GOKULA KRISHNAN. K
Executive - Regulatory Affairs
Chennai
Summary
As a dedicated and Detail-oriented Regulatory Affairs professional with knowledge of pharmaceutical regulations, dossier preparation, and compliance requirements. Skilled in coordinating with cross-functional teams to support product registration and regulatory submissions. Strong communication, documentation, and problem-solving abilities with a focus on quality and accuracy.
Overview
6
6
years of professional experience
1
1
Certification
2
2
Languages
Work History
Drug Regulatory Affairs Executive
Steril Gene Life Sciences
Chennai, Tamilnadu
09.2022 - Current
- Prepared and submitted regulatory dossiers for pharmaceutical products in accordance with country-specific requirements.
- Compiled CTD submissions including Modules 1–5.
- Coordinated with QA, QC, Manufacturing, R&D, and Supply Chain departments for regulatory documentation.
- Managed variations, renewals, amendments, and product registrations.
- Handling of Tenders and Direct orders for various countries
- Reviewed product labeling, artwork, and packaging materials for regulatory compliance.
- Tracked submission timelines and maintained regulatory databases.
- Responded to health authority queries and Customer based queries
- Ensured compliance with national and international pharmaceutical regulations.
Executive
Maiva pharma private limited
Hosur, Tamilnadu
06.2020 - 09.2022
- Conducted analysis of primary packaging materials (rubber stopper, vials, seals, ampoules) and finished products, handled UV, IR, AAS instruments, autotitrator, and penetrability tester, and prepared COA for packaging materials and finished products while managing QMS processes (OOS, lab incidents, change controls)
Education
M.Sc - Chemistry
National College
Tiruchirappalli04-2020
B.Sc - Chemistry
Bishop Heber College
Tiruchirappalli04-2018
Skills
- Regulatory Affairs, CTD/ACTD Submissions, Product Registration, Regulatory Compliance, Dossier Compilation, Lifecycle Management, Documentation review, GMP, ICH Guidelines, US FDA Regulations, Labeling Review, Change Control, Regulatory Documentation, Microsoft Office, Cross-functional Coordination, Risk Assessment
Certification
Post Graduate Diploma in Analytical Techniques
Timeline
Drug Regulatory Affairs Executive
Steril Gene Life Sciences
09.2022 - Current
Executive
Maiva pharma private limited
06.2020 - 09.2022
B.Sc - Chemistry
Bishop Heber College
M.Sc - Chemistry
National College