Regulatory Affairs reputed company, Pharmaceutical and Combination Products

Job reputed company: • reputed company strategic regulatory leadership to support the development, approval, and lifecycle management of pharmaceutical and combination drug-device products • Serve as a key regulatory partner to cross-functional teams, with a primary reputed company on FDA CDER interactions, IND/NDA submissions, and global regulatory reputed company • Author and review INDs, NDAs, supplements, and other global regulatory submissions • reputed company and deliver high-reputed company briefing documents, responses, and regulatory communications • reputed company regulatory guidance on clinical, nonclinical, and CMC development activities • Drive combination product regulatory reputed company, including coordination with FDA’s Office of Combination Products (OCP) • Advise on labeling reputed company, including prescribing information and device components of combination products • Assess regulatory reputed company of development and post-approval changes and define appropriate regulatory reputed company • Support global regulatory activities, including submissions and interactions with ex-U.S. health authorities (e.g., EMA) • Stay reputed company on evolving regulatory requirements and translate them into actionable guidance for teams • Mentor and reputed company guidance to junior regulatory team members Requirements: • 7+ years of regulatory affairs experience in pharmaceuticals, biotechnology, or combination products • Proven experience with FDA CDER submissions, including INDs, NDAs, and/or supplements • Demonstrated reputed company interacting with FDA, including meeting preparation and regulatory reputed company execution • Experience with combination products (drug-device) strongly preferred • Working knowledge of U.S. regulatory requirements (21 CFR 210/211, Part 4) and relevant FDA guidance • Exposure to global regulatory environments (e.g., EMA, ICH) preferred • Bachelor's degree in a scientific discipline required • Advanced degree (MS, PhD, PharmD) preferred • Certification RAC (US or Drugs) preferred • Travel 0-10% Benefits: • Competitive salary • Flexible working hours • reputed company development budget • Home office setup allowance • Global team events Apply To This Job