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.
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.
Executive Director, Regulatory Affairs Strategy - Cell Therapy AstraZeneca PlcExecutive Director, Regulatory Affairs Strategy - Cell TherapyBoston, MA$276,000–$414,000 / yearMilestone Delivery and Dossier Excellence: Be accountable for delivery of all project-related regulatory milestones, including probability of regulatory success assessments, mitigation planning, approval strategy, lifecycle planning; lead preparation of regulatory strategy documents and target product labeling; ensure strong strategic planning and construction of the global dossier and core prescribing information; oversee maintenance and compliance for marketed brands where applicable. GRST Leadership and Talent Development: Lead one or more Global Regulatory Strategy Teams focused on indications, programs, or franchise priorities; provide leadership, coaching, and performance feedback; line-manage 3-7 regulatory team members; contribute to succession planning, capability building, and development of senior regulatory talent.
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.
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 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.
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.
Manager, Regulatory Affairs Monte Rosa Therapeutics IncManager, Regulatory AffairsBoston, MAResearches 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.
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.
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.
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 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.
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.
Regulatory Affairs Manager. Integrated Resources, IncRegulatory Affairs Manager.Lexington, MassachusettsFull timePrimary 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. Key Skills and Competencies: Knowledgeable in ICH guidelines, Latin American CMC and core dossier requirement.
Prin Regulatory Affairs Spec Medtronic PlcPrin Regulatory Affairs SpecBoston, MAIf you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. 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).
NewRegulatory Affairs Manager Actalent IncRegulatory Affairs ManagerWatertown, MA$70–$75 / hourReporting to the Senior Director of Regulatory Affairs, you will help drive high-quality regulatory submissions and contribute directly to the advancement of a pipeline focused on novel, genetics-informed precision medicines for immunological and inflammatory disorders. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
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.
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.
Director, Regulatory Affairs Thermo Fisher Scientific IncDirector, Regulatory AffairsMA$175,000–$219,000 / yearWe provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy.