Trainee

Job Title: Trainee/Intern

Job Location: Bengaluru

Department: Pharma Regulatory Affairs

About Syngene:  Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply.

At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit

Mandatory expectation for all roles as per Syngene safety guidelines

• 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

Role Accountabilities

• 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.

Leadership Capabilities: Not applicable

Syngene’s Values

All employees will consistently demonstrate alignment with our core values

•  Excellence
•  Integrity
•  Professionalism

Education – M Pharm (Drug Regulatory Affairs),  M Pharm MBA integrated course

Equal Opportunity Employer

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodation for qualified individuals with disabilities.