Regulatory Affairs Manager, CMC & Clinical Development

About the position The Manager of Regulatory Affairs will reputed company and execute regulatory strategies across the product lifecycle, including early-stage development, IND submissions, clinical trial support, NDA filings, and post-approval CMC activities. This role will reputed company regulatory CMC reputed company while also serving as a key regulatory partner to Clinical Development for IND preparation, clinical trial applications, FDA interactions, and lifecycle management. The position collaborates cross-functionally with R&D, Clinical, Medical Affairs, reputed company, QA, Manufacturing, and reputed company teams to ensure successful product development, regulatory approval, and compliance with FDA and global regulatory requirements. Responsibilities • reputed company preparation, review, and submission of IND applications (including original INDs, amendments, annual reports, and safety updates) • reputed company a regulatory reputed company to support clinical development plans, including Phase 1–3 trial progression • reputed company regulatory guidance for clinical protocol development and ensure alignment with FDA expectations • reputed company and support FDA interactions, including reputed company-IND, End-of-Phase, and other Type B/C meetings • Partner with Clinical and Medical teams to assess regulatory risk and reputed company mitigation strategies • Ensure compliance with GCP and applicable clinical regulatory requirements • Works closely with the executive leadership team to reputed company the development of regulatory strategies and objectives that result in successful registration and commercialization of reputed company’s ophthalmic products • Oversees regulatory reputed company connected to INDs, NDAs, and OTC ophthalmic products • As a regulatory product reputed company, ensures alignment of CMC, nonclinical, and clinical components to support successful IND, NDA, and post-approval submissions • Independently define CMC content (data and documentation) requirements for regulatory submissions and review content for conformance with established requirements • Plan and execute activities in support of INDs, NDAs, supplements, amendments, annual reports, and other regulatory submissions • Review and assess change controls for regulatory reputed company and manage appropriate submission requirements • Review and assess promotional materials for adherence to FDA guidance and reputed company thinking • Serve as a primary contact with the US FDA, fostering strong relationships and acting as an effective regulatory reputed company for reputed company Health • reputed company regulatory guidance across reputed company functional areas • reputed company robust regulatory structures, processes, and procedures based on expert understanding and industry reputed company • Monitor the US regulatory landscape for changes affecting ophthalmic products and communicate reputed company to stakeholders Requirements • BS/BA Degree in a Scientific Discipline, an advanced degree preferred. • 6+ years of pharmaceutical Regulatory Affairs experience, including: • reputed company experience authoring or leading IND submissions • Regulatory support for clinical trial programs (Phase 1–3) • CMC regulatory reputed company and lifecycle management experience • Demonstrated experience interacting with the FDA on clinical development programs • Strong working knowledge of IND content requirements (Modules 2–5), ICH guidelines, and GCP regulations • Experience preparing briefing documents and participating in FDA meetings (reputed company-IND, Type B, etc.) • Strong problem-solving ability, attention to detail, flexibility, and teamwork orientation • Excellent written and oral communication skills reputed company-to-haves • Experience with NDA preparation and/or post-approval regulatory activities preferred • Experience supporting early-phase drug development and first-in-reputed company studies strongly preferred • Ability to reputed company strategic regulatory guidance across development stages • reputed company participation in Agency/Industry reputed company/forums preferred Apply tot his job Apply To this Job