Regulatory Affairs Officer Pharma

Why This Role Matters

Regulatory Affairs serves as the bridge between pharmaceutical companies and health authorities. In a highly regulated industry, accurate documentation, timely submissions, and strict compliance are critical for product approvals and continued market presence.
This role at APDM Pharmaceuticals plays a vital part in ensuring that products meet regulatory standards and guidelines. By managing dossiers, coordinating submissions, and maintaining regulatory documentation, the Regulatory Affairs Executive directly contributes to the company’s growth, credibility, and global expansion.

Job Description

APDM Pharmaceuticals is seeking a Regulatory Affairs Executive / Sr. Executive to manage regulatory documentation, submissions, and compliance activities. The selected candidate will be responsible for preparing and reviewing dossiers, coordinating with internal departments, and ensuring adherence to national and international regulatory requirements.
This position is suitable for pharmacy professionals who are detail-oriented, organized, and interested in regulatory strategy and pharmaceutical compliance.

Key Features of the Role

• Exposure to domestic and international regulatory processes
• Hands-on experience in dossier preparation and submissions
• Involvement in lifecycle management of pharmaceutical products
• Cross-functional coordination with QA, QC, Production, and R&D
• Opportunity to work in a compliance-driven pharmaceutical environment
• Career progression from Executive to Senior Executive level

Responsibilities

• Prepare, review, and compile regulatory dossiers for product registration
• Manage submissions to regulatory authorities as per guidelines
• Coordinate with internal departments for documentation and data collection
• Track regulatory queries and respond within defined timelines
• Maintain regulatory documentation and records systematically
• Monitor changes in regulatory requirements and update internal processes
• Support renewal applications, variations, and post-approval changes
• Ensure compliance with applicable pharmaceutical regulations
• Assist in audit preparation and regulatory inspections

Required Qualifications

• Bachelor's degree in Pharmacy or Master's degree in Pharmacy
• Experience in Regulatory Affairs within pharmaceutical industry preferred
• Knowledge of CTD/eCTD formats and regulatory documentation
• Understanding of domestic and export market regulatory requirements
• Strong documentation and communication skills

Educational Requirements

• Bachelor of Pharmacy (B.Pharm) – Mandatory
• Master of Pharmacy (M.Pharm) – Preferred
• Additional certification in Regulatory Affairs (optional advantage)

Experience and Skills

• 1 to 5+ years of experience depending on Executive / Sr. Executive level
• Familiarity with regulatory guidelines and submission processes
• Strong analytical and documentation skills
• Ability to interpret regulatory requirements
• Good coordination and time-management skills
• Proficiency in MS Office and documentation tools
• Detail-oriented and compliance-focused approach

Salary Insights

• Performance-based increments
• Standard pharmaceutical industry benefits as per company policy
Actual compensation will depend on experience, expertise, and negotiation.

Company Overview

APDM Pharmaceuticals is a pharmaceutical organization focused on manufacturing and marketing quality-driven products. The company operates in a regulated environment and emphasizes compliance, documentation accuracy, and timely regulatory approvals to maintain market competitiveness.

FAQs

Q: Is prior Regulatory Affairs experience mandatory?
A: Yes, relevant experience in pharmaceutical regulatory processes is preferred.

Q: Does this role involve international submissions?
A: Depending on business requirements, candidates may handle domestic and export market dossiers.

Q: What level determines Executive vs. Senior Executive?
A: Experience depth, handling of independent submissions, and regulatory exposure.

Q: Is CTD knowledge required?
A: Yes, familiarity with CTD/eCTD documentation formats is highly beneficial.

Application Tips

• Clearly mention markets handled (India, ROW, EU, etc.)
• Highlight CTD/eCTD submission experience
• Quantify number of dossiers or products managed
• Mention regulatory software exposure if applicable
• Emphasize query-handling and compliance achievements
• Keep resume structured with a separate Regulatory Experience section