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Sam k

@samk5

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Entry-level Regulatory Affairs candidate familiar with CTD/eCTD submissions, ICH guidelines, and CDSCO requirements.

India

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What I'm looking for

I’m seeking an entry-level Regulatory Affairs role where I can support regulatory submissions and ensure compliance.

My Pharm.D training gave me a foundation in clinical pharmacy, pharmacology, and drug safety. I’m seeking an entry-level Regulatory Affairs role where I can support submissions and compliance.

During my one-year internship at RIMS, I assisted healthcare professionals with routine patient care, assessment, and monitoring. I also maintained patient records and documented clinical information.

On my project, “Barriers Hindering Chronic Disease Management in a Tertiary Care Hospital,” I conducted a patient-based survey with 100+ participants. I analyzed treatment adherence patterns and recommended strategies projected to improve adherence.

I’m familiar with CTD/eCTD dossier structure, ICH guidelines, CDSCO requirements, and the drug approval process. My preparation also includes regulatory documentation, scientific writing, pharmacovigilance basics, and quality and compliance practices.

Experience

Work history, roles, and key accomplishments

Hospital Internship

RIMS

Jun 2025 - May 2026 (11 months)

Completed a one-year internship with practical exposure to hospital operations and patient care. Assisted healthcare professionals in routine patient care, assessment, and monitoring, and maintained patient records.

Patient Care Clinical Documentation Communication Skills Interpersonal Skills Infection Control Multidisciplinary Collaboration