Regulatory Affairs Officer - CTD Dossier & Pharmaceutical Submissions

Why This Role Matters
The Regulatory Affairs Officer plays a key role in ensuring pharmaceutical products comply with international regulatory standards before market approval. This position supports the preparation and submission of regulatory dossiers, coordinates documentation across departments, and ensures products meet regulatory requirements in global markets.

Job Description
The Regulatory Affairs Officer will be responsible for preparing CTD dossiers for international markets, compiling regulatory documentation, and coordinating with cross-functional teams for regulatory submissions. The role involves ensuring regulatory compliance, supporting documentation preparation, and responding to regulatory queries from authorities.

Key Features of the Role
• Opportunity to work in pharmaceutical regulatory affairs and global submissions
• Exposure to regulatory processes for LATAM and ROW markets
• Experience in CTD dossier preparation and documentation management
• Collaboration with cross-functional teams including quality, manufacturing, and regulatory departments
• Career growth opportunities within pharmaceutical regulatory affairs

Responsibilities
• Prepare CTD dossiers for regulatory submissions in LATAM and ROW markets
• Compile regulatory documentation and technical data into CTD format
• Ensure timely preparation and submission of regulatory dossiers
• Coordinate with cross-functional teams for document collection and regulatory documentation
• Review and finalize dossiers before submission to regulatory authorities
• Handle post-submission regulatory queries from health authorities
• Perform artwork review before regulatory submission
• Prepare Summary of Product Characteristics (SmPC) and package inserts
• Maintain regulatory documentation and submission records

Required Qualifications

Educational Requirements
• Bachelor of Pharmacy (B.Pharm) – Required
• Master of Pharmacy (M.Pharm) – Preferred

Experience and Skills
• Experience in Regulatory Affairs within the pharmaceutical industry
• Experience in oral solid dosage (OSD) formulations preferred
• Knowledge of CTD dossier preparation and regulatory submission processes
• Strong documentation and regulatory compliance skills
• Ability to coordinate with multiple departments for regulatory documentation
• Good communication and organisational skills

Key Skills
• CTD dossier preparation
• Pharmaceutical regulatory submissions
• Regulatory documentation management
• Artwork and labeling review
• SmPC and package insert preparation
• Cross-functional coordination and regulatory compliance

Company Overview
Octavius Pharma Pvt. Ltd. is a pharmaceutical manufacturing company involved in the development and marketing of a wide range of healthcare products including tablets, capsules, injectables, nutraceuticals, herbal products, and cosmetic formulations. The company also provides services such as formulation development, technology transfer, dossier preparation, and third-party manufacturing while exporting pharmaceutical products and bulk drugs to international markets.

FAQs
• What qualifications are required for this role?
Candidates must have a B.Pharm degree. M.Pharm is preferred but not mandatory.

• What regulatory experience is preferred?
Experience in CTD dossier preparation and pharmaceutical regulatory documentation is preferred.

• Which markets will the role support?
The role primarily supports regulatory submissions for LATAM and ROW markets.

• Is experience in specific formulations required?
Experience in oral solid dosage formulations is preferred.

Application Tips
• Highlight CTD dossier preparation experience in your resume
• Mention regulatory submission experience for international markets if applicable
• Include experience with regulatory documentation and artwork review
• Emphasise cross-functional coordination with quality and manufacturing teams
• Keep regulatory documentation experience clearly structured in your CV