A leading pharmaceutical organization has announced an excellent opportunity for experienced Regulatory Affairs professionals. Applications are invited for the position of Executive โ Regulatory Affairs at Ahmedabad, Gujarat. Candidates having strong knowledge of USFDA regulations, ANDA submissions, post-approval procedures, and CTD documentation are encouraged to apply.
This is a full-time opportunity for professionals looking to build their careers in pharmaceutical regulatory affairs while working with cross-functional teams on global regulatory submissions.
Job Overview
Position Name: Executive โ Regulatory Affairs
Location: Ahmedabad, Gujarat, India
Department: Regulatory Affairs
Employment Type: Full-Time
Experience Required: 5โ8 Years
Qualification: B.Pharm (Required), M.Pharm (Preferred)
Application Last Date: 30 June 2026
Key Responsibilities
The selected candidate will be responsible for:
- Handling ANDA submission activities and post-approval regulatory procedures.
- Reviewing change cases as per ICH Quality Guidelines and USFDA requirements.
- Preparing Annual Reports with required submission data.
- Supporting CBE-0, CBE-30, PAS and Annual Report submissions.
- Performing preliminary review of regulatory submission packages.
- Coordinating with cross-functional departments to collect submission documents.
- Ensuring timely preparation and compilation of regulatory dossiers.
- Maintaining regulatory information and documentation.
- Drafting and reviewing CTD modules.
- Monitoring regulatory compliance and commercial marketing status notifications.
Required Qualifications
Candidates should possess:
- B.Pharm (Mandatory)
- M.Pharm (Preferred)
Experience Required
- Minimum: 5 Years
- Preferred Experience: 5โ8 Years in Pharmaceutical Regulatory Affairs.
Required Skills
- Regulatory Compliance
- Regulatory Filings
- Regulatory Reporting & Documentation
- ANDA Submission Knowledge
- USFDA Guidelines
- ICH Guidelines
- CTD Module Drafting
- Documentation & Record Control
- Cross-functional Collaboration
- Analytical Thinking & Problem Solving
- Effective Communication
- Data Governance & Compliance
Salary & Benefits
Expected Salary: โน8,00,000 โ โน12,00,000 per annum (Estimated based on industry standards and experience.)
Benefits may include:
- Competitive salary package
- Career growth opportunities
- Professional learning environment
- Exposure to global regulatory projects
- Employee benefits as per company policy