Affairs Strategy - Cell Therapy AstraZeneca PlcDirector, Regulatory Affairs Strategy - Cell TherapyBoston, MA$186,232–$279,349 / yearPartnering with senior leaders and global teams, you will lead strategy across key milestones-from expedited designations and Health Authority interactions through major submissions and post-approval maintenance-helping the business deliver transformative therapies at pace and with rigor. In this Director role, you will shape the regulatory path for programs that span oncology, immune-mediated and rare diseases-translating breakthrough science into timely approvals and competitive labeling that make a tangible difference to patients and markets.
Associate Director Regulatory Affairs Alnylam Pharmaceuticals IncAssociate Director Regulatory AffairsCambridge, MA$170,900–$231,300 / yearAdditional responsibilities include involvement in the writing and oversight of regulatory submissions, coordinating all aspects of paper and electronic regulatory submissions, proactively keeping updated on US regulatory requirements, and interpreting regulatory intelligence for the internal teams. Serve as member of/or lead the Global Regulatory Team, may serve as Regulatory representative in multidisciplinary product subteams or core team for assigned programs and participate as an active team member.
VP or SVP, Regulatory Affairs Acrivon Therapeutics IncVP or SVP, Regulatory AffairsWatertown, MAThese distinctive capabilities enable the company to go beyond the limitations of traditional drug discovery, as well as current AI-based target-centric drug discovery and rapidly design highly differentiated compounds with desirable pathway effects through intracellular protein network analyses and advance these agents into the clinic for streamlined development. Acrivon is currently advancing its lead program, ACR-368 (also known as prexasertib), a selective small molecule inhibitor targeting CHK1 and CHK2 in a potentially registrational Phase 2 trial for endometrial cancer.
Senior Regulatory Affairs Specialist PhilipsSenior Regulatory Affairs SpecialistMA$99,000–$157,000 / yearThe actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. • Lead global regulatory intelligence initiatives, contribute to regulatory and product registration strategies, and help implement global regulatory roadmaps based on the competitive landscape and marketing objectives.