Sr Regulatory Affairs Manager

3 weeks ago

Round Lake, United States Gandiv Insights LLC Full time

We’re looking for a seasoned Regulatory Affairs professional to lead global nonclinical and clinical regulatory strategy for programs across their full lifecycle. This high-impact role partners with cross-functional leaders, guides Health Authority engagement, and drives critical global submissions. What You’ll Do Lead development and execution of global nonclinical & clinical regulatory strategy aligned with CDP and corporate goals Serve as a key regulatory partner to clinical, nonclinical, and regional regulatory teams Drive strategy and content for FDA and global Health Authority meetings, serving as primary FDA contact Oversee clinical and nonclinical contributions to IND/CTA submissions and maintain global filings Lead preparation of CTD/global dossier content for Marketing Applications, supporting review through approval Incorporate global HA feedback, support lifecycle expansion, and ensure compliance with pediatric plan requirements Collaborate with CROs and internal SMEs to support global clinical trial execution Ensure timely posting of clinical trial results on ClinicalTrials.gov What You Bring Degree in a life science discipline (PhD preferred; MS/BS with strong experience welcomed) ~8+ years of Regulatory Affairs experience with nonclinical/clinical focus Proven success leading regulatory strategy and Health Authority interactions Strong understanding of global IND/CTA and MA requirements If you thrive in strategic roles at the intersection of science, regulatory policy, and global development—we’d love to connect. 📩 Interested? Message me or share your resume anupam@gandivainsights.com #J-18808-Ljbffr

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