Regulatory Affairs_ Trainee_ M.Pharm
Full Time
Gurgaon
Posted 1 day ago
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