Senior Director Regulatory Affairs Liaison- General Medicine Merck & Co IncSenior Director Regulatory Affairs Liaison- General MedicineBoston, MA$190,800–$300,300 / yearRequired Skills: Corporate Commercial, Cross-Cultural Awareness, Drug Development, Exercises Judgment, Global Health, Global Market, Healthcare Innovation, Interpersonal Relationships, In Vitro Diagnostics (IVD), Multiple Therapeutic Areas, Oral Communications, Orphan Drugs, Pharmaceutical Regulatory Affairs, Process Improvements, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Issues, Regulatory Management, Regulatory Strategy Development, Written Communication. As the Global Regulatory Lead (GRL), the Senior Principal Scientist functions as the regulatory single, accountable, global point of contact on the project team and interacts with the global regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more company investigational and marketed drugs/biologics in early- and/or late-stage development.
Staff Regulatory Affairs Associate (Digital Health & AI Technologies) WhoopStaff Regulatory Affairs Associate (Digital Health & AI Technologies)Boston, Massachusetts$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.
Manager, Regulatory Affairs Program Canadian Nuclear Laboratories LtdManager, Regulatory Affairs ProgramBurlington, MAManaging the work of and leading technical specialists within the Branch, elsewhere within CNL, and external to CNL (as required) to ensure that requests for independent technical review of technical documentation submitted by Proponents, or requests by Proponents for independent review of activities at nuclear facilities at CNL sites, are accommodated and dispositioned effectively and efficiently with due regard to timely review while maintaining technical breadth and depth and not compromising safety. In consultation with the SRC Secretariat and Proponents, planning independent technical reviews, accepting hazard categories following the review of proposals by Proponents, liaising with the NCS Panel Chair and the NCS Panel Technical Secretary, chairing SRC independent technical review meetings, and ensuring that final review comments that are compiled from SRC technical reviewers are consistent and harmonized before they are sent to the Proponents.
Assoc. Director, Regulatory Affairs Advertising and Promotion Definium Therapeutics IncAssoc. Director, Regulatory Affairs Advertising and PromotionBoston, MA$160,000–$190,000 / yearOur lead product candidate, lysergide tartrate (our proprietary orally disintegrating tablet form of lysergide (LSD) D-tartrate), represents a highly differentiated, potential best-in-class opportunity for patients suffering from generalized anxiety, major depressive disorder, and posttraumatic stress disorder. Provides input into labeling strategies for investigational and marketed products and is responsible for leading interactions with the FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotion Labeling Branch (APLB) pertinent to assigned brand(s).
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.
Associate Director / Director, Regulatory Affairs Treeline Biosciences IncAssociate Director / Director, Regulatory AffairsWatertown, MAContribute 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.
Principal Regulatory Affairs Specialist Cardinal Health IncPrincipal Regulatory Affairs SpecialistMansfield, MARemote$80,900–$127,050 / yearThis includes being a regulatory lead for change development projects, new product development, change assessment, US, EU and international regulatory submissions, commercial support, manufacturing support, compliance related activities, systems improvement, and other responsibilities aligned with global medical device regulations and the goals of the Medical Solutions business. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity.
Associate Director Global Regulatory Affairs - Cambridge, MA 02142 Hybrid 2 days onsite per week Alpha Business SolutionsAssociate Director Global Regulatory Affairs - Cambridge, MA 02142 Hybrid 2 days onsite per weekCambridge, MA$125–$130 / hourIdeal Candidate: The ideal candidate is a senior regulatory labeling professional with strong biologics labeling experience, hands-on expertise with CCDS, USPI, and EU SmPC, and the ability to lead cross-functional labeling strategy. Team Structure: The Global Labeling Strategy team currently consists of four Labeling Strategists and is supported by Labeling Operations Leads and the broader Global Regulatory Affairs organization.
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.
Senior Regulatory Affairs Specialist Boston Scientific CorpSenior Regulatory Affairs SpecialistMarlborough, MAThe anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com-will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Your responsibilities will include: Reviews change notifications and performs regulatory impact assessment for product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings, and supports associated global submissions as needed.
Contract Specialist, Regulatory Affairs (Tewksbury, MA, US, 01876) Corning IncContract Specialist, Regulatory Affairs (Tewksbury, MA, US, 01876)Tewksbury, MA$71,252–$97,972 / yearOur health and well-being benefits include medical, dental, vision, paid parental leave, family building support, fitness, company-paid life insurance, disability, disease management programs, paid time off, and an Employee Assistance Program (EAP) to support you and your family. Today, we accelerate and transform life sciences, mobile consumer electronics, optical communications, display, automotive, and solar markets.
Director Regulatory Affairs Acushnet Holdings CorpDirector Regulatory AffairsMassachusetts, MA$150,447–$195,613 / yearPartnering closely with Senior Leadership, Legal, Operations, Engineering, R&D, and external agencies, the Director oversees environmental permitting, hazardous materials management, site remediation, transportation compliance, chemical control programs, and health and safety initiatives. This role provides enterprise-wide leadership in developing and implementing compliance programs that support operational excellence while minimizing business risk and maintaining adherence to applicable federal, state, local, and international regulations.
Associate Director Regulatory Affairs, Oncology GSK plcAssociate Director Regulatory Affairs, OncologyWaltham, MA$138,750–$231,250 / yearThis role will ensure the development of appropriate global and/or regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy /Integrated Asset plan to ensure the development program meets the needs of the key markets identified and the Medicines Profile. Work with the Early/Medicine Development Team (EDT/MDT) or GRL, to ensure a robust regulatory strategy is in place to support the development program to meet the needs of the key markets identified in the Integrated Asset plan and the Medicine Profile.
Associate 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.
Principal Regulatory Affairs Specialist Boston Scientific CorpPrincipal Regulatory Affairs SpecialistMarlborough, MAActs as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review. The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com-will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role.
Director, 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.
Sr Regulatory Affairs Specialist Foundation Medicine IncSr Regulatory Affairs SpecialistBoston, MA$101,440–$126,800 / yearWrite, prepare, edit and review regulatory submissions to expand indications of currently marketed products; documents include, but are not limited to: Significant Risk Determination Requests (SRDs); IDE applications; Q-Submissions; Pre-market applications (PMAs, sPMAs); and, Performance Study Applications. Preferred Qualifications: Direct experience working with the Center for Devices and Radiological Health (CDRH), including writing and submitting pre-sub, IDE application and/or PMA documents to FDA and other health authorities.
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.
VP or SVP, Regulatory Affairs Acrivon Therapeutics IncVP 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.
Senior Regulatory Affairs Specialist Meridian Bioscience IncSenior Regulatory Affairs SpecialistNorth Billerica, MA$101,600–$131,900 / yearResponsible for supporting regulatory activities regarding released product, including, MDR investigations submissions, post market risk assessments (HHA), supports maintenance of the product Technical File in support of CE Marking, and risk management file updates. Provides regulatory input and oversight to product lifecycle planning, including risk management activities, and monitors product lifecycle and compiles information associated with changes as directed.