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.
Executive Director, Regulatory Affairs Beeline MedicinesExecutive Director, Regulatory AffairsBoston, Massachusetts$281,000–$344,000 / yearLed 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.
Director, Business Development Regulatory Affairs Job Details | Olympus Corporation Of The Americas OlympusDirector, Business Development Regulatory Affairs Job Details | Olympus Corporation Of The AmericasWestborough, 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.
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.
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.
NewRegulatory & Medical Affairs Project Manager TalteamRegulatory & Medical Affairs Project ManagerBurlington, MAEnsure optimal management of major regulatory agency interactions for your assigned projects including preparation of briefing materials, co-ordination of rehearsals and minutes. This includes the management and coordination of the preparation of all regulatory documentation, and ensuring all submission deliverables are of high quality.
Vice President, Regulatory Affairs Rhythm PharmaceuticalsVice 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.
Director, Global Regulatory Affairs Stoke Therapeutics, Inc.Director, 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.
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 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.
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.
Senior Director, Regulatory Affairs CMC – Small Molecule Beeline MedicinesSenior Director, Regulatory Affairs CMC – Small MoleculeBoston, MassachusettsAct 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.
Principal Regulatory Affairs Consultant Syner-GPrincipal Regulatory Affairs ConsultantFramingham, MAAs a Senior General Strategy Consultant, you will play a pivotal role in guiding clients through the complex landscape of regulatory affairs, ensuring compliance and facilitating the successful development and approval of pharmaceutical products. Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing.
Senior Regulatory Affairs Specialist PhilipsSenior Regulatory Affairs SpecialistCambridge, MA$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.
Associate Director Advertising and Promotion, Global Regulatory Affairs BiogenAssociate Director Advertising and Promotion, Global Regulatory AffairsCambridge, MassachusettsThe role of the Associate Director requires the ability to provide regulatory strategic advice primarily for U.S. communications related to disease education, promotional materials and medical/scientific materials for healthcare providers, payors and patients in support of Biogen business objectives. 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.
Associate Director Advertising And Promotion, Global Regulatory Affairs Biogen IdecAssociate Director Advertising And Promotion, Global Regulatory AffairsCambridge, MA$152,000–$209,000 / yearThe role of the Associate Director requires the ability to provide regulatory strategic advice primarily for U.S. communications related to disease education, promotional materials and medical/scientific materials for healthcare providers, payors and patients in support of Biogen business objectives. 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.
Senior Director, Regulatory Affairs CMC – Biologics Beeline MedicinesSenior Director, Regulatory Affairs CMC – BiologicsBoston, Massachusetts$242,000–$313,500 / yearDemonstrate 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. Act 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.
Regulatory Affairs Specialist Integrated Resources, IncRegulatory Affairs SpecialistMansfield, MassachusettsContractorRoles and Responsibilities: The skills required include a Regulatory Affairs contracted professional with experience working on product development teams, familiarity with FDA regulations for medical devices, submission experience of 510(k)s, generation of files necessary for outside U.S. notification and registration of medical devices, pre-clinical and/or clinical research, familiarity with ISO 14971, U.S. regulation 21 CFR 820, EC Directives 93/42/EEC as amended by Directive 2007/47/EC, EN ISO 13485, an understanding of basic safety requirements for medical devices, knowledge of current trends within U.S. and European medical device regulations, and intimate knowledge of regulations regarding reprocessing of medical devices in the U.S. Provide regulatory assessments of manufacturing, design, material, and labeling changes. The major deliverables are generally regulatory assessments, US letter to file (RAD), global regulatory strategy plans (GRSP), collaboration with RA International team to determine impact, and collaboration with the project team to review DHF documentation including but not limited to test protocols and reports.
Senior Manager, Regulatory Affairs Avalyn PharmaSenior Manager, Regulatory AffairsBoston, MassachusettsA minimum of 5-8 plus years of regulatory affairs experience within the pharmaceutical, biotechnology, or combination product industry, with operational support of global clinical trials, and direct authorship of regulatory submissions for investigational and commercial products. AP01 has demonstrated encouraging safety and clinical activity across Phase 1b and an ongoing, multi-year open-label extension trial, with long-term data supporting the potential to preserve lung function while improving tolerability relative to historical oral pirfenidone.
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.