Hiring: US Regulatory Affairs Lead | 100% Remote | 6-Month Contract
📢 We’re Hiring: US Regulatory Affairs Lead | 100% Remote | 6-Month Contract Are you an experienced Regulatory Affairs professional with strong knowledge of US FDA regulations and drug development submissions? This could be an excellent opportunity to make an impact in the pharmaceutical and oncology space. We’re seeking a US Regulatory Affairs Lead to support regulatory strategy, submission activities, and cross-functional collaboration for innovative pharmaceutical programs. 🔹 Position: US Regulatory Affairs Lead 🔹 Location: 100% Remote – US 🔹 Contract Duration: 6 months, with potential extension 🔹 Schedule: Monday–Friday, 40 hours per week 🔹 Preferred Time Zone: Eastern Time (ET) 🔹 Travel: Little to no travel expected
Key Responsibilities
Support US regulatory strategy and execution for new products and indication expansions. Prepare and contribute to FDA meeting materials, regulatory research, and regulatory intelligence. Lead or support IND, NDA, and BLA submissions to the US FDA. Collaborate with Clinical, Global Regulatory, and other cross-functional teams. Develop and coordinate regulatory submission processes and documentation. Support regulatory assessments of external innovation opportunities. Required Qualifications ✅ Bachelor’s degree in a relevant scientific discipline; advanced degree preferred. ✅ 7–10+ years of Regulatory Affairs experience in the pharmaceutical or biotechnology industry. ✅ Strong knowledge of US FDA regulatory requirements and submission procedures. ✅ Hands-on experience with IND, NDA, and/or BLA submissions. ✅ Strong communication, project management, and cross-functional collaboration skills. Who Should Apply? Experienced US Regulatory Affairs professionals with a background in drug development, FDA submissions, regulatory strategy, and pharmaceutical product lifecycle management. 📩 Interested or know someone who might be a great fit? Please send me a direct message with your updated resume or share this post with qualified professionals in your network. Let’s connect! #Hiring #RegulatoryAffairs #RegulatoryAffairsJobs #FDA #USFDA #IND #NDA #BLA #PharmaceuticalJobs #BiotechJobs #RemoteJobs #ContractJobs #LifeSciences #Oncology