Job
Description
Principal Responsibilities Ensure compliance with all company procedures, rules, and codes of practice, particularly regarding confidentiality and security of documents related to the companys business. Safeguard and prioritize the company's business interests at all times, maintaining and enhancing the companys reputation. Activities of the Regulatory Affairs & Pharmacovigilance Department: Health Authority Database Management: Responsible for maintaining and uploading data on health authority databases (SUGAM, FDA, etc.). Coordination for Product Dossier: Coordinate with global and local counterparts for product dossier preparation. Compile and submit applications for product registrations (local manufacturing and imports), including drugs, medical devices, food supplements, etc. Manage the CMC (Chemistry, Manufacturing, and Controls) section of the product dossiers. Regulatory Strategy & Compliance for Export Markets: Assist in developing and implementing regulatory strategies for the export of drug products to international markets. Ensure compliance with regulations in international markets, including Clinical Trials (CT) and Bioequivalence (BE) submissions to CDSCO. Preparation for SEC Meetings: Assist the Senior Manager/Director of Regulatory Affairs and Pharmacovigilance in preparing SEC slide decks. Organize mock SEC meetings with stakeholders and assist in other preparations for SEC meetings. Life-cycle Management: Responsible for life-cycle management activities, including labeling, CMC changes, license renewals, artwork management, and product testing in compliance with local and international regulations and company SOPs. Support artwork preparation and review. Inspection and Audit Preparation: Support the RA/PV team in planning and preparing for health authority inspections and internal audits. SOP Development and Compliance: Assist in the preparation of local SOPs. Handle quality complaints, product recalls, deviations, CAPA (Corrective and Preventive Actions), and changes, ensuring the databases are updated in accordance with local SOPs. Quality Management Systems (QMS) Compliance: Support the development and maintenance of QMS in compliance with Good Manufacturing Practices (GMP) and relevant standards. Pharmaceutical Responsibility and Compliance: Act as a deputy for the local pharmaceutical responsibility coordinator, ensuring proper documentation and implementation of pharmaceutical SOPs, quality complaint management, and reconciliation. Manage product complaints and coordinate investigations related to suspected falsified products. Assist with recall execution, coordination with involved personnel, and traceability of affected batches. Global Database Maintenance: Ensure timely data uploads and maintenance of global registration databases, complying with local and global guidance documents. General Responsibilities: Perform any other tasks relevant to the functioning of the Regulatory Affairs and Pharmacovigilance Department, as requested by management. Maintain a high level of discretion regarding confidential clinical studies and product information. Profile Requirements Minimum Requirements: Bachelors in Pharmacy or Masters in Science with 7-8 years of operational experience in handling regulatory and pharmacovigilance activities; MBBS/M. Pharm/Ph.D. (Pharmacology/ Pharmaceutics) graduates preferred. In-depth understanding of CMC, non-clinical, and clinical data aspects for regulatory submissions. Proficiency in MS Office (Word, PowerPoint, Excel, etc.). Ability to manage regulatory and PV activities in the absence of the Senior Manager. Indispensable Qualities: Professional and discreet approach to job responsibilities. Tactful in face-to-face meetings and interactions. Strong communication skills, both oral and written. Ability to work independently with minimal guidance. Flexible and capable of prioritizing tasks effectively. Energetic, enthusiastic, and committed to tasks. Ability to adhere to systems and standards while maintaining cordial relations. Competencies Required for the Job: Regulatory Knowledge: Ability to adhere to local (CDSCO) and international market regulations, and other legally enforceable requirements. Drug Development Knowledge: Understanding of the drug development process from discovery to market introduction. Responsiveness: Ability to mobilize resources and implement solutions quickly. Risk/Benefit Analysis: Ability to assess and quantify the risk and benefits associated with drug products. Scientific Knowledge: Ability to accumulate knowledge systematically and apply it to general principles. Learning Agility: Ability to rapidly learn and retain new information without compromising comprehension. Synthesis: Ability to bring together various elements of knowledge into a coherent, structured understanding. Adaptability: Ability to adjust behavior and actions according to different environments, issues, and stakeholders. Pedagogy: Ability to effectively teach and transmit knowledge using appropriate methods.
