Symbio Generics is a leading pharmaceutical company committed to delivering high-quality, affordable healthcare solutions. With a strong focus on regulatory compliance and innovation, we strive to meet global standards while ensuring patient safety. Our dynamic work environment fosters professional growth and collaboration.
Job Description
We are seeking an experienced Executive – Regulatory Affairs to join our team in Bangalore. The ideal candidate will have 2-3 years of experience in regulatory submissions, compliance, and documentation within the pharmaceutical industry.
Key Responsibilities:
- Regulatory Documentation & Submissions:
- Compile and file applications for DCD & CDSCO (site manufacturing licenses, test licenses, WHO-GMP, COPP certifications).
- Prepare and submit NDA & SND applications to CDSCO (HQ).
- Handle Form-10 documentation and interact with business partners for product registrations.
- Compliance & Approvals:
- Submit documents to AQCS for Veterinary Health Certificates & GMP approvals.
- Ensure compliance with regulatory guidelines, craft deficiency responses, and track approval progress.
- Stakeholder Coordination:
- Work with R&D, QA/QC, and Manufacturing teams to gather technical documents.
- Maintain regulatory databases, track submissions, and ensure timely approvals.
- Regulatory Communication & Strategy:
- Build strong relationships with regulatory authorities.
- Develop clear communication strategies for stakeholders and share best practices.
Required Skills & Qualifications:
- Education: B.Pharm / M.Pharm
- Experience: 2-3 years in regulatory affairs (pharma industry preferred).
- Technical Skills:
- Understanding of CDSCO, WHO-GMP, and other regulatory frameworks.
- Strong documentation, data analysis, and compliance management.
- Soft Skills:
- Excellent written & verbal communication.
- Ability to work in cross-functional teams (R&D, QA, Manufacturing).
Why Join Symbio Generics?
✅ Work with a leading pharmaceutical company in regulatory compliance.
✅ Career growth opportunities in a fast-paced environment.
✅ Collaborative culture with industry experts.
How to Apply?
Interested candidates can send their CV and portfolio to:
📧 careers@symbiogenerics.com
📍 Location: Head Office, Bangalore
Don’t miss this opportunity! Apply today and be a part of our innovative team.
