Regulatory Affairs Consultant
Position: Senior Manager, Regulatory Affairs Location: Remote We are seeking an experienced Senior Manager, Regulatory Affairs to support global regulatory activities and key submission deliverables for our growing biotech organization. This role is well-suited for someone who is hands-on, highly organized, and comfortable working in a lean, fast-paced environment. Key Responsibilities • Support global regulatory strategy and execution for U.S. and ex-U.S. programs. • Lead and coordinate IND/CTA submissions, protocol amendments, and responses to health authority queries. • Manage submission timelines, tracking tools, and cross-functional project coordination. • Collaborate closely with Clinical, CMC, Nonclinical, and external vendors to ensure high-quality regulatory deliverables. • Assist with document authoring, QC review, and submission-readiness activities. • Knowledge of U.S. regulatory submissions and eCTD format is strongly preferred. Requirements • 3+ years of Regulatory Affairs experience within biotech or pharma. • Experience preparing and supporting U.S. submissions (INDs, amendments, meeting packages). • Strong project management skills with the ability to drive timelines and deliverables. • Ability to work independently and effectively within a small, dynamic biotech environment. • Excellent communication, organizational skills, and strong attention to detail. • Biological logic development • An important requirement is a small-molecule drug development experience. Thanks Vimal JeevaApply Now
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