Pharma Regulatory Assistant Job in Bangalore at Syngene for B.Pharm and postgraduates supporting regulatory documentation and submissions.
About the Company
Syngene International Limited is an innovation-led Contract Research, Development, and Manufacturing Organization (CRDMO) providing integrated scientific services from early discovery through commercial manufacturing. Syngene supports global pharmaceutical, biotechnology, and life sciences companies by offering high-quality research, development, and manufacturing solutions that meet international regulatory and compliance standards.
With a strong focus on safety, integrity, and operational excellence, Syngene places employee well-being and regulatory compliance at the core of its business operations. Safety is treated on par with business performance, and all employees are expected to actively contribute to a culture that prioritizes Environment, Health, and Safety (EHS), data integrity, and quality systems. Pharma Regulatory Assistant Job
This Pharma Regulatory – Assistant position is part of Syngene’s regulatory operations support team and offers an excellent opportunity for early-career professionals to build a strong foundation in pharmaceutical regulatory affairs within a globally respected organization.
Job Details
- Job Title: Pharma Regulatory – Assistant
- Job Grade: Associate – Team Lease
- Division: Essential Functions
- Location: Bangalore, Karnataka
- Industry: Pharmaceutical / Regulatory Affairs / Life Sciences
- Employment Type: Full-Time
- Experience Level: Entry-level to Junior
- Education Required: Postgraduate in Science or B.Pharm
This role is ideal for candidates looking to begin or strengthen their career in pharma regulatory affairs and regulatory operations. Pharma Regulatory Assistant Job
Job Description
The Pharma Regulatory – Assistant will support the Regulatory Affairs team in managing regulatory operations activities in compliance with GxP requirements. The role primarily focuses on preparation, submission, and maintenance of regulatory documentation related to licenses and approvals required for pharmaceutical operations. Pharma Regulatory Assistant Job
The selected candidate will work closely with cross-functional teams to collect, organize, and submit accurate regulatory information to relevant regulatory authorities. This position requires attention to detail, strong documentation skills, and a willingness to continuously learn regulatory processes and evolving compliance requirements.
In addition to regulatory responsibilities, the role carries a strong emphasis on safety, quality, and integrity, aligning with Syngene’s organizational values and safety-first culture. Pharma Regulatory Assistant Job
Core Purpose of the Role
The core purpose of this role is to support Pharma Regulatory Affairs activities as an Associate by assisting in regulatory operations, including preparation, submission, tracking, and maintenance of regulatory documentation in compliance with GxP and internal quality standards. Pharma Regulatory Assistant Job
Key Responsibilities
- Assist in the preparation of regulatory applications and submissions to regulatory authorities
- Support applications for Test Licenses, Import Licenses, and Export Licenses
- Maintain regulatory databases, trackers, and document repositories
- Ensure regulatory records are accurate, complete, and audit-ready
- Support document version control, archiving, and traceability
- Monitor and track regulatory submissions, approvals, and renewals
- Assist in monitoring regulatory updates, changes, and notifications
- Coordinate with internal departments to collect required regulatory information
- Ensure compliance with Syngene’s quality standards and data integrity requirements
- Support internal and external audits by providing regulatory documentation
- Follow standard operating procedures (SOPs) and regulatory guidelines at all times
Pharma Regulatory Assistant Job
Safety, Quality, and Compliance Responsibilities
At Syngene, safety and compliance are mandatory expectations for all roles. The Pharma Regulatory – Assistant is expected to:
- Adhere strictly to safety practices, procedures, and SOPs
- Contribute to the development and improvement of safe work practices
- Promote a strong Environment, Health, and Safety (EHS) culture
- Ensure personal and team compliance with safety protocols
- Complete all mandatory training related to safety, health, and data integrity on time
- Comply with Syngene’s quality and integrity standards consistently
- Support governance and periodic review of safety and compliance metrics
- Take accountability for meeting assigned safety and compliance goals
Skills / Qualifications
Educational Qualification
- Postgraduate degree in Science
- Bachelor of Pharmacy (B.Pharm)
Technical Skills
- Good working knowledge of Microsoft Word, Excel, and PowerPoint
- Basic understanding of regulatory documentation and compliance concepts
- Familiarity with document management and tracking systems is an advantage
Functional and Behavioral Skills
- Strong learning acumen and willingness to develop regulatory expertise
- Hardworking and detail-oriented approach
- Good problem-solving and analytical skills
- Ability to manage multiple tasks and meet timelines
- Strong organizational and documentation skills
- Willingness to engage in continuous learning opportunities
Pharma Regulatory Assistant Job
Syngene Values
All employees are expected to demonstrate consistent alignment with Syngene’s core values:
- Excellence: Commitment to high-quality work and continuous improvement
- Integrity: Ethical conduct, transparency, and accountability
- Professionalism: Respectful collaboration and responsible behavior
These values guide daily work, decision-making, and interactions with colleagues and stakeholders. Pharma Regulatory Assistant Job
Benefits / Perks
While specific benefits may vary based on employment terms under Team Lease, working with Syngene offers: Pharma Regulatory Assistant Job
- Exposure to global regulatory and compliance environments
- Opportunity to work within a reputed CRDMO organization
- Strong learning and professional development environment
- Experience in regulated pharmaceutical operations
- Structured work culture with emphasis on safety and quality
- Long-term career value through regulatory domain exposure
Why You Should Join
This Pharma Regulatory – Assistant role is an excellent opportunity for science and pharmacy graduates who want to build a career in regulatory affairs. Working at Syngene provides hands-on exposure to regulatory operations, licensing activities, and compliance systems used in global pharmaceutical environments. Pharma Regulatory Assistant Job
The role allows candidates to develop strong documentation, coordination, and regulatory knowledge skills while working in a safety-focused, quality-driven organization. It is especially suitable for candidates who value structured learning, compliance excellence, and long-term career growth in the pharmaceutical industry. Pharma Regulatory Assistant Job
Equal Opportunity Employer
Syngene is an equal opportunity employer and provides employment opportunities without discrimination based on age, color, nationality, citizenship, disability, race, religion, gender, sexual orientation, gender identity or expression, marital status, veteran status, or any other characteristic protected by applicable laws.
Syngene also provides reasonable accommodation for qualified individuals with disabilities in accordance with applicable legislation. Pharma Regulatory Assistant Job
How to Apply
FAQs
Q1. Is this role suitable for freshers?
Yes, this role is suitable for entry-level candidates with relevant educational qualifications.
Q2. Is prior regulatory experience mandatory?
Prior experience is not mandatory, but basic understanding and willingness to learn regulatory processes are important.
Q3. What type of regulatory work is involved?
The role involves regulatory operations such as license applications, documentation management, and compliance support.
Q4. Where is the job located?
The job is based in Bangalore, Karnataka.
Q5. What is the employment grade?
The position is at Associate level under Team Lease.
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