Senior Director, Regulatory Affairs Ardelyx, Inc.Senior Director, Regulatory AffairsWaltham, MA$259,000–$317,000 / yearPartner with Clinical Development to provide input in designing early stage and registration-enabling trials, advising on endpoints, patient populations, statistical analysis plans, and labeling implications. Qualifications: Bachelor's degree, advanced degree preferred, in life sciences, pharmacy, chemistry, or related field with 12+ years of regulatory affairs experience in the pharmaceutical, biotechnology or medical device industry, or equivalent experience.
Regulatory Affairs Expert - Remote YO AI LabsRegulatory Affairs Expert - RemoteBoston, MassachusettsRemoteThe role involves assessing clinical documents, ensuring compliance with regulatory guidelines, identifying inconsistencies, and providing clear, evidence-based feedback to improve AI-generated regulatory content. We are seeking an experienced Regulatory Affairs Specialist to support AI-driven healthcare projects by reviewing and evaluating regulatory documentation.
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.
Associate Director Regulatory Affairs – Vascular (on-site) AbbottAssociate Director Regulatory Affairs – Vascular (on-site)Westford, MassachusettsMaintains expert working knowledge of laws, regulations and enforcement decisions related to Quality Assurance (QA), manufacturing and Research & Development (R&D) issues that may impact company operations and decision making; communicates such knowledge to all internal stakeholders. As a manager, the function of an Associate Director, Regulatory Affairs is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation.
Manager, Regulatory Affairs Collegium PharmaceuticalManager, Regulatory AffairsStoughton, MA$132,219–$158,400 / yearManage labeling for approved and investigational products, including U.S. prescribing information, clinical trial labeling, and packaging components, while coordinating cross-functional reviews to ensure regulatory compliance, accuracy, and consistency throughout the product lifecycle. They will work in a highly cross-functional manner with internal stakeholders including Medical, Commercial, Legal and Compliance, and Technical Operations to file and maintain the applications for Collegium's marketed products and development programs in compliance with applicable regulations.
Senior 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.
Senior Regulatory Affairs Specialist Advanced Regenerative Manufacturing Institute IncSenior Regulatory Affairs SpecialistManchester, NHFull timeD. is preferredMinimum of 8 years of direct work experience in human medical product regulatory affairs; experience with clinical trials of drugs or biologics is preferredThorough knowledge of U.S. FDA medical product regulations, current industry practices, and experience with interpretation and application of said regulations and practicesAbility to influence colleagues, clients, and Institute members at all levels in the organizationExceptional written and verbal communication skillsProficient with Microsoft software productsAbility to multi-task, meet deadlines, and set prioritiesAbility to work independently and thrive in a fast-paced, rapidly changing environmentCollaborative attitude, sense of curiosity, and eagerness to impact positive changeCommitment to quality, scientific integrity, and company missionStrong analytical and proactive problem-solving skills with a strong attention to detailAbility to work independently and manage competing prioritiesBy applying, I understand that any offer of employment is contingent upon the successful completion of a background check, in accordance with applicable laws. Overview The Advanced Regenerative Manufacturing Institute (ARMl)IBioFabUSA is a Member-based non-profit, member-driven, public-private partnership with a mission to advance the bioeconomy and transform the future of human health.
NewDirector, Regulatory Affairs CMC Vertex PharmaceuticalsDirector, Regulatory Affairs CMCBoston, Massachusetts$190,400–$285,600 / yearThe Director, Chemistry Manufacturing Controls (CMC) leads a Regulatory CMC team responsible for developing and executing global regulatory strategies across multiple investigational and commercial products in the small molecule portfolio. This role provides strategic leadership for complex regulatory CMC activities, oversees Health Authority engagement, and ensures regulatory requirements are effectively integrated into development and commercialization plans.
Executive Director, Global Regulatory Affairs AVEO OncologyExecutive Director, Global 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.
Senior Director or VP of Regulatory Affairs Compass TherapeuticsSenior Director or VP of Regulatory AffairsBrighton, MA$220,000–$370,000 / yearCoordinate and lead meetings with regulatory agencies including preparation and development of meeting strategies, briefing book roundtables and packages, cross-functional preparation, regulatory notifications, regulatory document workflows, agency interactions, responses to agency questions, and follow-up commitments. Orchestrate and deliver successful IND and BLA filings, amendments, supplements, reports, meeting requests, briefing packages, and any regulatory submissions, ensuring high-quality, timely, consistent and coordinated submissions, that meet technical and regulatory requirements.
Regulatory Affairs Project Manager DEKA Research & DevelopmentRegulatory Affairs Project ManagerManchester, NHHow you will make a difference as a Regulatory Project Manager: Work in close association with customers and development teams to define and execute regulatory approval and clearance programs, including establishing regulatory requirements and leading the preparation and submission of 510(k)s, PMAs, IDEs, Technical Files, and other international dossiers. Expertise in current FDA processes including the eSTAR submission tool, establishment registration and listing, UDI, product labeling, and post-market reporting including MDR’s and Field Action Reporting.
