Viharsh Lifescience Hiring For Regulatory Affairs Officer

Viharsh Lifescience Pvt. Ltd. is actively hiring skilled professionals in Regulatory Affairs for Finished Products & API (ROW markets). This is an excellent opportunity for pharma professionals looking to build a career in global regulatory submissions and compliance.

With a strong focus on compliance, quality, and integrity, the company offers a dynamic work environment and exposure to international regulatory projects.

🏢 Job Overview

• Role: Regulatory Affairs Officer / Executive
• Department: Regulatory Affairs (Finished Product & API – ROW)
• Location: Ahmedabad, Gujarat
• Experience: 6 Months – 3 Years
• Qualification: B.Pharm / M.Pharm
• Preferred: Ahmedabad local candidates & immediate joiners
• Working Hours: 9:30 AM – 6:30 PM

🔑 Key Responsibilities

• Prepare and compile CTD/ACTD dossiers for ROW markets
• Handle regulatory query responses and submissions
• Work on PSUR, RMP, and PSMF documentation
• Open/close Drug Master Files (DMF)
• Support BE study protocols and clinical regulatory documentation
• Prepare AMV protocols, reports, and chromatograms
• Develop Process Validation (PV) protocols and reports
• Conduct Nitrosamine risk assessments and reports
• Manage stability studies and product development reports (PDR)
• Prepare BMR/BPR documentation
• Draft SmPC leaflets and product inserts
• Compile and review technical dossier documents
• Contribute to global ROW regulatory projects

🎓 Qualifications & Skills

• Bachelor’s or Master’s degree in Pharmacy (B.Pharm / M.Pharm)
• Knowledge of CTD/eCTD, DMF, and global regulatory guidelines (ROW)
• Familiarity with ICH guidelines and dossier preparation
• Strong documentation, analytical, and communication skills
• Ability to work on multiple regulatory submissions

🎁 Benefits

• Opportunity to work on global regulatory affairs projects
• Exposure to API & Finished Product submissions
• Career growth in a quality-driven pharma company
• Collaborative and experienced team environment
• Hands-on experience with international compliance standards

📩 How to Apply

• Email: director@viharshlifescience.com
• Location: Office No. 514, 5th Floor, Satyamev Elite, Bopal, Ahmedabad