Regulatory Affairs Consultant

Description:

Lahore Pharma is seeking an experienced Regulatory Affairs Consultant to manage product registrations, renewals, licensing, regulatory compliance, and coordination with DRAP and relevant authorities.

Key Responsibilities

✅ Manage new product registrations, renewals, variations, and amendments with DRAP
✅ Prepare, review, and submit regulatory dossiers and supporting documents
✅ Maintain manufacturing, establishment, and other regulatory licences
✅ Monitor expiry dates and ensure timely renewals
✅ Liaise with DRAP, provincial drug authorities, and government departments
✅ Respond to regulatory queries, deficiency letters, and observations
✅ Review formulations, specifications, labels, packaging, and promotional claims
✅ Coordinate with QA, Production, Procurement, and Management
✅ Maintain updated records of registrations, pack sizes, compositions, and MRPs
✅ Support regulatory documentation for government and hospital tenders
✅ Arrange FSC, GMP certificates, product certificates, and other regulatory documents
✅ Support regulatory inspections and closure of observations
✅ Monitor changes in drug laws, DRAP regulations, and regulatory guidelines
✅ Advise management on regulatory risks before product launches or modifications

Required Qualifications & Experience

🎓 Pharm-D, B.Pharm, or relevant pharmaceutical qualification
🔹 Pharmacy Council of Pakistan registration preferred
🔹 Minimum 5 years of Regulatory Affairs experience in the pharmaceutical industry
🔹 Strong practical experience with DRAP and provincial drug authorities
🔹 Experience in manufacturing licences and product registrations
🔹 Good knowledge of Drugs Act, DRAP Act, Drug Registration Rules, GMP, and labelling requirements
🔹 Strong documentation, communication, and follow-up skills
🔹 Experience with external preparations, antiseptics, disinfectants, or OTC products will be preferred

Key Performance Indicators

📌 Timely registrations and renewals
📌 Reduction in regulatory objections and deficiencies
📌 Accurate regulatory records
📌 Timely resolution of DRAP queries
📌 Successful support for inspections and tenders
📌 Compliance of labels, packaging, and approved claims