Open to opportunities

BALASUBRAMANYA P K

@balasubramanyapk

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Passionate Regulatory Affairs professional with expertise in global submissions.

India

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What I'm looking for

I am looking for a role that fosters innovation and offers growth opportunities in regulatory affairs and clinical research.

I am a dedicated Regulatory Affairs professional with a Master's degree in Pharmacy, specializing in global regulatory submissions and compliance. My hands-on experience includes working with regulatory frameworks such as SFDA, NHRA, and MOH, where I have successfully coordinated with cross-functional teams to ensure timely and compliant documentation. I am committed to aligning regulatory strategies with global standards to support innovation and improve patient access to quality healthcare solutions.

Throughout my career, I have developed a strong foundation in clinical research and pharmacovigilance, allowing me to respond effectively to customer and regulatory agency queries. My experience at Macleods Pharmaceuticals and Strides Pharma Science has equipped me with the skills necessary to handle regulatory submissions, variations, and documentation with accuracy and efficiency. I am eager to contribute to the successful development, registration, and lifecycle management of pharmaceutical products.

Experience

Work history, roles, and key accomplishments

Current

Junior Officer – Global Regulatory Affairs

Current

Macleods Pharmaceuticals Limited

Jan 2025 - Present (6 months)

Currently serving as a Junior Officer in Global Regulatory Affairs, contributing to global regulatory submissions and ensuring compliance with international frameworks. Responsible for coordinating with cross-functional teams to deliver accurate documentation and support timely approvals for pharmaceutical products.

Regulatory Affairs Regulatory Submissions NHRA MOH QA R&D Regulatory Compliance

Associate – Global Regulatory Affairs

Macleods Pharmaceuticals Limited

Jul 2024 - Dec 2024 (5 months)

Served as an Associate in Global Regulatory Affairs, focusing on handling regulatory submissions, variations, and coordinating with internal teams. Ensured accurate documentation and supported timely approvals for pharmaceutical products.

Regulatory Affairs Regulatory Submissions CDSCO CTD

Intern – Global Regulatory Affairs

Strides Pharma Science Limited

Aug 2023 - Feb 2024 (6 months)

Completed an internship in Global Regulatory Affairs, gaining hands-on experience in regulatory frameworks and documentation. Assisted in preparing high-quality regulatory submission documents and ensuring compliance with ICH regulatory standards.

Regulatory Affairs Regulatory Regulatory Compliance

Intern – Research and Development

Steer life Pvt ltd

Dec 2021 - Jan 2022 (1 month)

Undertook an internship in Research and Development, focusing on drug discovery and pre-clinical research. Gained foundational knowledge in clinical research and pharmacovigilance.

research and development Drug Discovery Clinical Research Pharmacovigilance

Education

Degrees, certifications, and relevant coursework

JSS College of Pharmacy, JSS AHER

PG Diploma, Clinical Research

2023 - 2024

Grade: 76.77%

Obtained a Post Graduate Diploma in Clinical Research with a percentage of 76.77. Gained a strong foundation in clinical research, including drug discovery, pre-clinical research, clinical trials, and ethical guidelines.

JSS College of Pharmacy, JSS AHER

Bachelor of Pharmacy, Pharmacy

2019 - 2022

Grade: 7.71 CGPA

Completed a Bachelor of Pharmacy degree with a CGPA of 7.71. Developed foundational knowledge in pharmaceutical sciences, preparing for advanced studies and professional practice.

JSS College of Pharmacy, JSS AHER

Diploma in Pharmacy, Pharmacy

2017 - 2019

Grade: 66.2%

Earned a Diploma in Pharmacy with a percentage of 66.2. Acquired essential skills and knowledge in pharmaceutical dispensing and basic drug information.