Ra Executive

Trident Lifeline; Surat; On-site; INR 300,000 - 600,000; Full time

Job summary

Trident Lifeline is seeking a Regulatory Affairs Executive to manage regulatory submissions and lifecycle activities for ROW and Latin America markets. The role requires coordinating with R&D, QA, production, and international customers to ensure compliance with all country regulations.

You will prepare CTD/eCTD dossiers, review labels and documentation, and maintain filing systems while tracking registrations and responding to authorities within defined timelines.

Qualifications

• Knowledge of CTD/eCTD dossier preparation.
• Understanding of pharmaceutical registration requirements for ROW and Latin American markets.
• Good knowledge of pharmaceutical documentation and regulatory guidelines.
• Strong documentation, analytical, and communication skills.
• Proficiency in MS Office.
• Ability to coordinate with multiple departments and international customers.

Responsibilities

• Prepare, compile, review, and submit dossiers for ROW and Latin American markets.
• Handle CTD/eCTD documentation and country-specific regulatory requirements.
• Prepare and review product registration documents, renewals, variations, amendments, and deficiency responses.
• Coordinate with R&D, QA, QC, Production, and International Marketing teams for regulatory documentation.
• Review product labels, artworks, pack inserts, and regulatory compliance documents.
• Track product registrations and maintain regulatory databases.
• Respond to regulatory authority queries within defined timelines.
• Ensure compliance with country-specific regulatory guidelines.
• Maintain regulatory documentation and filing systems.
• Support new product registrations and existing product lifecycle management.

Skills

CTD/eCTD dossier prep

ROW/Latin America regulatory

Regulatory documentation

Documentation & analysis

MS Office proficiency

Cross-department coordination

Education

B.Pharm / M.Pharm (Mandatory)

Job description

Regulatory Affairs (RA) Executive

Job Summary

We are looking for a Regulatory Affairs Executive with sound knowledge of pharmaceutical regulatory documentation and international registration processes. The candidate will be responsible for handling regulatory submissions and lifecycle management for ROW (Rest of World) and Latin America markets while coordinating with internal departments and overseas customers.

Key Responsibilities

• Prepare, compile, review, and submit dossiers for ROW and Latin American markets.
• Handle CTD/eCTD documentation and country-specific regulatory requirements.
• Prepare and review product registration documents, renewal dossiers, variations, amendments, and deficiency responses.
• Coordinate with R&D, QA, QC, Production, and International Marketing teams for regulatory documentation.
• Review product labels, artworks, pack inserts, and regulatory compliance documents.
• Track product registrations and maintain regulatory databases.
• Respond to regulatory authority queries within defined timelines.
• Ensure compliance with country-specific regulatory guidelines.
• Maintain regulatory documentation and filing systems.
• Support new product registrations and existing product lifecycle management.

Required Skills

• Knowledge of CTD/eCTD dossier preparation.
• Understanding of pharmaceutical registration requirements for ROW and Latin American markets.
• Good knowledge of pharmaceutical documentation and regulatory guidelines.
• Strong documentation, analytical, and communication skills.
• Proficiency in MS Office.
• Ability to coordinate with multiple departments and international customers.

Qualification

• B.Pharm / M.Pharm (Mandatory)

Preferred Experience

• Experience in handling regulatory submissions for ROW, Latin America, Africa, CIS, or other international markets.
• Knowledge of dossier compilation, product registration, renewals, and regulatory compliance.

Key Competencies

• Attention to detail
• Documentation skills
• Regulatory knowledge
• Time management
• Teamwork and coordination
• Problem-solving ability