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

Related

Job Features

Job Category

Regulatory Affairs