Orion Pharma, a globally operating pharmaceutical organization, is hiring an Officer โ Regulatory Affairs for its Mumbai Metropolitan Region office (Hybrid mode). This Regulatory Affairs Officer job in Mumbai is ideal for candidates with 2โ3 years of experience in regulatory affairs, product lifecycle management, and global submissions support.
If you are looking for a Regulatory Affairs job in Mumbai with exposure to EU requirements, ICH guidelines, and eCTD submissions, this opportunity offers strong career growth in a structured regulatory environment.
Job Overview
- Position: Officer โ Regulatory Affairs
- Company: Orion Pharma
- Location: Mumbai Metropolitan Region (Hybrid)
- Experience Required: 2โ3 years in regulated industry
- Qualification: Bachelorโs degree in Science
- Application Deadline: 27 February 2026
- Employment Type: Full-time
This Regulatory Affairs Officer role focuses on lifecycle management, regulatory compliance, and maintaining internal regulatory systems aligned with global standards.
Key Responsibilities โ Regulatory Affairs Officer
The selected candidate will:
- Manage Product Life Cycle Management (LCM) activities as per regulatory guidelines
- Ensure compliance with applicable regulatory requirements and internal SOPs
- Maintain and update Orionโs internal regulatory systems
- Keep regulatory archives updated with valid licenses and labelling documents
- Coordinate with internal and external stakeholders for change management
- Assist in electronic formatting of global regulatory submissions (eCTD)
- Support global filing documentation in line with agency guidance
- Perform administrative and documentation-related regulatory tasks
This Regulatory Affairs Officer job involves working with structured regulatory databases and supporting global filings in compliance with ICH and EU requirements.
Required Skills & Competencies
Essential Skills:
- 2โ3 years of experience in Regulatory Affairs or regulated pharmaceutical industry
- Knowledge of Product Lifecycle Management (PLM)
- Proficiency in MS Office (Word, Excel, PowerPoint, Outlook)
- Strong documentation and archival skills
- Ability to work independently and in cross-functional teams
- Fluency in English (written & verbal)
Preferred Skills:
- Knowledge of EU regulatory requirements
- Understanding of ICH guidelines
- Experience in eCTD submissions
- Familiarity with regulatory software systems
Candidates with hands-on experience in regulatory lifecycle management and electronic submissions will have an added advantage.
Qualification
- Bachelorโs Degree in Science from a reputed College/University
Why Join Orion Pharma?
Working as a Regulatory Affairs Officer at Orion Pharma offers:
- Opportunity to work with a wholly owned subsidiary of a global pharmaceutical group
- Exposure to international regulatory standards (EU & ICH)
- Flexible hybrid work environment
- Clear, transparent processes
- Professional supervision and structured workflows
- Strong work-life balance
This Regulatory Affairs job in Mumbai provides career progression opportunities in global regulatory operations.
How to Apply
Interested candidates should email their CV to:
๐ง recruitmentindia@orion.fi
Along with:
- Updated CV/Resume
- Current CTC
- Expected CTC
- Notice Period details
๐ Application Deadline: 27 February 2026
