Regulatory Affairs_ Trainee_ M.Pharm

Profile: Trainee – Regulatory Affairs (M.Pharm Only)

Location: Gurgaon, Haryana, India (Onsite)

Role Overview

We are looking for a proactive and detail-oriented Regulatory Affairs Trainee to join our team. This role is designed for individuals looking to bridge the gap between internship and full-time professional roles in the Regulatory Affairs field. The Trainee will gain hands-on experience in global regulatory submissions and lifecycle management of pharmaceutical products, with a focus on CTD/eCTD documentation, regulatory compliance, and dossier preparation.

Job Descriptions

• Understanding the regulatory landscape and regulatory documentation standards
• Familiarization with CTD/eCTD structure and components
• Exposure to regulatory submission guidelines across global markets (EU, US, and emerging markets)
• Hands-on training in electronic publishing tools and submission validation
• Preparation, assembly, and submission of regulatory dossiers under guidance
• Managing regulatory product lifecycle, including maintenance and variations for global markets
• Interacting with regulatory teams to ensure submission compliance Roles & Responsibilities
• Assist in assembling and preparing regulatory dossiers for global submission
• Operate and validate eCTD publishing tools in line with industry standards
• Support in end-to-end regulatory submission processes, ensuring compliance and quality
• Participate in project tracking and management, including maintenance of product history logs and trackers
• Review annotated artwork and labelling texts for regulatory compliance.
• Draft and review regulatory authority responses and ensure clarity and regulatory alignment
• Collaborate with internal teams and external stakeholders to ensure timely submission and updates
  
  

Education & Experience

• Bachelor’s / master’s degree in pharmacy / Life Sciences
• Regulatory Affairs certification (optional but preferred)
  
  

Knowledge, Skills And Abilities

• Excellent written and verbal communication skills with a strong attention to detail.
• Proficiency in regulatory submission software and MS Office applications.
• Good problem-solving and coordination skills
• Ability to work in a fast-paced, deadline-driven environment
  
  

Behavioural Competencies

• Detail-oriented with high focus on quality and compliance
• Strong team player with collaborative mindset
• Ability to handle pressure and manage multiple submissions simultaneously.
  
  

Why To Join Us

• Growth Opportunities
• Learning Exposure
• Better Compensation
  
  

Related

Manager _US_ (Onsite)- Gurugram

Job Purpose: We are seeking a detail-oriented and proactive Regulatory Affairs Specialist to support global regulatory submissions and lifecycle management for pharmaceutical products. The ideal candidate will have hands-on experience with CTD/eCTD documentation, regulatory compliance, and dossier preparation, particularly for US Markets. Key Responsibilities: Regulatory Compliance:Strong understanding of U.S. regulatory…

Manager – Regulatory Affairs – EU_ Onsite

Job Title: Assistant Manager – Regulatory Affairs (EU & UK)Location: Gurgaon, Haryana (India)Experience: 4–6 YearsQualification: Master’s Degree in Pharmacy (M.Pharm or equivalent) Role OverviewWe are seeking a proactive and detail-oriented Assistant Manager – Regulatory Affairs to join our Global Regulatory team. The ideal candidate will be responsible for driving CMC documentation,…

Manager _ Medical Writing_ Regulatory Affairs

Job Purpose: DDReg Pharma Pvt Ltd is seeking an experienced Regulatory Affairs Medical Writer responsible for drafting, reviewing, and ensuring the accuracy of scientific and regulatory documents in alignment with global standards. The role involves preparation of complex CTD modules, quality control of submissions, gap analysis, and support in responding…