
Senior Officer Regulatory Affairs
2 weeks ago
Major Responsibilities
- Prepare, review, and submit regulatory documents, including Clinical Trial Applications (CTAs), Investigational New Drug (IND) applications, and protocol amendments.
- Ensure compliance with ICH-GCP, FDA, EMA, WHO, and local regulatory guidelines for clinical trials.
- Maintain up-to-date knowledge of regulatory requirements and communicate changes in the regulatory requirements to internal teams.
- Act as the primary point of contact with regulatory agencies, central/national ethics committees, and institutional review boards (IRBs).
- Coordinate responses to regulatory queries and deficiencies to ensure timely approvals.
- Maintain regulatory files, study-specific documents, and trial master files (TMF) in compliance with SOPs and GCP guidelines for regulatory correspondence.
- Assist in the development, review, and revision of regulatory Standard Operating Procedures (SOPs).
- Ensure that all clinical trial approvals, amendments, and safety reports are accurately documented and archived.
- Support regulatory submissions related to Investigational Medicinal Products (IMP), including labeling, import/export licenses, and distribution approvals.
- Monitor and submit Adverse Event listings and Serious Adverse Event (SAE) reports to regulatory authorities as per reporting timelines.
- Participate in internal audits, inspections, and regulatory readiness programs.
- Work closely with clinical operations, quality assurance, data management, and sponsors to ensure regulatory compliance throughout the trial lifecycle.
- Support business development teams by providing regulatory insights for proposals and feasibility studies.
Job Type: Full-time
Pay: From Rs75,000.00 per month
Work Location: In person
-
Regulatory Affairs Officer
2 weeks ago
Lahore, Punjab, Pakistan Neutro Pharma (Pvt.) Ltd Full time $40,000 - $80,000 per yearCompany DescriptionEstablished in 2002, Neutro Pharma is dedicated to the betterment of mankind through advanced healthcare solutions. Known for its pioneering efforts in marketing therapeutic nutritional products in Pakistan, the company is highly regarded by the medical community. Over the years, Neutro Pharma has engaged in extensive research, evolving...
-
Officer Regulatory Affairs
2 weeks ago
Lahore, Punjab, Pakistan Remington Pharmaceutical Industries (Pvt.) Ltd. Full time 486,000 per yearOfficer Regulatory AffairsEducationPharm-DExperience06 months - 01 yearRequisites for the Role· Time Management· Team work· Problem Solving· Good Communication· DiligenceAreas of Responsibilities· Collect, Evaluate, Organize and Manage Documents.· Responsible for compilation of Dossier.· Mapping of the documents with changes in Regulatory...
-
Regulatory Affairs Officer
4 days ago
Lahore, Punjab, Pakistan remington pharma Full time 300,000 - 600,000 per yearResponsibilitiesPrepare and submit CTD / ACTD dossiers for international markets, handle queries and follow up till registration.Ensure that all product registrations and submissions comply with applicable laws, guidelines, and industry standards.Prepare other supporting regulatory documents as required by foreign regulatory agencies.Collaborate with QA, QC,...
-
Regulatory Affairs Professional Leader
5 days ago
Lahore, Punjab, Pakistan beBeeRegulatoryAffairs Full time 5,000,000 - 10,000,000Job OverviewElevate Your Career with a Leadership Role as we seek an Assistant Manager Regulatory Affairs professional to drive regulatory compliance excellence.Key Responsibilities:Regulatory Compliance ManagementDevelop and implement effective regulatory strategiesEnsure compliance with relevant laws and regulationsMaintain accurate records and...
-
Manager Administration And Regulatory Affairs
2 weeks ago
Lahore, Punjab, Pakistan Akbari Group Full time 600,000 - 1,200,000 per yearCompany DescriptionAkbari Chemical Industries Private Limited (ACI) was established in 1979 with a vision to produce quality industrial chemicals and support the nation's export potential. Since its inception, ACI has significantly expanded its product range, which now includes Formic Acid, Aluminium Sulphate, Sodium Sulphate, Single Super Phosphate (SSP),...
-
Assistant Manager Regulatory Affairs
1 week ago
Lahore, Punjab, Pakistan Servier Pakistan Full time 104,000 - 130,878 per yearDate posted: Jul 17, 2025City: LahoreCountry/Region: PKType of Contract: Full-time Employment / UnlimitedJob Requisition ID: 8812Assistant Manager Regulatory AffairsElevate Your Career with Servier PakistanActivities & Responsibilities:Drug Regulatory Authority of Pakistan (DRAP)To develop and maintain close liaison with all offices and branches of Drug...
-
Assistant Manager Regulatory Affairs
6 days ago
Lahore, Punjab, Pakistan Servier Pakistan Full timeOverviewDate posted: Sep 13, 2025City: LahoreCountry/Region: PKType of Contract: Full-time Employment / UnlimitedJob Requisition ID: 8812Assistant Manager Regulatory AffairsElevate Your Career with Servier PakistanResponsibilitiesActivities & Responsibilities: Drug Regulatory Authority of Pakistan (DRAP)To develop and maintain close liaison with all offices...
-
Regulatory Executive
3 weeks ago
Lahore, Punjab, Pakistan Evyol Group Full timeCompany DescriptionEvyol Group is a rapidly growing conglomerate engaged in the sales, services, and distribution of high-quality pesticides, seeds, high-efficiency irrigation systems, and urban pest solutions. With a "Customer Driven" ideology, Evyol has significantly influenced Pakistan's agriculture market by introducing innovative technologies and...
-
Assistant Manager Regulatory Affairs
7 days ago
Lahore, Punjab, Pakistan Servier Group Full timeSelect how often (in days) to receive an alert:Type of Contract: Full-time Employment / UnlimitedJob Requisition ID: 8812Assistant Manager Regulatory AffairsElevate Your Career with Servier PakistanActivities & Responsibilities:Drug Regulatory Authority of Pakistan (DRAP)To develop and maintain close liaison with all offices and branches of Drug Regulatory...
-
Regulatory Specialist
2 weeks ago
Lahore, Punjab, Pakistan Evyol Group Full time 600,000 - 1,200,000 per yearCompany DescriptionEvyol Group is a rapidly growing conglomerate engaged in the sales, services, and distribution of high-quality pesticides, seeds, high-efficiency irrigation systems, and urban pest solutions. With a "Customer Driven" ideology, Evyol has significantly influenced Pakistan's agriculture market by introducing innovative technologies and...