Drug Regulatory Affairs Executive

Job Description

Job description Having technical knowledge/ experience in dossier compilation (CTD ACTD) for European, CIS, ASEAN countries. Awareness of regulatory guidelines (EU) & Pharmacopoeia. Controlling the whole process of registration product from beginning till the end. Evaluation of Bioequivalence. Having knowledge of ICH guideline. To be flexible for travelling and meeting with manufacturing plant representatives, which located out station (if required)? Must have excellent communication skills Must have excellent in analyzing skills Excellent in accuracy and focus Self-motivated and enthusiastic Roles and Responsibilities Dossier Compilation & Review of both Finished Product and API (CTD, eCTD, ACTD) and reply of Subsequent Queries Independently. Maintained & update the regulatory documents /records. Follow up from plant R&D Team for AMD, AMV, Tech Transfer, Stability Charging Date, AMV timeline Preparation of all technical document of dossier like package inserts, rationale, drug-drug interaction. Review of artwork for submission. Prepare CTD, ACTD Dossiers and file regulatory submissions. Perform assessments of new or revised products. Manage complaint documentation (including investigation and closure). Respond to inquiries from regulatory bodies. Should be technically well versed with requirements for medicines with fare knowledge about medicines, food supplement. To coordinate with relevant department for arranging documents. To prepare / compile dossier for allocated products / countries. To coordinate with courier agency for dispatches of dossier /samples. To make timely entries of submissions / dispatches. Excellent communication skills. Should be aware about Microsoft office [word / Excel/ PPT] - Good in data management. Should be well versed in the process of Contract Drafting. Hands on experience and knowledge for drafting Non-Disclosure Agreements. Help the company for resolve the regulatory matters.