Pratheeksha Salian
Regulatory Affairs Executive @Aztec Pharma | Registered Pharmacist | Certified in Clinical Drug Development, Medical Writing, ICH GCP & QA
- Role
- Regulatory Affairs Executive at Aztec Pharma Private Limited
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Pratheeksha Salian
In my role as Regulatory Affairs Executive at Aztec Pharma, I focus on regulatory submissions, compliance management, and supporting product approvals for global markets.Passionate about Regulatory Affairs and Product Management, I enjoy solving compliance challenges and helping pharmaceutical products reach patients safely and efficiently.During my internships, I gained hands-on experience in Quality Assurance and Quality Control, focusing on documentation, data analysis, and process validation.I’m certified in Clinical Drug Development, Medical Writing, ICH GCP, and Pharmaceutical Quality Assurance, keeping me updated in the fast-evolving pharma industry.Let’s connect and transform healthcare together!
Experience
Regulatory Affairs Executive
Dec 2024 — Present · Mumbai, IN
Prepare and compile regulatory dossiers in CTD/ACTD formats for ASEAN and West African countries.Review technical documents (AMV, process validation, stability, DMFs, product development reports) for regulatory adequacy before submission.Manage artwork and labeling as per country-specific guidelines to ensure compliance for registration and commercial use.Manage dispatch of samples and legal documents for product registration/renewals and maintain proper documentation.Handle MOH queries and coordinate with cross-functional teams (QA, QC, Production) for dossier requirements.Liaise with licensing authorities for legal documents (WHO-GMP, COPP, Product Permission, FSC) and maintain dossier/registration records.Coordinate with manufacturers to gather administrative documents and product samples.
Education
Mithibai College of Arts Chauhan Institute of Science and A.J. College of Commerce and Economics
HSC, Science
Cardinal Gracias High School
SSC
Principal K. M. Kundnani College of Pharmacy
Bachelor's of Pharmacy
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