Zuche Pharmaceuticals is currently hiring Executive / Sr Executive – Regulatory Affairs professionals to strengthen its regulatory compliance and medical device documentation team. This opportunity is ideal for B.Pharm or M.Pharm graduates with regulatory affairs experience in medical devices, particularly those familiar with USFDA and ICH regulatory guidelines.
The role involves preparing Technical Case Files (TCF), regulatory documentation, artworks, and participating in clinical evaluation and post-market surveillance activities. Candidates with experience in regulatory submissions, validation documentation, and quality audits will find this role highly suitable.
This Regulatory Affairs job in the pharmaceutical and medical device sector offers hands-on exposure to regulatory compliance, documentation management, and quality systems aligned with global standards.
Key Responsibilities
The Executive / Sr Executive Regulatory Affairs professional will be responsible for:
- Preparing, compiling, and reviewing Technical Case Files (TCF) for medical devices
- Ensuring compliance with USFDA, ICH guidelines, and regulatory standards
- Reviewing and preparing artworks and labeling documentation for medical devices
- Supporting clinical evaluation and post-market surveillance (PMS) activities
- Participating in post-market clinical follow-ups (PMCF)
- Reviewing regulatory technical documents including:
- Process Validation Protocols (PVP) and Reports (PVR)
- Specifications (SPEC) and Standard Testing Procedures (STP)
- Certificates of Analysis (COA)
- Stability study reports
- Batch Manufacturing Records (BMR) and Master Formula Records (MFR)
- Preparing and maintaining Standard Operating Procedures (SOPs)
- Supporting internal and external regulatory audits
- Performing regulatory documentation tasks assigned by the Head of Department (HOD)
Qualifications
Candidates applying for this Regulatory Affairs Executive job in the pharmaceutical industry should meet the following criteria:
Education
- B.Pharm (Bachelor of Pharmacy) or
- M.Pharm (Master of Pharmacy)
Experience
- 0 – 5 years of experience in Regulatory Affairs
- Experience with medical device regulatory documentation preferred
- Understanding of USFDA regulations and ICH guidelines
Required Skills
- Regulatory Affairs documentation
- Medical device regulatory compliance
- Technical Case File (TCF) preparation
- Regulatory submissions and documentation review
- SOP preparation and documentation management
- Knowledge of ICH guidelines and USFDA requirements
- Audit support and regulatory compliance monitoring
Salary & Benefits
- Estimated Salary: ₹2.5 – ₹4 LPA
- Opportunity to work in medical device regulatory affairs
- Exposure to global regulatory standards
- Experience in clinical evaluation and post-market surveillance
- Career growth in Regulatory Affairs and compliance roles
Job Details
| Field | Details |
|---|---|
| Position | Executive / Sr Executive – Regulatory Affairs |
| Company | Zuche Pharmaceuticals |
| Industry | Pharmaceutical & Life Sciences |
| Employment Type | Full-time |
| Experience | 0 – 5 years |
| Education | B.Pharm / M.Pharm |
| Location | New Delhi, India |
| Salary | ₹2.5 – ₹4 LPA |
How to Apply
