Job Title: Pharma Regulatory Assistant
Location: Bangalore, Karnataka, India
Division: Regulatory Affairs
Employment Type: Full-Time
Syngene International Ltd. is an innovation-led contract research, development, and manufacturing organization (CRDMO) providing integrated scientific services across the drug development lifecycle, from early discovery to commercial supply.
At Syngene, safety, quality, and compliance are at the core of every operation. The organization fosters a culture of accountability, environmental, health, and safety (EHS) mindfulness, and operational discipline, ensuring safe and efficient processes across all teams.
Syngene is seeking a Pharma Regulatory Assistant to support the Regulatory Affairs team in operational and documentation activities. The role involves preparing, submitting, and maintaining regulatory documentation in compliance with GxP and other applicable regulatory requirements. This position is ideal for candidates with strong learning acumen, attention to detail, and a proactive approach to regulatory operations.
Assist in preparation and submission of regulatory applications to authorities, including Test Licenses, Import Licenses, and Export Licenses.
Maintain regulatory databases, trackers, and documentation systems to ensure audit readiness and traceability.
Ensure accurate and timely updating and storage of all regulatory records.
Monitor regulatory changes and updates to support compliance initiatives.
Collaborate with cross-functional teams to gather necessary information for regulatory submissions.
Contribute to process improvements, standard operating procedures (SOPs), and compliance initiatives aligned with organizational and regulatory standards.
Support the team in achieving regulatory and quality objectives while adhering to safety and EHS protocols.
Postgraduate degree in Science or B. Pharm.
Demonstrated capability, strong learning acumen, and a hardworking attitude.
Knowledge of regulatory documentation practices and operational workflows.
1–3 years of relevant experience in regulatory operations or pharmaceutical documentation preferred (freshers may be considered if highly motivated).
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Strong problem-solving and analytical skills.
Ability to learn continuously and adapt to evolving regulatory requirements.
Attention to detail, organizational skills, and time management.
Effective communication skills and the ability to work collaboratively in a team environment.
Work with a global, innovation-driven CRDMO in regulatory affairs.
Gain exposure to regulatory submissions, licensing processes, and compliance operations.
Opportunity to grow within a highly professional, cross-functional, and global team.
Contribute to maintaining the highest standards of quality, safety, and regulatory compliance.
Equal Opportunity Employer:
Syngene is committed to providing equal employment opportunities to all individuals. Employment decisions are made without discrimination based on age, color, nationality, disability, gender, sexual orientation, religion, or any other legally protected characteristic. Reasonable accommodations are provided to qualified individuals with disabilities.
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