Executive - Plant DRA

As an Executive in Drug Regulatory Affairs (DRA) at our Manufacturing Plant in Surendranagar, your role is crucial in ensuring compliance with regulatory requirements related to drug manufacturing and submissions. You will be responsible for coordinating with various departments to gather, review, and submit necessary documentation to meet regulatory standards. **Key Responsibilities:** - **Regulatory Compliance:** - Ensure compliance with all regulatory requirements at the manufacturing plant, including local and international guidelines. - Assist in the preparation, review, and submission of regulatory documents related to drug manufacturing. - **Documentation and Submission:** - Collect, compile, and organize data and documents required for regulatory submissions. - Coordinate with Quality Assurance, Production, and R&D teams for accurate and timely submission of documents to Corporate DRA. - **Regulatory Support:** - Coordinate and follow up on regulatory matters related to the manufacturing plant. - Assist in preparing responses to queries from regulatory authorities and provide necessary documentation. - **Change Control Management:** - Participate in change control processes to document any changes in manufacturing processes or product specifications. - **Audit and Inspection Support:** - Support internal and external audits by ensuring regulatory documentation is up-to-date and available. - Assist in addressing audit findings and implementing corrective actions for regulatory compliance. - **Regulatory Intelligence:** - Stay updated on changes in regulatory guidelines impacting manufacturing operations. - Communicate relevant updates to Corporate DRA and manufacturing teams. - **Cross-Functional Collaboration:** - Work closely with QA, Production, and R&D teams to ensure alignment on regulatory requirements. - Act as a liaison between the manufacturing plant and Corporate DRA for regulatory matters. - **Training and Development:** - Participate in regulatory affairs training programs to enhance knowledge. - Provide training to plant personnel on regulatory compliance and documentation practices. **Qualifications:** - **Education:** Bachelor's degree in Pharmacy - **Experience:** 2-4 years in a regulatory affairs role within the pharmaceutical industry, preferably in a manufacturing environment. - **Knowledge:** Understanding of local and international regulatory guidelines, regulatory submission processes, and documentation requirements. - **Skills:** Excellent communication, interpersonal, attention to detail, organizational abilities, collaboration, and proficiency in MS Office Suite and regulatory software tools. In this role, you will have the opportunity to work in a dynamic regulatory environment, gain hands-on experience in regulatory submissions and compliance, and grow professionally within the DRA domain.,