Trainee

Job Title:

• Overall adherence to safe practices and procedures of oneself and the teams aligned
• Contributing to the development of procedures, practices and systems that ensure safe operations and compliance with the company’s integrity & quality standards
• Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace always.
• Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements always in the workplace.
• Ensure all assigned mandatory training related to data integrity, health, and safety measures are completed on time by all members of the team including self
• Compliance with Syngene’s quality standards always
• Hold self and their teams accountable for the achievement of safety goals
• Govern and Review safety metrics from time to time
  

Core Purpose Of The Role

• Support Regulatory Affairs team in connection with licensing activities and applications to relevant licensing authorities
  

• Assist in the preparation and compilation of regulatory dossiers for submission to relevant authorities such as DCGI, CDSCO Zonal Offices, State FDA, and NCB, ensuring alignment with applicable regulatory frameworks and submission formats.
• Support the critical review of regulatory documentation to ensure accuracy, completeness, and adherence to national and international regulatory guidelines and standards.
• Collaborate with cross-functional teams including R&D, QA, QC, and manufacturing to collect and verify technical data, certificates, and other documentation required for regulatory filings.
• Monitor and track the status of regulatory submissions and approvals, maintaining detailed logs, trackers, and dashboards to ensure timely follow-ups and compliance with submission timelines.
• Conduct regulatory intelligence and literature reviews to support product registration strategies, including analysis of competitor filings, recent regulatory updates, and global best practices.
• Assist in drafting and compiling responses to regulatory queries, observations, and deficiency letters, under the guidance of senior regulatory professionals.
• Maintain and update regulatory databases, document repositories, and filing systems, ensuring audit-readiness and ease of access for internal and external stakeholders.
• Stay abreast of evolving regulatory landscapes, including updates from CDSCO, ICH, WHO, and other global agencies, and share relevant insights with the regulatory team to support proactive compliance.
  

• Excellence
• Integrity
• Professionalism