Website:
stavrospharma.com
Job details:
Company Description Stavros Pharmaceuticals Pvt. Ltd. is a new-age pharmaceutical company focused on becoming a global healthcare leader through quality and innovation. The organization emphasizes scientific excellence and continuous innovation, working to deliver breakthrough healthcare solutions that address evolving needs across the medical community. A dedicated team of professionals drives research and development to ensure every product meets rigorous quality standards. Stavros integrates the latest advancements in science and technology into its products, reflecting a strong commitment to improving lives and shaping the future of medicine.
Role Description This is a full-time, on-site role for a Drug Regulatory Affairs Executive at the OSD (Oral Solid Dosage) plant, located in the Amritsar/Ludhiana area. The individual in this role will prepare, review, and maintain regulatory documentation and dossiers for national and international markets. Day-to-day responsibilities include interpreting and applying regulatory requirements, coordinating with cross-functional teams for data collection, and ensuring timely submission of regulatory filings. The role involves monitoring regulatory changes, supporting audits and inspections, and maintaining compliance with applicable pharmaceutical regulations and guidelines. The executive will collaborate with quality, production, and R&D teams to support product approvals, variations, and lifecycle management in the pharma industry.
Qualifications
- Candidates should possess strong skills in Regulatory Affairs and a solid understanding of Regulatory Requirements within the pharmaceutical industry.
- Candidates should possess skills in Regulatory Documentation and Dossier Preparation for national and international regulatory submissions.
- Candidates should possess experience in Regulatory Compliance, including adherence to relevant guidelines, standards, and local/global regulations.
- Minimum 3+ years of regulatory experience in the pharma industry, preferably in OSD formulations.
- Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, or a related field.
- Strong attention to detail, analytical skills, and ability to interpret regulatory guidelines.
- Effective communication, documentation, and coordination skills for cross-functional collaboration.
- Experience with regulatory portals, documentation management systems, and MS Office tools is beneficial.
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