Infocus Remedies Pvt. Ltd., a group company of Saifen Drugs India Pvt. Ltd., is hiring a Regulatory Affairs (RA) Executive – Dossier Compilation for its manufacturing and regulatory operations at Naroda GIDC, Ahmedabad. This is an excellent opportunity for pharmacy professionals with hands-on experience in CTD/ACTD dossier compilation and regulatory documentation for domestic and international markets.
This full-time Regulatory Affairs job in Ahmedabad is ideal for candidates currently working in merchant pharmaceutical companies or regulatory service environments who want to strengthen their career in global regulatory submissions.
Job Details
- Position: RA Executive – Dossier Compilation
- Company: Infocus Remedies Pvt. Ltd.
- Group: Saifen Drugs India Pvt. Ltd.
- Location: Naroda GIDC, Ahmedabad, Gujarat
- Job Type: Full-time
- Work Mode: In-person
- Industry: Pharmaceutical / Regulatory Affairs
Key Responsibilities – Regulatory Affairs Executive
- Compile and review CTD & ACTD regulatory dossiers for new product registrations, renewals, and variations
- Ensure accuracy, consistency, and completeness of regulatory documents prior to submission
- Coordinate with QA, QC, R&D, Production, and Packaging teams to collect technical documents
- Maintain updated knowledge of country-specific regulatory requirements
- Prepare and submit responses to regulatory queries and deficiency letters within defined timelines
- Manage version control and lifecycle management of regulatory documents
- Assist in post-approval changes, amendments, renewals, and variations
- Resolve documentation gaps and regulatory deficiencies through internal coordination
- Support audits, inspections, and regulatory assessments
Qualifications Required
- Bachelor’s or Master’s degree in Pharmacy (B.Pharm / M.Pharm)
Experience Required
- 2–4 years of experience in Regulatory Affairs
- Strong preference for candidates with dossier compilation experience
- Candidates from merchant pharmaceutical companies will be preferred
Skills & Competencies
- Strong understanding of CTD / ACTD formats and global regulatory guidelines
- Excellent documentation, formatting, and proofreading skills
- Strong time management and coordination abilities
- High attention to detail and ability to work under strict regulatory timelines
Salary & Benefits
- Estimated Salary: ₹4,00,000 – ₹7,00,000 per annum (based on experience and skills)
- Exposure to international regulatory markets
- Career growth in a well-established pharmaceutical group
- Stable, full-time role with regulatory learning opportunities
How to Apply
Interested and eligible candidates can share their updated CV via email:
📧 Email: hr_india@saifendrugs.com
Mention “RA Executive – Dossier Compilation” in the subject line for faster processing.
