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.
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 CMC CRISPR Therapeutics AGAssociate Director, Regulatory Affairs CMCSouth Boston, MA$165,000–$180,000 / yearThe Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY (exagamglogene autotemcel [exa-cel]), the world's first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia. You will work in close collaboration with CMC and global development teams, and with relevant external parties including contract manufacturing organizations, expert consultants, development partners, and global health authorities.
NewExecutive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product 3316 Takeda Development Center AmericasExecutive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination ProductBoston, MassachusettsAs Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product, you will provide strategic leadership and development to global regulatory subject matter experts to ensure innovative and robust regulatory strategies for medical devices and drug-device combination products, maximizing global regulatory success and minimizing time to approval/clearance. Leads and develops a team of regulatory leaders and subject matter experts, overseeing global regulatory strategy and major submissions for an assigned portfolio of medical devices and drug-device combination products, ensuring clear strategy, high-quality execution, and timely approvals/clearances.
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.
NewExecutive Director, Global Regulatory Affairs CMC Early Development 3316 Takeda Development Center AmericasExecutive Director, Global Regulatory Affairs CMC Early DevelopmentBoston, MassachusettsAccountable 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).
Manager, Rates And Regulatory Affairs Liberty UtilitiesManager, Rates And Regulatory AffairsLondonderry, NHManages the development of strategies associate with revenue requirements, cost recovery, rate making, customer programs, and gas/electric/water rate issues. At Algonquin, our vision is to be the most trusted utility service provider in North America - a premium regulated utility, known for our customer focus, commitment to sustainability, and strong community partnerships.
Global Regulatory Affairs (CMC) Manager Integrated Resources, IncGlobal Regulatory Affairs (CMC) ManagerLexington, MassachusettsContractorJob Function and Description: • Provide regulatory support, guidance and expertise to internal groups such as product development, QA, QC and manufacturing teams to ensure that all applicable regulatory requirements are considered and appropriately incorporated into development programs and that products are developed and manufactured in compliance with appropriate regulations and guidelines so that they be studied and marketed as planned. Under the direction of the Director of Regulatory Affairs direct and manage Regulatory Affairs activities for developing global CMC strategies across product life cycles & execution in North America.
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.
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.
Executive 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.
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.
Regulatory affairs Manager Integrated Resources, IncRegulatory affairs ManagerLexington, MassachusettsFull timeExperience Requirements: • Minimum of 5 years + experience in drug development and registration activities, including personal management of an approved new drug from initial development through to approval and market launch. Must have skill-set Job Function and Description: • Serve as the senior and principal regulatory affairs member of project development teams, primarily focused on (but not limited to) drug products.
Regulatory Affairs Manager Integrated Resources, IncRegulatory Affairs ManagerLexington, MassachusettsContractorMust have skill-set [Job Description] Job Function and Description: • Serve as the senior and principal regulatory affairs member of project development teams, primarily focused on (but not limited to) drug products. • Minimum of 5 years + experience in drug development and registration activities, including personal management of an approved new drug from initial development through to approval and market launch.
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.
NewDirector, Global Regulatory Affairs CMC 3316 Takeda Development Center AmericasDirector, Global Regulatory Affairs CMCBoston, MassachusettsThis 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) and may serve as the GRA CMC Product Lead, as required. 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.
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.
NewAssociate 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.