Yaseen Irfan

A competent professional with nearly 9+ years of learning experience in Regulatory Affairs in Pharmaceutical sector. My role involves authoring, compilation and submission of high-quality CTD dossiers for new applications, post approval changes (Variations), Annual reports, Renewals. Proven abilities in managing final product submission / registration & negotiating with regulatory authorities to obtain approvals.

Deft in dealing with Product Teams about implementation of regulatory requirements. Strong background in providing responses to regulatory agencies regarding product information or issues. Keen communicator with honed problem solving and analytical abilities.

Regulatory Affairs Consultant - Parexel International - Bengaluru, India

(2026-07)

Senior Regulatory Affairs Associate - Parexel International - Bengaluru, India

(2022-04)

Regulatory Affairs Associate - Parexel International - Bengaluru, India

(2019-08 - 2022-03)

• Authoring of variation package for global markets (EU, US, AUS, NZ, Canada) for multiple dosage forms.
• Compilation and submission of high-quality CTD dossiers for new applications, post approval changes (Variations), Annual reports, Renewals.
• Response to the queries to the health authority within given time frame.
• Annual report submissions for the impacted markets based on assessment.
• Coordination with relevant cross functional team for the documents/information required for the dossier.
• Change control assessment for global markets.
• Experience of handling Veeva Vault (RIM), CARA, Verity, Infinity, Track wise, CSI portal etc. efficiently.
• Working on monthly verity compliance reports.
• Coordinating with stake holders like Product responsible, SME, local affiliates and manufacturing sites to ensure submission packages are complete and ready for submission.
• Provide trainings to new employees.
• Preparation of QC checklists

Regulatory Affairs Officer - Relicare Tech Services Private Limited (Adcock Ingram Company) - Bengaluru, India

(2016-11 - 2019-08)

• Ensure compilation and preparation of a high quality CTD dossier as per specific country requirement.
• Coordinate with R&D, QA, QC & production for documents.
• Compile dossiers for pre & post approval variations.
• Review of DMF/CEP and all other relevant documentation according to SAHPRA/specific country requirements.
• To prepare Module 1, 2 and 3 as in e CTD /NeeS as per specific country requirements (South Africa, Kenya, Botswana, Tanzania, Zambia, Uganda, Rwanda, Ethopia, Ghana, Malawi, Mozambique and Zimbabwe).
• Brief hand on experience in docu-bridge for e-filing.
• Hyperlink and upload the dossier in eCTD software (docu-bridge).

Master of Pharmacy - Pharmaceutics - Al-Ameen college of pharmacy (2016)

Bachelor of Pharmacy - Al-Ameen college of pharmacy (2014)

Pre-university - Byraveshwara rural PU college (2010)

SSLC - St. Anne's High School (2008)