Pharma Regulatory Assistant Job in Bangalore – B.Pharm / PG Science | Syngene

Job Opportunity: Pharma Regulatory – Assistant

Location: Bangalore, Karnataka (560100)
Job Grade: Associate – Team Lease
Division: Essential Functions

About Syngene

Syngene is an innovation-led Contract Research, Development, and Manufacturing Organization (CRDMO) offering integrated scientific services ranging from early discovery to commercial supply. At Syngene, safety is a core value and is treated with equal importance as business performance. Every employee is responsible for maintaining the highest standards of safety, quality, and integrity.

Core Purpose of the Role

The Pharma Regulatory – Assistant will support Regulatory Affairs activities by assisting in regulatory operations such as preparation, submission, and maintenance of regulatory documentation in compliance with GxP requirements.

Key Responsibilities

• Assist in preparation and submission of regulatory applications to regulatory authorities, including:

  • Test License

  • Import License

  • Export License

• Maintain regulatory databases, trackers, and documentation systems.

• Ensure accurate documentation management to support audit readiness and traceability.

• Assist in monitoring regulatory updates and changes.

• Collaborate with cross-functional teams to collect required information for regulatory submissions.

• Ensure compliance with Syngene’s quality standards and regulatory guidelines at all times.

Safety & Compliance Expectations

• Adhere strictly to all Environment, Health, and Safety (EHS) policies and SOPs.

• Contribute to safe operational practices and promote a strong EHS culture.

• Complete all mandatory training related to safety, data integrity, and quality on time.

• Take accountability for personal and team safety goals.

• Support governance and review of safety metrics periodically.

Required Qualifications

• Education: Postgraduate in Science or B.Pharm

• Experience Level: Entry-level / Associate

• Attributes:

  • Strong learning acumen

  • Hard-working and detail-oriented

  • Willingness to engage in continuous learning

Skills & Capabilities

• Proficiency in Microsoft Office (Word, Excel, PowerPoint)

• Strong problem-solving abilities

• Good documentation and organizational skills

• Ability to work collaboratively with cross-functional teams

Syngene Core Values

All employees are expected to demonstrate alignment with Syngene’s values of:

• Excellence

• Integrity

• Professionalism

Why Join Syngene?

• Work in a globally recognized scientific organization

• Gain exposure to regulatory operations in the pharmaceutical industry

• Be part of a safety-first, quality-driven culture

• Opportunity for professional growth and continuous learning

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