Entry-Level Regulatory Affairs Assistant

Syngene International; Bengaluru; On-site; INR 300,000 - 420,000; Full time

Job summary

Syngene International Limited in Bengaluru is seeking a Pharma Regulatory Assistant to support regulatory documentation, licensing submissions, and compliance under GxP. Freshers with B.Pharm or a science postgrad are welcome.

The role offers exposure to global regulatory operations within a renowned CRDMO, fostering growth in pharmaceutical regulatory affairs and data integrity practices.

Qualifications

• B.Pharmacy or postgraduate science qualification required.
• Fresher or early-career professionals encouraged to apply.
• Willingness to work in documentation-driven, compliance-focused environments.

Responsibilities

• Support regulatory documentation, licensing, and compliance under GxP.
• Assist in preparation, submission, and maintenance of regulatory records.
• Maintain regulatory databases, trackers, and document management systems.
• Coordinate with cross-functional teams to collect regulatory information.
• Ensure accuracy, audit-readiness, and adherence to quality standards.
• Monitor regulatory updates relevant to pharmaceutical operations.

Skills

Attention to detail

Documentation

Strong learning ability

Communication

Coordination

Education

B.Pharmacy

Postgraduate degree in Science

Tools

MS Word

MS Excel

PowerPoint

Job description

Syngene hiring Pharma Regulatory Assistant in Bangalore. B.Pharm/Postgraduate Science eligible. Regulatory operations & GxP exposure.

Syngene International Limited is hiring a Pharma Regulatory Assistant for its Bangalore operations to support regulatory affairs and regulatory operations activities. This role is ideal for pharmacy and postgraduate science professionals who want hands-on exposure to GxP-compliant regulatory documentation, licensing submissions, and regulatory operations within a globally respected contract research and manufacturing organization. The position offers structured learning, strong compliance exposure, and a clear foundation for long-term growth in pharmaceutical regulatory affairs.

Company Overview

Syngene International Limited is an innovation-led contract research, development, and manufacturing organization (CRDMO) providing integrated scientific services from early discovery through commercial supply. The company partners with global pharmaceutical, biotechnology, and life sciences organizations and is known for its strong compliance culture, scientific excellence, and ethical standards.

Safety, quality, and integrity are core pillars at Syngene. The organization places environment, health, and safety (EHS) at the same priority level as business performance, with shared accountability across all roles. Syngene’s regulatory and quality-driven ecosystem makes it an ideal workplace for professionals seeking real-world exposure to global regulatory operations and data integrity practices.

Job Role & Responsibilities

The Pharma Regulatory Assistant will support regulatory operations activities related to regulatory documentation, licensing, and compliance under GxP requirements.

Pharma Regulatory Assistant - Regulatory Operations

Key Responsibilities

• Assist in preparation, submission, and maintenance of regulatory documentation in compliance with GxP requirements
• Support applications for Test License, Import License, and Export License submissions
• Maintain regulatory databases, trackers, and document management systems
• Ensure regulatory records are accurate, current, and audit-ready
• Support traceability and documentation control for regulatory submissions
• Monitor regulatory updates and changes relevant to pharmaceutical operations
• Coordinate with cross-functional teams to collect and compile regulatory information
• Ensure adherence to Syngene quality standards and data integrity requirements

Safety & Compliance Responsibilities

• Adhere strictly to environment, health, and safety (EHS) guidelines and SOPs
• Ensure completion of mandatory trainings related to safety, data integrity, and quality
• Contribute to safe work practices and continuous improvement initiatives
• Support governance and review of safety and compliance metrics

Eligibility / Qualifications

Educational Requirements

• B.Pharmacy or Postgraduate degree in Science

Relevant Courses (comma-separated): B.Pharmacy, M.Pharmacy, M.Sc Chemistry, M.Sc Life Sciences, Pharmaceutical Sciences

Experience & Capability Requirements

• Freshers or early-career professionals with strong learning ability preferred
• Basic understanding of pharmaceutical regulatory concepts
• Willingness to work in documentation-driven, compliance-focused environments

Skills & Competencies

• Good working knowledge of Microsoft Word, Excel, and PowerPoint
• Strong attention to detail and documentation accuracy
• Problem-solving and analytical thinking skills
• Ability to engage in continuous learning
• Professional communication and coordination skills

Location & Salary

• Job Location: Bangalore, Karnataka - 560100
• Employment Type: Full-time (Associate - Team Lease)
• Salary: As per company standards and role level (to be discussed during selection)

Frequently Asked Questions

Who can apply for this Pharma Regulatory Assistant role?

Candidates with B.Pharm or postgraduate science qualifications can apply.

Is this a fresher-friendly role?

Yes. This role is suitable for freshers and early-career professionals with strong learning ability.

What regulatory activities will I support?

You will support license applications, regulatory documentation, and regulatory operations activities.

Where is the job located?

The position is based in Bangalore, Karnataka.

How do I apply?

Apply through the official Syngene career portal using the provided link.