Remote Regulatory Scientist

Summary

Join our dynamic team as a Regulatory Scientist and make a real impact in shaping the future of life-changing therapies. This hybrid role offers the flexibility of in-office and remote work, allowing you to thrive in a collaborative environment while maintaining a healthy work-life balance.

Requirements

• A passionate regulatory affairs professional with a proven track record in eCTD submissions and a deep understanding of health authority interactions, regulations (21 CFR, FDA, ICH), and application processes
• BS/BA in Regulatory Sciences or Life Sciences
• Embody our core values – People, Innovation, Passion and Excellence
• Possess a meticulous eye for accuracy and strong organizational skills
• Thrive in a collaborative environment and demonstrate excellent communication skills

Responsibilities

• Partner with US and international clients to design and implement regulatory and CMC strategies for the development of new drugs and/or combination products (drug/drug or drug/device)
• Craft and review regulatory documents to the highest standards, compiling dossiers for FDA and global submissions (INDs, NDAs, BLAs, ANDAs, DMFs, supplements, IMPDs, etc.)
• Advise clients on regulatory strategy and submissions based on the latest regulatory agency (e.g. FDA, EU, ICH, etc.) guidelines
• Interpret and apply regulations to specific project challenges, including identifying necessary amendments and supplements
• Effectively manage multiple projects, keeping teams and clients informed with clear communication and established timelines
• Gain valuable mentorship from senior regulatory professionals and collaborate with our document management team to deliver exceptional results

Preferred Qualifications

• RAC certification and/or an MS/Ph.D
• Experience in a consulting environment
• Experience with eDRLS submissions