Detail-oriented and result-driven regulatory affairs professional with a strong foundation in pharmaceutical sciences and hands-on experience in drug development, commercialization, CMC documentation, and regulatory compliance. Certified in Pharmaceutical Regulatory Affairs with in-depth knowledge of global regulatory frameworks, submission requirements, ICH guidelines, and post-approval change management. Proficient in technical writing, and preparation of high-quality regulatory submission documents, including gap assessments, SOP authoring, and audit-readiness and quality system documentation. Seeking a Regulatory Affairs Associate/Specialist position to leverage expertise in CMC regulatory strategy, technical documentation, and com