Hyderabad, Telangana, India
𝐑𝐞𝐬𝐮𝐥𝐭𝐬-𝐃𝐫𝐢𝐯𝐞𝐧 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐏𝐫𝐨𝐟𝐞𝐬𝐬𝐢𝐨𝐧𝐚𝐥 𝐑𝐞𝐚𝐝𝐲 𝐭𝐨 𝐃𝐫𝐢𝐯𝐞 𝐒𝐮𝐜𝐜𝐞𝐬𝐬. I am a highly motivated and results-driven Regulatory professional with over 16 𝘺𝘦𝘢𝘳𝘴 of experience in the pharmaceutical industry. My journey has been marked by a passion for regulatory processes, covering scientific, policy, and management aspects, making me proficient in the entire regulatory lifecycle. ➟ 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐄𝐱𝐩𝐞𝐫𝐭𝐢𝐬𝐞: ◆ Proficient in scientific, policy, and management aspects of regulatory processes. ◆ Specialized in 𝘯𝘰𝘯-𝘤𝘰𝘮𝘱𝘭𝘦𝘹/𝘤𝘰𝘮𝘱𝘭𝘦𝘹 𝘱𝘢𝘳𝘦𝘯𝘵𝘦𝘳𝘢𝘭𝘴, 𝘕𝘉𝘊𝘋𝘴, 𝘱𝘦𝘱𝘵𝘪𝘥𝘦𝘴, 𝘭𝘪𝘱𝘰𝘴𝘰𝘮𝘦𝘴, 𝘰𝘱𝘩𝘵𝘩𝘢𝘭𝘮𝘪𝘤𝘴, 𝘰𝘵𝘪𝘤𝘴, 𝘢𝘯𝘥 𝘋𝘋𝘊𝘗𝘴. ◆ Track record of success in 𝘭𝘦𝘢𝘥𝘪𝘯𝘨 𝘢𝘯𝘥 𝘮𝘢𝘯𝘢𝘨𝘪𝘯𝘨 regulatory teams. ◆ Skilled in developing and executing 𝘳𝘰𝘣𝘶𝘴𝘵 𝘳𝘦𝘨𝘶𝘭𝘢𝘵𝘰𝘳𝘺 𝘴𝘵𝘳𝘢𝘵𝘦𝘨𝘪𝘦𝘴. ➟ 𝐍𝐚𝐯𝐢𝐠𝐚𝐭𝐢𝐧𝐠 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐓𝐞𝐫𝐫𝐢𝐭𝐨𝐫𝐢𝐞𝐬: ◆ In-depth understanding of regulatory landscapes in the 𝘜𝘚, 𝘌𝘜, 𝘢𝘯𝘥 𝘊𝘢𝘯𝘢𝘥𝘢. ◆ Experience in diverse regulatory submissions, including controlled correspondence, pre-submission, and scientific advice meetings. ◆ Proficient in preparing and reviewing regulatory dossiers for 𝘊𝘎𝘛, 𝘗𝘍𝘊, 𝘢𝘯𝘥 𝘱𝘳𝘪𝘰𝘳𝘪𝘵𝘺 𝘴𝘶𝘣𝘮𝘪𝘴𝘴𝘪𝘰𝘯𝘴. ➟ 𝐏𝐫𝐨𝐯𝐞𝐧 𝐋𝐞𝐚𝐝𝐞𝐫𝐬𝐡𝐢𝐩: ◆ Led and managed regulatory teams with success. ◆ Developed and implemented effective regulatory strategies. ◆ Prepared and reviewed regulatory dossiers for a range of products. ➟ 𝐄𝐟𝐟𝐞𝐜𝐭𝐢𝐯𝐞 𝐂𝐨𝐦𝐦𝐮𝐧𝐢𝐜𝐚𝐭𝐢𝐨𝐧 𝐚𝐧𝐝 𝐑𝐞𝐥𝐚𝐭𝐢𝐨𝐧𝐬𝐡𝐢𝐩 𝐁𝐮𝐢𝐥𝐝𝐢𝐧𝐠: ◆ Expert in communicating with health authorities. ◆ Adept at building relationships with key stakeholders. ➟ 𝐊𝐞𝐲 𝐒𝐤𝐢𝐥𝐥𝐬: ◆ 𝘉𝘶𝘴𝘪𝘯𝘦𝘴𝘴 𝘢𝘤𝘶𝘮𝘦𝘯 and project management. ◆ Strong communication and interpersonal skills. ◆ Ability to grasp scientific and health concepts, 𝘪𝘯𝘧𝘭𝘶𝘦𝘯𝘤𝘪𝘯𝘨 𝘸𝘪𝘵𝘩𝘰𝘶𝘵 𝘢𝘶𝘵𝘩𝘰𝘳𝘪𝘵𝘺. Confident in my ability to contribute significantly to any team, I am enthusiastic about ongoing growth and development in the dynamic field of regulatory affairs.
