Regulatory Officer

Job Summary

Responsible for regulatory activities related to the registration of pharmaceutical products, including preparation, compilation, submission, and follow-up of regulatory dossiers in compliance with applicable regulatory authority guidelines.

Key Responsibilities

• Development, compilation, and submission of Common Technical Document (CTD – Form 5F) for pharmaceutical product registration.
• Registration of pharmaceutical products for export purposes (Form 5).
• Handling e-application submissions to regulatory authorities.
• Preparation and submission of responses to regulatory queries and deficiencies within defined timelines.
• Ensuring compliance with local and international regulatory guidelines throughout the submission process.
• Coordination with internal departments (R&D, QA, QC, Production) to obtain required regulatory documentation.
• Maintenance of regulatory records, submission trackers, and product registration status.

Experience & Education

• Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related discipline.
• Minimum 2 years of experience in Regulatory Affairs within the pharmaceutical industry.
• Hands-on experience in CTD dossier preparation and regulatory submissions is required.
• Experience with export product registration is an advantage.

Skills

• Strong understanding of pharmaceutical regulatory requirements and guidelines.
• Expertise in CTD compilation and dossier management.
• Familiarity with electronic submission systems.
• Excellent documentation and organizational skills.
• Ability to manage multiple submissions and meet regulatory deadlines.
• Strong communication and coordination abilities.

Job Type: Full-time

Pay: Rs40,000.00 - Rs50,000.00 per month

Experience:

• regulatory in Pharma: 2 years (Required)

Work Location: In person