Drug Regulatory Affairs Manager

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 (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.