BHARATH CHANDRA KOKKULA
Auckland,New Zealand
Summary
Accomplished professional with expertise in GMP compliance, regulatory submissions, and pharmacovigilance. Demonstrates proficiency in technical writing, health policy, and lifecycle management, ensuring adherence to quality assurance standards and risk management protocols. Skilled in cross-functional team collaboration and regulatory intelligence, with a proven track record in post-market surveillance, audit preparation, and reporting. Adept at managing regulatory documentation, product labelling, and promotional material compliance to support strategic objectives. Committed to driving excellence in regulatory strategy development while maintaining compliance across all operational facets.
Overview
1
1
Certification
4
4
years of post-secondary education
9
9
years of professional experience
Work history
Regulatory Affairs Executive
Cronus Pharmaceutical Company
Shamshabad, India
2023.07 - 2026.08
- Managed regulatory submissions for new product approvals, renewals, and variations, streamlining dossier preparations to enhance approval timelines.
- Developed regulatory strategies for product development, ensuring efficient and successful market entry in US region.
- Ensured compliance with regulatory requirements for US market, including FDA, EMA, and other regulatory bodies.
- Oversaw preparation and submission of product registration dossiers globally, ensuring compliance with regulatory standards. to ensure strict compliance.
- Monitored and assessed changes in regulatory frameworks, providing timely updates and guidance to internal teams.
- Maintained accurate, compliant regulatory documentation.
- Evaluated labelling artwork for compliance with safety standards and regulations. to ensure adherence to current safety standards.
Regulatory Affairs Officer
Hetero Pharmaceutical Company
Jeedimetla, India
2020.09 - 2022.11
- Prepared and submitted regulatory applications and responses to inquiries from regulatory authorities, facilitating compliance and approval processes.
- Supported development of strategies for timely product approvals, enhancing regulatory pathway efficiency.
- Maintained regulatory documentation to ensure compliance with industry and regulatory standards, safeguarding product integrity.
- Kept up to date with global regulatory requirements, implementing necessary product development process changes.
- Collaborated with cross-functional teams to ensure that regulatory requirements were met throughout product development.
- Assisted with post-market surveillance, monitoring product performance and ensuring compliance with regulatory requirements.
Internship trainer
Rashmi pharmaceutical industry
Hyderabad, India
2018.01 - 2019.01
- Monitored industry operations and regulatory processes to gain insights into best practices and compliance standards.
- Adapting teaching strategies according to individual learning styles resulted in better comprehension.
- Kept abreast of latest industry trends, ensuring relevance and applicability of course content.
- Effectively addressed queries and concerns from interns, fostering positive learning experience.
Education
Doctor of Philosophy - Pharmacy
University of Auckland
New Zealand 2026.09 -
Master Diploma - Business Management
IIET-Integrated Institute of Education and Training Centre
Hyderabad, Telangana, India 2020.11 - 2022.11
PG Certificate - Applied Public Health
University of Central Lancashire
Preston, UK 2019.09 - 2020.05
Master of Pharmacy - Pharmaceutics
JNTUH
Hyderabad, Telangana, IndiaBachelor of Pharmacy - Pharmacy
Osmania University
Hyderabad, Telangana, IndiaOne-Year Diploma - Health and Safety Environment
Integrated Institute of Education Technology (IIET)
Hyderabad, Telangana, India 2017.06 - 2018.05
Skills
GMP Compliance
Technical Writing
Health Policy
Lifecycle management
Quality Assurance
Risk Management
Pharmacovigilance
ECTD Submissions
Regulatory Submissions and filings
Cross-functional Team Collaboration
Risk Management, Regulatory Intelligence, and Strategy Development
Post-Market Surveillance, Audit Preparation and Reporting
Regulatory Documentation, Product Labeling and Promotional Material Compliance
Certification
- Pearson Test Of English-58 (Equivalent to 6.5 in IELTS)
Languages
Telugu
Hindi
English
Publications and Research Experience
- Master’s Thesis: Preparation and Evaluation of Self-Emulsifying Drug Delivery System of Carvedilol
- Publication (Peer-Reviewed): Community Pharmacists and Their Role in Non-Communicable Disease (NCD) Management: A Critical Review of Global and Indian Evidence
- Indian Journal of Pharmacy Practice, Vol. 19(2), https://ijopp.org/10.5530/ijopp.20260501 (DOI:10.5530/ijopp.20260501)
Research Interest
- Healthcare regulatory systems
- Pharmaceutical operations management
- Public health policy and workforce integration
- Strategic compliance in healthcare organizations
Accomplishments
Employee of the Month – Cronus Pharma
References
References available upon request.
Timeline
Doctor of Philosophy - Pharmacy
University of Auckland
2026.09 -
Regulatory Affairs Executive
Cronus Pharmaceutical Company
2023.07 - 2026.08
Master Diploma - Business Management
IIET-Integrated Institute of Education and Training Centre
2020.11 - 2022.11
Regulatory Affairs Officer
Hetero Pharmaceutical Company
2020.09 - 2022.11
PG Certificate - Applied Public Health
University of Central Lancashire
2019.09 - 2020.05
Internship trainer
Rashmi pharmaceutical industry
2018.01 - 2019.01
One-Year Diploma - Health and Safety Environment
Integrated Institute of Education Technology (IIET)
2017.06 - 2018.05
Bachelor of Pharmacy - Pharmacy
Osmania University
Master of Pharmacy - Pharmaceutics
JNTUH