Bhanu Katarapu

Regulatory Affairs professional with 5+ years of experience in pharmaceuticals, nutraceuticals, probiotics, and dietary supplements. Experienced in regulatory submissions, CTD/ACTD dossier preparation, global regulatory compliance, and product registration for domestic and international markets. Hands-on experience with regulatory submissions and interactions with ANVISA (Brazil), COFEPRIS (Mexico), INVIMA (Colombia), LATAM countries, Africa, Middle East, and CIS regions.

Strong knowledge of ICH guidelines, labeling compliance, regulatory documentation, and product lifecycle management. Certified ISO 9001:2015 Internal Auditor with knowledge of Quality Management Systems (QMS), GMP compliance, and internal audits.

Senior Executive – Regulatory Affairs, Team Leader – Regulatory Department at Lactonova Nutripharm Pvt Ltd. (2023-03 – Present)

Leading a Regulatory Affairs team of 5 members. Responsible for end-to-end regulatory activities for domestic and export markets.

• Leading a Regulatory Affairs team of 5 members
• Responsible for end-to-end regulatory activities for domestic and export markets
• Preparation and review of product dossiers, regulatory documentation, and artwork compliance
• Handling FSSAI licenses, DGFT licenses, and Certificates of Origin
• Providing technical clarifications and regulatory query responses
• Supporting new formulation development and RDA value assessments
• Recruiting, training, and mentoring new team members

Regulatory Affairs Senior Executive at Botanic Health care Pvt Ltd. (2022-08 – 2023-02)

Managed regulatory affairs and compliance for nutraceutical products

• Managed FSSAI licensing and regulatory documentation
• Developed and reviewed product artwork and labeling compliance
• Worked closely with Business Development teams for product registration and plant approvals
• Supported regulatory strategy for nutraceutical products

Regulatory Affairs- Jr.Executive at Elmed Life Sciences Pvt. Ltd (2021-12 – 2022-07)

Prepared and compiled regulatory dossiers for international markets with focus on Latin America

• Prepared and compiled CTD, ACTD, and ROW dossiers based on regulatory guidelines
• Handled queries from MOH and international regulatory authorities
• Ensured compliance for nutraceutical and probiotic products for ANVISA (Brazil), COFEPRIS (Mexico), INVIMA (Colombia), and LATAM countries
• Coordinated with internal departments to collect regulatory documentation
• Managed FSSAI license modifications and regulatory queries
• Supported DGFT applications for Free Sale Certificates (FSC)
• Reviewed artwork, SPC, labeling, and Patient Information Leaflets (PIL)
• Maintained and updated product registration databases

Regulatory Affairs- Technical officer at VH Foods Pvt. Ltd (2020-01 – 2021-10)

Prepared pharmaceutical regulatory dossiers for domestic and international markets

• Prepared pharmaceutical regulatory dossiers for domestic and international markets
• Worked with ICH Quality guidelines and CTD format documentation
• Coordinated with R&D, QA, QC, Production, and Packaging teams for regulatory submissions
• Reviewed technical documentation, analytical data, MOA, COA, and stability reports
• Ensured compliance with IP, USP, and BP pharmacopeia standards
• Maintained cGMP regulatory compliance documentation

Regulatory Affairs- Jr. Technical officer at Cheminor Life Sciences (2019-03 – 2019-12)

Junior technical officer responsibilities in regulatory affairs

• Review of COAs, MOAs and Stability Data
• Review of documents including BMR's, BPR's, API/Raw Material/Packing Material/Finished Product Specifications, STP's, PDR, AMV, data
• Reaction setting, Work ups
• Dry and purify samples for downstream applications
• Preparation of Invoice and Purchase Order

M.Pharmacy in Pharmaceutics – St. Mary's College of Pharmacy (2019)

B.Pharmacy in Pharmacy – Montessori Siva Sivani Institute of Science and Technology College of Pharmacy (2017)