Nik Nik

Clinical Research and Regulatory Affairs professional with 2+ years of pharmaceutical industry experience in regulatory documentation, global submissions, compliance management, and cross-functional coordination. Certified in Clinical Research with knowledge of GCP, ICH guidelines, clinical trial processes, regulatory documentation, clinical data management, and adverse event reporting. Experienced collaborating with R&D, QA, QC, and manufacturing teams in regulated pharmaceutical environments.

Skilled in documentation review, regulatory compliance, and scientific data handling. Seeking opportunities as a Clinical Research Coordinator, Clinical Research Associate, or Regulatory Operations professional.

Junior Executive – Regulatory Affairs - Lee Pharma Limited

(2023-04 - 2025-09)

• Prepared and compiled CTD and ACTD dossiers for regulatory submissions across Saudi Arabia, South Africa, Canada, LATAM, EU, and ROW markets.
• Coordinated cross-functional teams including R&D, QA, QC, and manufacturing for preparation and compliance of pharmaceutical documentation.
• Maintained accurate regulatory documentation aligned with ICH and international regulatory standards.
• Conducted regulatory gap analysis to ensure submission readiness and compliance before filings
• Reviewed process validation reports, batch manufacturing records, and product specifications in regulated pharmaceutical environments.
• Reviewed packaging artwork and labeling documentation for regulatory compliance.
• Prepared responses to regulatory queries, deficiencies, and client documentation requests.
• Supported lifecycle management activities and scientific documentation review for regulated pharmaceutical products.
• Worked within quality-driven environments requiring high attention to detail, documentation accuracy, and compliance.

M.Pharm - Pharmaceutical Drug Regulatory Affairs - Andhra University

B.Pharm - Vignan Institute of Pharmaceutical Technology