Regulatory Affairs Intern

Project Objective:

To enhance efficiency, accessibility, and traceability of regulatory documentation by using the compliance tracking tool; Ricago and IT tools to support timely submissions of documentation to government authorities for sale permissions under Seed Licenses and aligning NBA approvals with Phenome.

Project Overview:

This project, reporting to the Regional Regulatory Affairs Manager, Asia, is focused on strengthening East-west Seed India's document management systems and compliance tracking processes. Regulatory Affairs relies heavily on accurate documentation. In India, maintaining a Seed License for the sale of seeds in every state requires documentation in state-specific formats, which include Breeder Certificates, Morphological Characters, and DUS data. These documents are essential for timely seed license renewals and new product additions to allow for the sale of seeds under state laws. Currently, this process relies on manual documentation, follow-up with breeders, and manual tracking by the team. The intern's role is to automate this system, starting with the EWIN framework, to enhance document accessibility and traceability, ensuring timely license renewal and sale permission, and updating the current available license with products on the Ricago portal (compliance tool). This involves close coordination with cross-functional teams, including IT, R&D, Sales and RA, with a long-term goal of rolling out the automated system to other countries.

Key Responsibilities :

1. Regulatory Document Consolidation & Standardization

• Collaborate with the Regulatory Affairs (RA) and Breeding teams to collect, organize, and standardize all regulatory documentation required for state-wise seed license applications and renewals.
• Documents to be consolidated include:
• Breeder Certificates
• Morphological Character records
• DUS (Distinctness, Uniformity & Stability) data
• DNA fingerprinting records
• Ensure documentation is structured, complete, and readily accessible for regulatory submissions.

2. Automated Document Retrieval System Development

• Work closely with the IT team to support the development and enhancement of an automated regulatory document storage and retrieval system.
• Assist in:
• Defining document structure and categorization
• Testing system usability and retrieval efficiency
• Supporting validation during implementation phase.

3. Compliance Portal Management

• Coordinate with the Ricago team to:
• Upload all current Seed Licenses and Product Endorsements on the Ricago compliance portal.
• Track validity timelines and maintain accurate records.
• Ensure documentation traceability for renewals and compliance monitoring.
• Maintain ongoing updates for new endorsements throughout the project duration.

4. Germplasm & NBA Approval Tracking

• Work with Regulatory Affairs to review existing approvals covering 7,685 germplasm lines across 17 crops approved under the NBA Amnesty Scheme.
• Coordinate with the Phenome/Breeding team to:
• Identify and eliminate non-active germplasm lines.
• Maintain updated tracking records.
• Support RA in preparing crop-wise status reports for submission to the National Biodiversity Authority (NBA).

Key Deliverables

1. Development of a structured and standardized repository of all required regulatory documents for identified varieties state wise.
2. A functional and tested automated system for efficient storage and retrieval of regulatory documentation, integrated with the EWIN framework.
3. Updated and traceable records of all current Seed Licenses and Product Endorsements in the Ricago compliance tracking portal.
4. Preparation of a consolidated status report for National Biodiversity Authority (NBA) approved germplasm lines, with active/unused lines categorized and validated.

Qualification Required: Graduate / Post Graduate in Agriculture

Experience : Fresher

Internship Period : 6 Months