A highly driven and results-oriented pharmaceutical professional with over 15 years of experience across all phases of drug development and post-marketing. Skilled in both regulatory affairs and quality assurance, with a deep understanding of business insights that complement technical expertise.I am passionate about providing regulatory support for both innovative and generic molecules, guiding clients from feasibility assessments through to post-approval lifecycle management. My expertise lies in developing global CMC regulatory strategies with a focus on innovation, ensuring competitive business advantages while maintaining stringent regulatory compliance.Key Competencies:• Regulatory Submissions: Proficient in handling submissions across various global regulatory frameworks, including ANDA, NDA, IND, ANDS, and MAA applications. Extensive experience in preparing and managing eCTD submissions for a wide range of dosage forms.• Post-Approval Submissions: Hands-on experience in responding to regulatory queries, managing variations, Annual Reports, PADER, Product Renewals, and other post-approval activities.• Ad-Hoc Regulatory Services: Expertise in Controlled correspondence submissions, Facilities Registration (FEI and DUNS numbers), Labeler Code Application (NDC), SPL Preparation, and Establishment Registrations and renewals.• Regulatory Due Diligence: Skilled in conducting comprehensive regulatory due diligence for prospective and incoming acquisitions, ensuring a thorough assessment of regulatory risks and opportunities.• Product Development & Quality: Deep knowledge of Product Development, Quality by Design (QBD), and Quality Management System (QMS) principles, enabling a holistic approach to regulatory strategy.My goal is to help clients navigate the complex regulatory landscape with ease, leveraging my extensive experience to deliver innovative solutions that drive success.