Regulatory Affairs Officer

Department: Regulatory Affairs
Reports To: Regulatory Affairs Manager / Head of Quality & Compliance
Location: Ahsanabad Phase 1, Super Highway Industrial Area

We are hiring on behalf of our client, a Regulatory Affairs Officer who will be responsible for ensuring that the company’s manufacturing operations, products, and documentation comply with all applicable regulations of the Drug Regulatory Authority of Pakistan (DRAP) and other relevant regulatory bodies. The role supports product registrations, renewals, variations, licensing, and ongoing regulatory compliance throughout the product lifecycle.

Key Responsibilities

• Prepare, compile, submit, and track regulatory dossiers to DRAP for product registration, renewals, variations, and amendments.
• Liaise with DRAP officials regarding queries, inspections, approvals, and regulatory correspondence.
• Ensure compliance with DRAP Act, Rules, SROs, guidelines, and applicable pharmacopeial requirements.
• Maintain up-to-date regulatory files, licenses, registrations, and approvals for all products and manufacturing facilities.
• Coordinate with Quality Assurance, Production, R&D, and Supply Chain departments to collect required technical and regulatory data.
• Support site inspections, audits, and compliance activities conducted by DRAP or other authorities.
• Monitor changes in DRAP regulations and communicate regulatory updates to relevant departments.
• Assist in preparation and review of labeling, packaging, inserts, and promotional materials for regulatory compliance.
• Maintain proper documentation and records in accordance with DRAP and GMP requirements.
• Perform other regulatory-related duties as assigned by management.

Reporting & Authority

• Reports directly to the Regulatory Affairs Manager or designated senior management.
• Has no direct supervisory authority unless assigned.

Qualifications

• Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related discipline.
• Prior experience in regulatory affairs within a DRAP-regulated pharmaceutical or manufacturing environment is preferred.
• Fresh graduates with strong regulatory knowledge may be considered.
• Familiarity with DRAP submission processes, CTD format, and regulatory documentation is an advantage.

Skills & Competencies

• Strong understanding of DRAP regulations and pharmaceutical regulatory requirements
• Attention to detail and strong documentation skills
• Effective written and verbal communication
• Ability to coordinate with cross-functional teams
• Time management and ability to meet regulatory deadlines
• Professional ethics and confidentiality

Working Conditions

• Office-based role with occasional visits to manufacturing, quality, or warehouse areas.
• May require interaction with regulatory authorities and attendance during inspections or audits.

Job Type: Full-time

Pay: Rs90,000.00 - Rs100,000.00 per month

Work Location: In person