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.
NewManager, 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.
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.
NewVice President, Regulatory Affairs, SS Integra LifeSciences Holdings CorpVice President, Regulatory Affairs, SSBillerica, MA$225,400–$316,250 / yearDemonstrated success developing and executing regulatory strategies within the MedTech industry, preferably for specialty surgery, implantable devices, neurosurgical, reconstruction, biologics, combination products, or related product portfolios, including experience with complex submissions such as Class III PMA, IDE, pre-submissions, 510(k)s, technical files, design dossiers, or international registrations. This role partners with Global Regulatory Affairs leadership, Specialty Surgery business leaders, Quality, Operations, Product Development, Commercial, Legal, Medical Affairs, and other stakeholders to develop and execute regulatory strategies that support product development, submissions, lifecycle management, advertising and promotion review, and global registrations for the division.
NewVice President, Regulatory Affairs, Specialty Surgery Integra LifeSciences Holdings Corp.Vice President, Regulatory Affairs, Specialty SurgeryBillerica, MA$225,400–$316,250 / yearDemonstrated success developing and executing regulatory strategies within the MedTech industry, preferably for specialty surgery, implantable devices, neurosurgical, reconstruction, biologics, combination products, or related product portfolios, including experience with complex submissions such as Class III PMA, IDE, pre-submissions, 510(k)s, technical files, design dossiers, or international registrations. This role partners with Global Regulatory Affairs leadership, Specialty Surgery business leaders, Quality, Operations, Product Development, Commercial, Legal, Medical Affairs, and other stakeholders to develop and execute regulatory strategies that support product development, submissions, lifecycle management, advertising and promotion review, and global registrations for the division.
NewVice President, Regulatory Affairs *PC 884 Miltenyi Biotec GmbHVice President, Regulatory Affairs *PC 884Waltham, MA$295,600–$347,764 / yearYour Role: The role will be responsible to lead the regulatory strategy for US Biomedicine efforts in alignment with global efforts.?The role will oversee industry-specific practices, ensure all government and company regulations are being met, assessing regulatory risks and interfacing with regulatory authorities to ensure the company meets all set requirements and guidance's. Lead team members that provide regulatory affairs content and requirements for regulatory submissions and review this content for conformance with established requirement.?Manage and develop staff, if required, including staff professional development and project oversight accountability.?.
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 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.
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.
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.
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 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.
Project Specialist I, Rates And Regulatory Affairs Liberty UtilitiesProject Specialist I, Rates And Regulatory AffairsLondonderry, NHAssist with the discovery request process for regulatory proceedings, including assignment of discovery responses, preparation of electronic templates, coordination of responses and response review, and review, prepare and finalize discovery responses electronic form and hard copy as needed. Assist in managing the database for compliance filings and follow up with business leads to ensure timely and accurate submission of pertinent filings while ensuring accuracy of filings and adherence to applicable filing requirements.
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.
Director or Senior Director, Regulatory Affairs Kymera TherapeuticsDirector or Senior Director, Regulatory AffairsWatertown, MA$195,000–$330,000 / 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. Act as the global regulatory strategy lead for Kymera's IRF5 degrader program, developing and driving the overall program regulatory strategy across multiple immunology and inflammation (I/I) indications.
Executive Director, Regulatory Affairs Dyne TherapeuticsExecutive Director, Regulatory AffairsWaltham, MA$250,000–$310,000 / yearThe Executive Director, Regulatory Affairs serves as a visionary leader who shapes long-term program regulatory strategy, collaborates on regulatory functional strategy, and drives organizational impact across Dyne's regulatory operations. L everag e deep company knowledge to foster innovation, guide functional managers and leaders in embedding purpose, accountability, and emotional intelligence into operations, and model Dyne's values through leading with commitment and resolve .
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.
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.
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.