Senior Director, Regulatory Affairs CMC – Small Molecule Beeline MedicinesSenior Director, Regulatory Affairs CMC – Small MoleculeBoston, Massachusetts$242,000–$313,500 / yearAct as a fully integrated partner within the CMC team, attending key technical meetings, engaging daily with Process Development, Analytical, Manufacturing Sciences, Drug Supply and Quality colleagues, and translating regulatory strategy into practical guidance that enables the CMC team to make informed decisions and move programs forward with regulatory confidence. Demonstrate entrepreneurial drive and resourcefulness in executing CMC regulatory responsibilities — proactively seek out information, build relationships across the CMC organization, and find creative avenues to get things done; a successful CMC regulatory lead takes ownership of being plugged in, earns trust within the team, and removes barriers through initiative and ownership.
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.
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.
Associate Director, Global Regulatory Affairs, Precision Medicine & Digital Health 3316 Takeda Development Center AmericasAssociate Director, Global Regulatory Affairs, Precision Medicine & Digital HealthMassachusettsRemotePartner with local/regional regulatory representatives to lead and support lifecycle management regulatory activities for the digital health and precision medicine portfolio, including change impact assessments, regulatory strategy alignment, and execution of required maintenance submissions/notifications to ensure ongoing compliance across markets. Provides strategic and tactical guidance to teams for the delivery of global regulatory strategies to support development and commercialization of biomarkers, diagnostic tests, devices and digital health tools to enhance the value of our products across therapeutic areas and to ensure goals/objectives are met.
Senior Regulatory Affairs Specialist - Software OrganOxSenior Regulatory Affairs Specialist - SoftwareBoston, MA$115,000–$140,000 / yearUnder direction from the Director, Regulatory Affairs, Software and Innovation, the Senior Regulatory Affairs Specialist will be responsible for: · Providing regulatory affairs support for projects related to Digital Health, Software, Cybersecurity, Electromechanical devices and Regulatory Intelligence. Founded in 1921, Terumo Corporation strives to fulfill its mission of “Contributing to Society through Healthcare” by providing a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions.
Senior Director, Regulatory Affairs (Ad Promo) Bausch Health Companies IncSenior Director, Regulatory Affairs (Ad Promo)Boston, MA$215,000–$296,000 / yearRepresents regulatory affairs in cross functional prescription product promotional review teams as required, participate in development committees for processes and procedures relating to ad promo. Job Location: Washington, District of Columbia, USA | Boston, Massachusetts, USA | Bridgewater, New Jersey, USA | NewYorkCity, New York, USA | Philadelphia, Pennsylvania, USA.
Senior Manager, Regulatory Affairs, Advertising and Promotion Les Laboratoires Servier SASSenior Manager, Regulatory Affairs, Advertising and PromotionBoston, MA$150,000–$170,000 / yearThe Senior Manager, Regulatory Affairs Advertising and Promotion at Servier Pharmaceuticals will report to the Director of US Regulatory Affairs and Quality Management and is responsible for leading the day-to-day regulatory review of advertising, promotional, and educational materials. As a privately held organization, Servier is uniquely positioned to advance cutting-edge science, tackle underserved therapeutic areas and make patients the focus of every strategic decision.
Executive Advisor, Enterprise Risk and Regulatory Affairs UMass Chan Medical SchoolExecutive Advisor, Enterprise Risk and Regulatory AffairsWestborough, MAThe incumbent will work closely with ForHealth 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 ForHealth 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.
Executive Advisor, Enterprise Risk and Regulatory Affairs (2026-50295) University of MassachusettsExecutive Advisor, Enterprise Risk and Regulatory Affairs (2026-50295)Worcester, MARemoteThe incumbent will work closely with ForHealth 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 ForHealth 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. All Academic Accounting & Finance Administrative Professional Administrative Support Advancement Basic Science Biotechnology Clinical Research Environmental Health & Safety Executive Faculty Healthcare Human Resources Information Technology Interns Library Maintenance and Facilities Management Nursing Office Assistant Other Post Doc Professional Technician I Public Safety Research Residents Retail & Dining Services Staff Assistant Staff Associate Volunteer.
Associate Director, Regulatory Affairs - Advertising/Promotion (REMOTE) MannKind CorpAssociate Director, Regulatory Affairs - Advertising/Promotion (REMOTE)Boston, MARemoteAdditional key job duties and responsibilities are as detailed below and will include: Providing strategic advice on advertising and promotional activities for assigned products in accordance with business goals and objectives, Maintaining current knowledge and understanding of FDA regulations/guidelines PhRMA guidelines and company policy and sharing new developments with impacted team members, Informs teams for assigned products and projects on implementation of compliant product labeling and communications. Job Summary: The Associate Director, Regulatory Affairs will be responsible for coordinating and completing regulatory review and approval of all commercial materials, representing the Regulatory team on both the Medical Review Committee (MRC) and Promotional Review Committee (PRC), and leading interactions with the FDA Office of Prescription Drug Promotion (OPDP) for respective products.
Associate Director, Global Regulatory Affairs Kailera TherapeuticsAssociate Director, Global Regulatory AffairsWaltham, Massachusetts$155,000–$190,000 / yearThe Associate Director, Global Regulatory Affairs will be responsible for day-to-day regulatory activities of early/late phase investigational products, leading the writing and submission of IND/CTA/amendments and future marketing application submissions, providing guidance to the team on regulatory filings and responses, and providing critical regulatory intelligence and guidance back to the team. The Associate Director will work on cross-functional teams, partnering with key internal/external team members including Regulatory CMC and Regulatory Operations to ensure the scientific data and submissions fulfills agency expectations in a compliant manner.
Manager, Regulatory Affairs Deciphera Pharmaceuticals IncManager, Regulatory AffairsWaltham, MA$116,000–$160,000 / yearROMVIMZA (vimseltinib) is a kinase inhibitor approved in the United States for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity, and in the European Union for adult patients with TGCT associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability. In addition to advancing multiple product candidates from Deciphera's platform in clinical studies, QINLOCK (ripretinib) is Deciphera's switch-control kinase inhibitor approved in many countries including the European Union and the United States for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.
Manager, Regulatory Affairs DecipheraManager, Regulatory AffairsWaltham, MA$116,000–$160,000 / yearROMVIMZA (vimseltinib) is a kinase inhibitor approved in the United States for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity, and in the European Union for adult patients with TGCT associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability. In addition to advancing multiple product candidates from Deciphera's platform in clinical studies, QINLOCK (ripretinib) is Deciphera's switch-control kinase inhibitor approved in many countries including the European Union and the United States for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.
Sr. Regulatory Affairs Specialist Glaukos CorpSr. Regulatory Affairs SpecialistBurlington, MAOur constant pursuit of game-changing technologies that disrupt legacy treatment paradigms is encapsulated in the Glaukos mantra "We'll Go First," which articulates our willingness to take chances, our determination to forge new ground, and our commitment to continuous improvement in all that we do. Founded in 1998, Glaukos Corporation is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.
Senior Director, Regulatory Affairs Bicara Therapeutics IncSenior Director, Regulatory AffairsBoston, MAFICERA 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.
USA - Associate Director Global Regulatory Affairs The Fountain Group LLCUSA - Associate Director Global Regulatory AffairsCambridge, MA$134.90–$139.55 / hourLead global regulatory labeling strategy and lifecycle management for plasma-derived therapies (PDT), including CCDS, USPI, and EU SmPC. Lead global labeling teams and cross-functional labeling projects, including preparation, review, approval, and maintenance of submission-ready labeling.
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.
Associate Director, Regulatory Affairs Operations Third Rock VenturesAssociate Director, Regulatory Affairs OperationsCambridge, MA$200,000–$240,000 / yearThis role will focus on regulatory submission planning, execution, and lifecycle management, working closely with Regulatory Affairs leadership and cross-functional teams to ensure high-quality, timely regulatory submissions. 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.
Consultant II, Regulatory Affairs Advertising and Promotion Syner-GConsultant II, Regulatory Affairs Advertising and PromotionBoston, MARemoteThe work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. The Consultant II serves as a key regulatory partner to Commercial, Medical, Legal, and Global Regulatory teams, enabling timely and compliant execution of brand strategy across product launch and lifecycle activities.
Senior Regulatory Affairs Specialist Hologic IncSenior Regulatory Affairs SpecialistCambridge, MA$40,000–$50,000 / yearTo deliver on that purpose, we need strong regulatory expertise that helps bring new products to market, keeps mature products compliant, and ensures our submissions, labeling, technical files, and product documentation meet global regulatory expectations. This role is ideal for a regulatory professional with strong knowledge of US, EU, and Canadian requirements who enjoys working cross-functionally with Regulatory Affairs, R&D, Clinical, Quality, Marketing, and international regulatory teams.