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Direct message the job poster from Axion Search Location: Boston area preferred (Hybrid/Remote options considered) Travel: Up to 10% domestic/international An established biopharmaceutical company is seeking an experienced Regulatory Affairs to lead and execute the planning, preparation, and maintenance of regulatory submissions across global programs. This role offers a strategic and hands-on opportunity to guide programs through development and potential commercialization stages. Key Responsibilities: Serve as the Regulatory Affairs lead on cross functional drug development teams, providing strategic input and guidance on global regulatory requirements. Oversee and contribute to the preparation, submission, and lifecycle management of key regulatory documents including INDs, NDAs, CTAs, DMFs, amendments, safety reports, and annual reports. Act as primary point of contact for regulatory agency interactions, including FDA and other global health authorities. Partner with clinical, nonclinical, CMC, safety, and other functions to align regulatory strategy with program goals. Interpret and communicate regulatory requirements to internal teams and external partners including CROs, CMOs, and consultants. Provide regulatory input to pharmacovigilance activities as required. Qualifications: Bachelor’s or Master’s degree in a life sciences or health-related field. 10+ years of regulatory affairs experience within the biopharma industry. Demonstrated experience with U.S. and global regulatory submissions, including hands-on authoring and publishing (eCTD experience required). NDA and global marketing application experience highly desirable (e.g., MAA, NDS). Strong working knowledge of FDA regulations and ICH guidelines. Experience supporting global clinical trials is preferred. Exceptional written and verbal communication skills. Self-directed, collaborative, and comfortable in a fast-paced, team-driven environment. To learn more or express interest confidentially, please reach out directly. Boston area candidates preferred, though flexibility may be available for exceptional remote talent. Seniority level Seniority level Director Employment type Employment type Full-time Job function Job function Management and Strategy/Planning Industries Biotechnology Research and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Axion Search by 2x Sign in to set job alerts for “Director of Regulatory Affairs” roles. Boston, MA $300,000.00-$380,000.00 3 weeks ago Associate Director/Director, Regulatory Affairs Senior Director/Director of Regulatory Affairs Vice President, US Regulatory Affairs & Quality Senior Director, Global Regulatory Affairs Boston, MA $172,521.00-$249,862.00 1 month ago Boston, MA $200,000.00-$230,000.00 2 weeks ago Senior Director, Global Regulatory Affairs Greater Boston $172,521.00-$249,862.00 2 weeks ago Senior Director Global Regulatory Affairs – Global Regulatory Lead – Neuroscience Boston, MA $208,200.00-$327,140.00 2 weeks ago Associate Director, Global Regulatory Affairs Boston, MA $153,600.00-$241,340.00 4 weeks ago Acton, MA $169,275.00-$253,912.50 1 week ago Senior Director Global Regulatory Affairs – Global Regulatory Lead – Neuroscience Boston, MA $208,200.00-$327,140.00 2 weeks ago Executive Director/Vice President, Regulatory Affairs Associate Director, Global Regulatory Affairs Boston, MA $153,600.00-$241,340.00 5 days ago Director, Global Regulatory Affairs – Global Labeling Strategy Cambridge, MA $172,500.00-$249,166.66 2 weeks ago Pioneering Medicines: Senior Director, Regulatory Affairs Cambridge, MA $246,330.00-$304,290.00 1 week ago Associate Director, Global Regulatory Affairs, Advertising and Promotion Boston, MA $153,600.00-$241,340.00 2 days ago Director, Global Regulatory Affairs, Neuroscience Associate Director, Global Regulatory Affairs - GI & Inflammation Boston, MA $153,600.00-$241,340.00 3 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr