Regulatory Affairs Officer

Position Summary

The Regulatory Officer is responsible for ensuring compliance with regulatory requirements for alternative medicines—including herbal, homeopathic, nutraceutical and other therapeutic goods—under the Health & OTC (HOTC) Division of DRAP. The role involves preparing and managing product registration dossiers, licensing documents, GMP certifications, and regulatory submissions while serving as a liaison between the organization and DRAP.

Key Responsibilities

• Prepare, compile, and submit product registration dossiers for herbal, homeopathic, nutraceutical, and Unani products in accordance with DRAP’s rules and formats.
• Ensure compliance with relevant rules such as:
• - S.R.O. 412(I)/2014 – Alternative Medicines Rules- GMP Guidelines for Herbal and Homeopathic Medicines
• Coordinate with DRAP for queries, evaluation letters, license renewals, product variations, and post-marketing surveillance requirements.

• Maintain regulatory files, tracking logs, and licensing documentation including:
• Establishment License (EL)- Product Registration Certificates- Free Sale Certificates (FSCs)
• Collaborate with cross-functional teams (Quality, Production, R&D, Marketing) to gather required documentation for regulatory compliance.
• Support inspections and audits by DRAP or third parties, and assist in GMP compliance and documentation updates.
• Monitor regulatory changes, new S.R.Os, guidelines, or notices issued by DRAP and communicate implications internally.
• Assist in submission of export registration files and compliance for international markets (e.g., GCC, Africa, South Asia) when required.

Required Qualifications & Skills:

Education: Pharm-D / B-Pharmacy from HEC-recognized institution.

Experience: 1–3 years of experience in regulatory affairs within the alternative medicine sector.

Knowledge:

- Strong understanding of DRAP's HOTC division requirements
- Familiarity with dossier formats, GMP documentation, and DRAP’s online portal (if applicable)

Skills:

• Excellent documentation and organizational skills
• Strong communication and correspondence writing (especially for DRAP queries)
• Attention to detail and understanding of regulatory language
• Proficient in Microsoft Office Suite (Word, Excel, Outlook)

Preferred Qualifications:

- Experience with licensing of new manufacturing sections (e.g., Homeopathic, Unani, Nutraceutical).

- Familiarity with submission of Free Sale Certificates and product dossiers for export.

- Prior interaction with DRAP inspectors and experience during GMP audits.

Core Competencies:

- Regulatory Compliance & Vigilance

- Dossier and Document Preparation

- Cross-Departmental Coordination

- Ethical Integrity & Professionalism

- Time and Task Management

Job Type: Full-time

Pay: Rs55,000.00 - Rs60,000.00 per month

Work Location: In person