Senior Manager, Regulatory Affairs, Operations Xenon PharmaceuticalsSenior Manager, Regulatory Affairs, OperationsNeedham, MassachusettsOur Phase 3 epilepsy program also includes a second FOS study, X-TOLE3, which would support regulatory submissions outside the U.S., and the X-ACKT study in primary generalized tonic-clonic seizures, which would support regulatory submissions for an additional epilepsy indication. Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions.
NewFranchise Lead (Director, Global Regulatory Affairs CMC) 3316 Takeda Development Center AmericasFranchise Lead (Director, Global Regulatory Affairs CMC)Boston, MassachusettsProactively 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, and technical/CMC line functions - as appropriate. Works effectively across a complex matrix environment in GRA with GRLs, CMC RA project leads and other GRA sub-functions (e.g., Growth & Emerging Markets, Strategy, Labelling, etc.) to ensure effective strategies are implemented and project execution is on target.
Sr. Director, Regulatory Affairs Third Rock VenturesSr. Director, Regulatory AffairsCambridge, MA$245,000–$300,000 / yearThis individual will serve as a key cross-functional leader and regulatory expert, partnering closely with Program Leadership & Management, Clinical Development, Clinical Pharmacology, Clinical Operations, Biostatistics, Pharmacovigilance, CMC, Nonclinical, Quality, and Executive Leadership to advance innovative therapeutics through development and key regulatory milestones. We specifically target pathogenic antibodies and their cellular sources with bespoke Fc biotherapeutics engineered to selectively and completely eliminate the root causes of autoimmune and allergic diseases, and to achieve deep, durable responses while preserving essential immunity.
Director, Regulatory Affairs CMC Madrigal PharmaceuticalsDirector, Regulatory Affairs CMCWaltham, MassachusettsThis role provides strategic, tactical and operational regulatory CMC leadership to support clinical trial applications, market registrations and post-approval submissions, along with managing the day-to-day regulatory CMC activities of assigned projects for development and/or commercial products. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process.
Manager Regulatory Affairs-CMC Integrated Resources, IncManager Regulatory Affairs-CMCLexington, MassachusettsContractorLocation: Lexington, MA Duration: 4+months (Possibility of extension) Business Function: R&D Department Name: Global Regulatory Affairs Primary Role: Under the general direction of the CMC Regulatory Affairs team, develop a Core Dossier for Module 2.3 and Module 3 CTD sections for a marketed product, and leverage the Core Dossier documents to support Marketing Authorization Applications for international regions. Minimum of 5 years of related experience within a pharmaceutical company, CRO or similar organization and with minimum of 2 years International/Global CMC regulatory experience in biologics/small molecule drug development and registration activities.
NewAssociate Director, Scientific Communications Lead, Solid Tumors, Global Medical Affairs Oncology 3312 Takeda Pharmaceuticals AmericaAssociate Director, Scientific Communications Lead, Solid Tumors, Global Medical Affairs OncologyCambridge, MassachusettsYou will develop and implement strategic publications and scientific communications plans in coordination with relevant cross-functional teams (including members of medical affairs, clinical development, and outcomes research; global, regional, or local); leads the publications planning team; manages the development of scientific publications for external audiences and scientific communications materials such as slide decks, NCCN or pathway submissions, animations, and digital amplification of data; manages vendors, freelancers, and available contractors, writers, and editors in the execution of publication and scientific communications tactics; and manages annual budget planning for each assigned program(s). This individual will work closely with the Scientific Communications Group Lead, Solid Tumors to optimize department resources and evaluate trends in medical publications, and lead and/or participate in the development and review of publications SOPs and Work Practices, where appropriate, to ensure delivery of high-quality medical publications in a timely and compliant manner across programs.
NewAssociate Medical Director Hematology, US OBU Medical Affairs 3310 Takeda Pharmaceuticals U.Associate Medical Director Hematology, US OBU Medical AffairsBoston, MassachusettsThe 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. This role involves monitoring regulatory developments, ensuring compliance, and preparing regulatory documents to support Takeda's mission of delivering transformative therapies to patients.
NewSenior Medical Manager, Hematology - US Medical Affairs BiogenSenior Medical Manager, Hematology - US Medical AffairsCambridge, MassachusettsCoordinate and liaise with other internal stakeholders (eg, Global Medical, Clinical Development, Medical Evidence Generation Clinical Operations, Pharmacovigilance, R&D) to ensure scientific content and communications developed by the US Medical team are aligned with the Global Scientific Platform (content including but not limited to field medical slide decks, advisory board material, congress materials, and medical training). Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
Director, Government Legislative Affairs BlueCross and BlueShield of MassachusettsDirector, Government Legislative AffairsBoston, MA$198,360–$242,440 / yearDirectly advocate for the Company's interests in legislative hearings, regulatory sessions, and one-on-one meetings with legislators, regulators, and staff on issues impacting health care and the insurance industry, including behavioral health and substance use disorder treatment, prescription drug pricing and transparency policy, provider payment policy, municipal health reform, and utilization management tools. In-depth demonstrated knowledge and understanding of the health care and health insurance industry, including specific issue-area expertise in public policy related to behavioral health, substance use disorder, prescription drug pricing and transparency policy, provider payment policy, municipal health reform, and utilization management tools.