Staff Regulatory Affairs Associate (Digital Health & AI Technologies) WhoopStaff Regulatory Affairs Associate (Digital Health & AI Technologies)Boston, MA$170,000–$220,000 / yearAt WHOOP, we view total compensation as the combination of base salary, equity, and benefits, with equity serving as a key differentiator that aligns our employees with the long-term success of the company and allows every member of our corporate team to own part of WHOOP and share in the company's long-term growth and success. Partner with Product, Engineering, and AI/ML teams to evaluate regulatory implications of new features, algorithms, health insights, claims, intended uses, and user experiences, and recommend appropriate regulatory and claims strategies.
Regulatory Affairs Associate Integrated Resources, IncRegulatory Affairs AssociateCambridge, MassachusettsContractorAssociate II Regulatory Affairs Location: Cambridge, MA Duration: 6+ months (possibility of extension) JOB ROLES & RESPONSIBILITIES Regulatory Submissions (CTA) Associate (Sr. Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms.
NewDirector of Regulatory Affairs, Post-Market Compliance WerfenDirector of Regulatory Affairs, Post-Market ComplianceBedford, Massachusetts$200,000–$240,000 / yearFull timeReporting to the Senior Director of Regulatory Affairs, this position is responsible for ensuring worldwide regulatory compliance of commercially distributed products through effective management of vigilance reporting, field actions, post-market surveillance activities, regulatory assessments, and product lifecycle compliance programs. The Director serves as the regulatory leader for post-market compliance activities and collaborates closely with Quality Assurance, Medical Affairs, R&D, Operations, Manufacturing, Supply Chain, and Commercial teams to ensure timely identification, assessment, communication, and resolution of product-related regulatory issues.
NewDirector, Global Regulatory Affairs, Neuroscience 3316 Takeda Development Center AmericasDirector, Global Regulatory Affairs, NeuroscienceBoston, MassachusettsDemonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible.
NewAssociate Director, Global Regulatory Affairs - GI & Inflammation 3316 Takeda Development Center AmericasAssociate Director, Global Regulatory Affairs - GI & InflammationBoston, MassachusettsDemonstrates strong skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
Executive Director, Regulatory Affairs Liaison Merck & Co IncExecutive Director, Regulatory Affairs LiaisonBoston, MA$231,900–$365,000 / yearRequired Skills: Accountability, Accountability, Business Development, Communication, Complaint Management, Cross-Cultural Awareness, External Communication, Global Health, Global Regulatory, Leadership, Oncology Drug Development, Ophthalmology, People Management, Pharmaceutical Regulatory Affairs, Professional Integrity, Project Resource Allocation, Project Tasks, R&D Strategy, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Compliance, Regulatory Experience, Regulatory Filings, Regulatory Strategy Development, Resource Allocation {+ 3 more}. Provide oversight for direct reports and support them to function as the single global point of accountability for assigned projects, partnering closely with international regulatory colleagues and engaging global health authorities to deliver on Company priorities.
NewAssociate Director, Global Regulatory Affairs CMC 3316 Takeda Development Center AmericasAssociate Director, Global Regulatory Affairs CMCBoston, MassachusettsProactively 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. This 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: With minimal supervision, develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products.
Regulatory Affairs Specialist II, Expansion WhoopRegulatory Affairs Specialist II, ExpansionBoston, MA$120,000–$160,000 / yearThis role focuses primarily on international regulatory submissions, EU MDR Technical Documentation, global market registrations, and lifecycle regulatory support while partnering cross-functionally to help bring innovative health technologies to markets around the world. At WHOOP, we view total compensation as the combination of base salary, equity, and benefits, with equity serving as a key differentiator that aligns our employees with the long-term success of the company and allows every member of our corporate team to own part of WHOOP and share in the company's long-term growth and success.
NewAssociate Director Regulatory Affairs Alnylam Pharmaceuticals IncAssociate Director Regulatory AffairsCambridge, MA$170,900–$231,300 / yearThe Associate Director of Regulatory Affairs Strategy will work on assigned programs with the respective Global Regulatory Portfolio Lead, Global Regulatory Lead and cross-functional team to lead and define the regulatory strategy, facilitate submission of data packages to the US FDA and other international health agencies (HA). Additional responsibilities include involvement in thewriting and oversight of regulatory submissions, coordinating all aspects of paper and electronic regulatory submissions, proactively keeping updated on regulatory requirements worldwide, and interpreting regulatory intelligence for the internal teams.
NewAssociate 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–$140,000Under 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.
VP Or Svp, Regulatory Affairs Acrivon Therapeutics Inc.VP Or Svp, Regulatory AffairsWatertown, MAThese distinctive capabilities enable the company to go beyond the limitations of traditional drug discovery, as well as current AI-based target-centric drug discovery and rapidly design highly differentiated compounds with desirable pathway effects through intracellular protein network analyses and advance these agents into the clinic for streamlined development. Acrivon is currently advancing its lead program, ACR-368 (also known as prexasertib), a selective small molecule inhibitor targeting CHK1 and CHK2 in a potentially registrational Phase 2 trial for endometrial cancer.
Associate Director / Director, Regulatory Affairs Treeline Biosciences, Inc.Associate Director / Director, Regulatory AffairsWatertown, MA$175,000–$206,015 / yearContribute to (Associate Director) or hold final accountability for (Director) regulatory documentation, ensuring adherence to FDA and other global health authority specifications and timelines, including submissions, correspondence, and approvals, and ensuring accurate and organized records. Unsolicited resumes sent to Treeline Biosciences from recruiters do not constitute any type of relationship between the recruiter and Treeline Biosciences and do not obligate Treeline Biosciences in any way to pay fees should we hire from those resumes.
CMC Regulatory Affairs Manager Integrated Resources, IncCMC Regulatory Affairs ManagerWaltham, MassachusettsContractorA minimum of 7 years in the Pharmaceutical Industry, and a minimum 5 years regulatory CMC experience (Biologics) • Demonstrate strong organizational skills, including the ability to prioritize personal and direct reports workload. Assess impact on specific projects • Assess compliance of CMC document with the current Guidelines and Regulations • Assess regulatory impact of proposed CMC changes to licenses or clinical trial applications.
Regulatory Affairs Specialist II - Merrimack, NH (Hybrid) Getinge GroupRegulatory Affairs Specialist II - Merrimack, NH (Hybrid)Merrimack, NHWith a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. Prepare state of the art documentation and coordinate activities related to European Union Medical Device Regulation (EuMDR), premarket approvals (PMAs), 510(k) premarket submissions, and investigational device exemptions (IDEs).
Associate Director, Regulatory Affairs Parabilis MedicinesAssociate Director, Regulatory AffairsCambridge, MA$170,000–$195,000 / yearWe are fiercely independent as a leader in defying the limitations of current therapeutic modalities, and interdependent as a team as we work collaboratively to shift drug discovery paradigms and provide patients with better treatment options. Parabilis Medicines is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for patients with serious diseases by unlocking biologically important targets long considered undruggable.
Associate Director, Regulatory Affairs CMC CRISPR TherapeuticsAssociate Director, Regulatory Affairs CMCSouth Boston, MassachusettsThe 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.
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.
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.
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.