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1 week ago Be among the first 25 applicantsThis range is provided by GQR. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.Base pay range$165,000.00/yr - $200,000.00/yrKey Responsibilities:Define and deliver regulatory strategy for assigned programs, ensuring alignment with clinical development plansPrepare and lead the submission of global clinical trial applications (INDs, CTAs) and future marketing applications (e.g., BLAs)Identify potential regulatory risks and proactively develop mitigation or contingency plansEnsure completeness, quality, and consistency across all regulatory submissionsStay current on evolving global regulations (FDA, EMA, ICH) and assess implications for programsPartner internally to influence regulatory planning and execution across disciplinesQualifications:BA/BS in Life Sciences required; MS preferred8–12 years of regulatory affairs and pharmaceutical development experienceStrong experience preparing and leading global submissions for clinical and late-stage programsKnowledge of regulatory frameworks (FDA, EMA, ICH) and eCTD structureExcellent strategic thinking, communication, and cross-functional collaboration skillsAbility to thrive in a fast-paced, science-driven environmentSeniority levelSeniority levelMid-Senior levelEmployment typeEmployment typeFull-timeJob functionJob functionWriting/Editing and Strategy/PlanningIndustriesBiotechnology Research and Pharmaceutical ManufacturingReferrals increase your chances of interviewing at GQR by 2xInferred from the description for this jobMedical insuranceVision insurance401(k)Paid maternity leavePaid paternity leaveStudent loan assistanceTuition assistanceDisability insuranceGet notified when a new job is posted.Sign in to set job alerts for “Director of Regulatory Affairs” roles.Waltham, MA $177,000.00-$336,000.00 1 week agoBoston, MA $200,000.00-$300,000.00 1 day agoGreater Boston $172,521.00-$249,862.00 3 days agoRegulatory Affairs Director, Global Regulatory StrategyBoston, MA $186,232.80-$279,349.19 2 weeks agoSenior Director/Director of Regulatory AffairsSenior Director, Global Regulatory AffairsGreater Boston $210,000.00-$270,000.00 1 day agoPioneering Medicines: Senior Director, Regulatory AffairsVice President, Regulatory Affairs (Clinical)Associate Director, Global Regulatory AffairsBoston, MA $153,600.00-$241,340.00 2 weeks agoDirector, US Regulatory Affairs - Advertising and PromotionCambridge, MA $172,500.00-$249,166.66 1 day agoLexington, MA $264,200.00-$362,000.00 2 weeks agoDirector, Global Regulatory Affairs (GRA) – CMCExecutive Director, Regulatory Affairs & Quality Assurance.Associate Director, Global Regulatory Affairs, Advertising and PromotionBoston, MA $153,600.00-$241,340.00 2 weeks agoWe’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr GQR

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