Regulatory Affairs Consultant

Direct message the job poster from Barrington JamesSeeking a Regulatory Affairs Contractor (Associate Director, Global Regulatory Affairs) based along the East Coast. In this role, you will contribute to the development and execution of regulatory strategy, support global submissions, and ensure compliance across all phases of drug development. This position requires strong collaboration with cross-functional teams and regulatory authorities, with a focus on advancing new drug development and commercialization.Key Responsibilities:Lead and implement regulatory strategy for assigned projects across all development phases.Prepare and manage INDs, CTAs, NDAs, MAAs, and related submissions.Collaborate with partners to align submission timelines and risk mitigation plans.Represent the company in meetings with regulatory terpret scientific data in support of regulatory requirements and strategy.Provide leadership and guidance to cross-functional teams and global regulatory project teams.Support development of GRA processes and systems to improve efficiency.Qualifications:Bachelor’s degree in a scientific discipline (advanced degree preferred).6+ years of Regulatory Affairs experience in drug development and registration (small molecule or biologics).Proven track record with global submissions (EU, international markets).Rare disease and pediatric drug development experience strongly preferred.Excellent communication, teamwork, and leadership skills.Strong project management and computer skills.Seniority levelSeniority levelDirectorEmployment typeEmployment typeContractJob functionJob functionProject Management, Research, and Strategy/PlanningIndustriesPharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment ManufacturingReferrals increase your chances of interviewing at Barrington James by 2xGet notified about new Regulatory Affairs Consultant jobs in Boston, MA.Manager, Global Regulatory Affairs, OncologyWaltham, MA $134,250.00-$223,750.00 3 days agoMarlborough, MA $113,700.00-$189,400.00 3 days agoAssociate Director, Global Regulatory AffairsBoston, MA $153,600.00-$241,340.00 1 day agoManager, External and Regulatory AffairsSr. Regulatory Affairs Specialist (Austin, TX)Burlington, MA $100,000.00-$110,000.00 1 week agoSenior Regulatory Affairs Specialist (IVD Exp. supporting US/Health Canada)Boston, MA $87,892.99-$118,774.78 2 weeks agoAssociate Director, Regulatory Affairs StrategyCambridge, MA $149,069.00-$223,604.00 2 months agoCambridge, MA $114,000.00-$152,000.00 2 days agoGlobal Regulatory Affairs Operations and Planning LeadCambridge, MA $250,000.00-$290,000.00 4 days agoAssociate Director, Global Regulatory Affairs - GI & InflammationBoston, MA $153,600.00-$241,340.00 2 weeks agoAssociate Director, Global Regulatory Affairs – Global Labeling StrategyCambridge, MA $147,000.00-$212,333.33 2 weeks agoAssociate Director, Global Regulatory Affairs, CMC Small MoleculesBoston, MA $153,600.00-$241,340.00 3 days agoAssociate Director, Global Regulatory Affairs, Advertising and PromotionAssociate Director, Regulatory Affairs, Advertising and PromotionAssociate Director, Global Regulatory AffairsBoston, MA $153,600.00-$241,340.00 2 weeks agoSenior Principal, Regulatory Affairs - Companion DiagnosticsBoston, MA $200,000.00-$240,000.00 2 days agoSenior Director, Global Regulatory Lead, GI & InflammationAssociate Director, Global Regulatory Affairs - GI & InflammationAssociate Director, Global Regulatory Affairs, CMC Small MoleculesWe’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr

Created: 2025-09-17