Product development and Post approval
• Planning and implementation of robust Regulatory strategies for complex generic products such as long acting Injectables, Drug/Device Combination products, Peptides, Otics and Ophthalmics to simplify/minimize the product developments or requirements. • Preparation and submission of Pre-ANDA meeting packages, scientific advice meeting packages and controlled correspondences for complex products to seek guidance/opinions/confirmations from the Regulatory Agencies. • Tracking the Regulatory filing plans to ensure timely, quality submissions and secure first review cycle approvals in alignment with corporate goals. • Compilation and review of dossiers intended for US and Europe regions. • Preparation and timely submissions of responses to Regulatory authorities’ queries. • Preparation and review of Comparative threshold analysis and Design control/Design history files for drug/device combination product requirements as per 21CFR 820 for Prefilled syringes, Pen devices, Auto-Injectors, etc. • Review of Device functional and performance testing to support Regulatory submissions. • Reviews of change controls and technical/supportive information for submission to support various post approval activities. • Filing of post approval changes (Life-cycle management activities) to the US market. • Mentor/guide the team members to achieve their goals within the time constraints. • Evaluate and share knowledge throughout the group regarding the most recent Regulatory requirements.
• Planning and execution of robust Regulatory strategies for complex products such as Iron colloids and Peptide products. • Preparation and submission of Pre-ANDA meeting packages, Controlled correspondences for complex products to seek guidance/opinions/confirmations from the Regulatory Agencies. • Tracking the Regulatory filing plans to ensure timely, quality submissions and secure first review cycle approvals in alignment with corporate goals • Compilation and review of dossiers intended for US, Europe, and Canada regions. • Preparation and timely submissions of responses to Regulatory authorities. • Preparation and review of Comparative threshold analysis and Design control/Design history files for drug/device combination product requirements as per 21CFR 820 • Liaising with CMOs & CROs to update the current Regulatory requirements for effective and timely submissions. • Mentor/guide the team members to achieve their goals within the time constraints. • Evaluate and share knowledge throughout the group regarding the most recent Regulatory requirements.
• Preparation of robust Regulatory strategies for new drug developments of Injectable drug products including NDAs (505b2), ANDAs. • Preparation of Briefing book packages for injectable drugs and 505b2 formulations with the USFDA. • Dossier compilation and review of dossiers intended for the US, Europe, and Canada for sterile dosage forms. (Liquid injections, Lyophilized powders and PFS). • Preparation and timely submission of responses to Regulatory authorities. • Assessment and timely submission of post approval changes during the product lifecycle. • Regulatory Database Management (Product History Sheets/ Product Approval Notes/ Commitments Tracker/ Training tracker, etc.). • Review of site documents (BMRs, BPRs, process validation protocols and reports, STPs, Specifications, CoAs of Raw materials and finished products, stability protocols and stability data) required for ANDA/MAA filings. • Evaluate and share knowledge throughout the group regarding the most recent Regulatory requirements.
• Prepared Drug substance and Drug product dossiers as per the eCTD requirements and drug substance and drug product documents for post-approval changes as part of Global submissions. • Focused on technical congruency, regulatory compliance and collaborated with various departments across the globe for technical source documents in accordance with project timelines. • Authored multiple answer documents for the Health authority CMC questions. • Prepared Quality overall summaries and was involved in evaluating change requests. • Developed and maintained a strong communication network with global cross-functional teams, and coordinated the delivery of high-quality dossiers considering business priorities.