Ciron Drugs & Pharmaceuticals is hiring Regulatory Affairs professionals for Officer to Executive roles at its Goregaon, Mumbai location. Candidates with 1–6 years of experience in pharmaceutical regulatory affairs, CTD/eCTD dossier preparation, regulatory submissions, and global registration activities can apply for this opportunity.
This Regulatory Affairs job opening is ideal for B.Pharm and M.Pharm professionals looking to build their careers in pharmaceutical regulatory submissions, dossier management, compliance, and international market registrations.
Job Details
- Company: Ciron Drugs & Pharmaceuticals
- Job Role: Regulatory Affairs Officer to Executive
- Experience Required: 1–6 Years
- Location: Goregaon, Mumbai Suburban, Maharashtra
- Employment Type: Full-Time, Permanent
- Industry: Pharmaceutical & Life Sciences
- Openings: 9
Key Responsibilities of Regulatory Affairs Officer
Selected candidates will be responsible for managing regulatory documentation, submission activities, and compliance requirements, including:
- Preparation and submission of registration dossiers in CTD, ACTD, and country-specific formats.
- Compilation and review of regulatory documents according to ICH and country-specific guidelines.
- Coordination with Plant, R&D, CQA, and ADL departments for technical document accuracy.
- Ensuring regulatory submissions meet quality standards and timelines.
- Reviewing quality documents including:
- Raw Material and Finished Product specifications
- Standard Testing Procedures (STP)
- Stability protocols and reports
- Process validation protocols and reports
- Analytical method validation documents
- Supporting regulatory submissions for international markets.
- Preparing responses to regulatory authority queries.
- Reviewing and approving product artworks according to country requirements.
- Coordinating samples, working standards, and artwork submissions.
- Following up with regulatory agents regarding registration progress.
- Maintaining regulatory submission records and registration databases.
- Tracking country-wise registration status and renewal activities.
- Supporting tender submissions with required technical documents.
Eligibility Criteria for Regulatory Affairs Jobs
Candidates applying for this pharmaceutical regulatory affairs role should have:
- 1–6 years of experience in Regulatory Affairs within the pharmaceutical industry.
- Bachelor’s degree in Pharmacy (B.Pharm) or Master’s degree in Pharmacy (M.Pharm).
- Strong understanding of:
- CTD dossier preparation
- eCTD submissions
- Regulatory documentation
- Pharmaceutical registration processes
- Regulatory compliance requirements
Skills Required
Key skills preferred for this Regulatory Affairs Officer vacancy:
- Regulatory Affairs
- Drug Regulatory Affairs
- CTD and eCTD Documentation
- Dossier Preparation
- Pharmaceutical Regulatory Submissions
- International Market Registration
- Regulatory Compliance
- Submission Tracking
Why Apply for This Regulatory Affairs Career Opportunity?
Working as a Regulatory Affairs Officer or Executive provides professionals with exposure to:
- Global pharmaceutical registration processes.
- Regulatory submission lifecycle management.
- Cross-functional collaboration with R&D, Quality, and Manufacturing teams.
- Career growth opportunities in pharmaceutical regulatory affairs.
- Experience with CTD, eCTD, and international regulatory requirements.
How to Apply
