Ciron Drugs & Pharmaceuticals is inviting applications for the position of Regulatory Affairs Officer to Executive at its Goregaon, Mumbai office. This is an excellent opportunity for B.Pharm and M.Pharm graduates with 1 to 6 years of Regulatory Affairs experience to build their careers in international pharmaceutical regulatory submissions, CTD/eCTD dossier preparation, and global market registrations.
Candidates with expertise in CTD, eCTD, regulatory submissions, dossier preparation, and pharmaceutical documentation are encouraged to apply.
Job Highlights
- Company: Ciron Drugs & Pharmaceuticals
- Job Role: Regulatory Affairs Officer to Executive
- Department: Regulatory Affairs
- Job Type: Full-Time, Permanent
- Experience: 1–6 Years
- Qualification: B.Pharm / M.Pharm
- Location: Goregaon, Mumbai
- Openings: 9
Key Responsibilities
Selected candidates will be responsible for:
- Preparing and submitting regulatory dossiers in CTD, eCTD, ACTD, and country-specific formats
- Coordinating with Plant, R&D, CQA, and ADL teams for technical documentation
- Reviewing regulatory documents as per ICH guidelines and country-specific requirements
- Compiling and reviewing quality documents including:
- Raw Material & Finished Product Specifications
- STP (Standard Testing Procedures)
- Stability Protocols & Reports
- Process Validation Protocols
- Analytical Method Validation Documents
- Supporting product registration activities for international markets
- Preparing responses to regulatory authority queries
- Reviewing and approving packaging artworks according to country regulations
- Managing regulatory samples, working standards, and submission records
- Tracking product registration status and renewals
- Supporting tender submissions with technical documentation
Eligibility Criteria
Applicants should have:
- B.Pharm or M.Pharm qualification
- 1–6 years of experience exclusively in Regulatory Affairs
- Strong knowledge of:
- CTD & eCTD
- Dossier Preparation
- Regulatory Submissions
- International Regulatory Guidelines
- Pharmaceutical Documentation
- Regulatory Compliance
Preferred Skills
- Regulatory Affairs
- CTD & eCTD Submission
- Drug Regulatory Affairs
- Dossier Compilation
- ROW Market Registrations
- Regulatory Documentation
- ICH Guidelines
- Submission Tracking
- Pharmaceutical Compliance
- International Regulatory Affairs
Why Join Ciron Drugs & Pharmaceuticals?
Working with Ciron offers professionals an opportunity to:
- Build expertise in global regulatory affairs
- Gain exposure to international pharmaceutical markets
- Work on CTD and eCTD submissions
- Collaborate with experienced R&D and Quality teams
- Enjoy long-term career growth in Regulatory Affairs
- Be part of a rapidly growing pharmaceutical organization
Job Location
Goregaon (East), Mumbai, Maharashtra