Regulatory Affairs Executive

Company Description Rhombus Pharma Pvt. Ltd. is a growth-oriented pharmaceutical company committed to delivering high-quality, safe, and effective medicines. The organization focuses on innovation, operational excellence, and compliance with national and international regulatory standards. Team members collaborate across functions to support product development, registration, and market expansion. The company offers opportunities to work on diverse regulatory projects and contribute to the availability of reliable healthcare solutions. Rhombus Pharma values integrity, accuracy, and continuous improvement in all aspects of its operations.
Role Description This is a full-time, on-site Regulatory Affairs Executive role based in Kadi. The Regulatory Affairs Executive will prepare, compile, and review regulatory dossiers for domestic and international submissions, ensuring alignment with current regulatory requirements. Responsibilities include managing regulatory documentation, maintaining product registration files, and coordinating with internal teams such as quality assurance, production, and R&D to gather necessary data. The role involves monitoring changes in regulatory guidelines, supporting responses to regulatory queries, and ensuring ongoing regulatory compliance for existing and new products. The executive will also assist in preparing variation applications, renewals, and regulatory reports and support audits and inspections as required.
Qualifications
Strong skills in Regulatory Documentation and Dossier Preparation, with the ability to compile, review, and maintain accurate submission files.
Solid understanding of Regulatory Requirements and Regulatory Affairs processes for pharmaceutical products across relevant markets.
Demonstrated capability in ensuring Regulatory Compliance, including tracking guideline updates and implementing necessary changes.
Bachelor’s or master’s degree in Pharmacy, Pharmaceutical Sciences, or a related discipline.
Attention to detail, strong organizational skills, and the ability to manage multiple projects and deadlines.
Effective written and verbal communication skills for interaction with regulatory authorities and internal stakeholders.
Proficiency in using standard office and documentation tools; experience with electronic submission platforms is an advantage.
Prior experience in pharmaceutical regulatory affairs or a related function is preferred.

Work arrangement
No