Viharsh Life Science Pvt. Ltd., a growing pharmaceutical organization focused on compliance, quality, and integrity, is inviting applications from experienced Regulatory Affairs professionals for the position of Regulatory Officer to Senior Officer. This opportunity is ideal for candidates with expertise in ROW (Rest of World) regulatory submissions, dossier preparation, and pharmaceutical documentation management.The company is looking for motivated professionals who can contribute to global regulatory projects while working in a quality-driven and compliant environment.
Job Overview
Position: Regulatory Affairs – Regulatory Officer to Sr. OfficerVacancies: 3Location: Ahmedabad, Gujarat (Local Candidates Preferred)Experience: 1 Year and Above (Experienced Candidates Only)Qualification: B.Pharm / M.PharmWorking Hours: 9:00 AM to 6:00 PM
Key Responsibilities
Selected candidates will be responsible for:Preparation and compilation of CTD/ACTD dossiers for ROW countries.Preparation of regulatory query responses.Handling PSUR, RMP, and PSMF documentation.Opening and closing activities related to DMF.Supporting BE study protocols and clinical regulatory documentation.Preparation of AMV protocols, reports, and chromatograms.Compilation and review of Clinical Development Plans (CDP).Preparation of Nitrosamine risk assessment reports.Development of Process Validation (PV) protocols and reports.Stability study documentation and management.Preparation of Product Development Reports (PDR).BMR/BPR preparation and review.SmPC and package leaflet preparation.Preparation, review, and maintenance of technical dossier documents.
Why Join Viharsh Life Science?
Opportunity to work on global ROW regulatory projects.Exposure to international pharmaceutical regulatory requirements.Career growth with a dynamic and experienced team.Strong compliance and quality-focused work culture.Contribution to high-quality global pharmaceutical submissions.
Contact Details
Viharsh Life Science Pvt. Ltd.Office No. 514, 5th Floor, Satyamev Elite,Above Zudio, Opp. BRTS Junction,Bopal, Ahmedabad, Gujarat, IndiaMobile: +91 8320731621Email: director@viharshlifescience.com
Technical FAQs
1. What is a CTD/ACTD dossier in Regulatory Affairs?CTD (Common Technical Document) and ACTD (ASEAN Common Technical Dossier) are internationally accepted formats for pharmaceutical product registration submissions. They contain administrative, quality, non-clinical, and clinical information required by regulatory authorities for product approval.2. What is the role of PSUR, RMP, and PSMF in pharmacovigilance?PSUR (Periodic Safety Update Report): Evaluates the benefit-risk profile of a marketed product.RMP (Risk Management Plan): Identifies and manages product-related risks.PSMF (Pharmacovigilance System Master File): Documents the pharmacovigilance system maintained by a company.3. What is a Drug Master File (DMF)?A DMF is a confidential document submitted to regulatory authorities that contains detailed information about the facilities, processes, packaging, and storage of pharmaceutical ingredients used in drug manufacturing.4. Why are Process Validation and Stability Studies important?Process Validation confirms that manufacturing processes consistently produce products meeting quality standards. Stability Studies determine product shelf life and ensure safety, efficacy, and quality throughout storage and distribution.5. What is Nitrosamine Risk Assessment in pharmaceuticals?Nitrosamine Risk Assessment is a regulatory requirement used to identify, evaluate, and control potential nitrosamine impurities in pharmaceutical products. Regulatory agencies worldwide require manufacturers to monitor and minimize these impurities due to potential health risks.
Conclusion
The Regulatory Affairs opening at Viharsh Life Science Pvt. Ltd. offers an excellent opportunity for experienced B.Pharm and M.Pharm professionals seeking exposure to international regulatory submissions and pharmaceutical compliance activities. Candidates with expertise in dossier preparation, pharmacovigilance documentation, validation, and regulatory compliance are encouraged to apply and become part of a growing global pharmaceutical organization.
Viharsh Life Science Pvt. Ltd. Hiring Regulatory Affairs Professionals – Regulatory Officer to Sr. Officer
The post Viharsh Life Science Pvt. Ltd. Hiring Regulatory Affairs Professionals – Regulatory Officer to Sr. Officer appeared first on The Jobs Post –Job Alerts for Freshers & Experts.
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