Regulatory Affairs Officer

Roles & Responsibilities:
• Manage Product Life Cycle Management (LCM) activities in line with regulatory guidelines
• Ensure compliance with applicable regulatory requirements and internal SOPs
• Maintain and update internal regulatory databases and tracking systems
• Keep regulatory archives updated with valid licenses, approvals, and labelling documents
• Coordinate with internal and external stakeholders for change management activities
• Assist in electronic formatting and compilation of global regulatory submissions (eCTD)
• Support preparation and review of global filing documentation as per agency guidance
• Perform documentation control, archival, and administrative regulatory tasks
• Support regulatory submissions in compliance with ICH and EU requirements

Qualification:
• Bachelor degree in Pharmacy, Master of Pharmacy
• Bachelor’s Degree in Science from a reputed College/University

Experience:
• 2–3 years of experience in Regulatory Affairs or regulated pharmaceutical industry

Skills:
• Knowledge of Product Lifecycle Management (PLM)
• Understanding of EU regulatory requirements and ICH guidelines
• Experience in eCTD submissions and electronic publishing
• Proficiency in MS Office (Word, Excel, PowerPoint, Outlook)
• Strong documentation, tracking, and archival skills
• Familiarity with regulatory software systems
• Ability to work independently and collaboratively in cross-functional teams
• Fluency in English (written and verbal communication)

About the Organization:
Orion Pharma is a globally operating pharmaceutical organization focused on delivering innovative and high-quality medicines while maintaining strong regulatory compliance across international markets.