Regulatory & Government Affairs Associate Job in Islamabad Pakistan

Regulatory & Government Affairs Associate Job in Islamabad Pakistan

Job Detail

• Regulatory & Government Affairs Associate

  • Designation: Regulatory & Government Affairs Associate

    Industry: Pharmaceutical                                                             

    Location: Islamabad

    Qualification: Bachelor’s degree preferably in Pharmacy or MBBS

    Experience: Minimum 2-5 years of Pharmaceutical experience in Regulatory Affairs and/or Quality Assurance. Regulatory Authorities (RA) or Drug Regulatory Affairs knowledge will be a plus.

    Responsibilities & Authorities:

    • Implementation & supervision of health authorities and regulations in the country
    • Ensures that current registration requirements are available, communicated and implemented
    • Compiles and submits registration files for new products
    • Follow-ups with the Ministry of Health on files review and ensures timely submission of additional documentation requested
    • Compiles and submits renewal files and updates of approved products
    • Ensures registration information system (RIMS) is updated according to the latest approved regulatory data in territory
    • Handles all labeling update processes and sends covering letters to Regulatory Operations.
    • Proof-reads labeling items and approves along with the local RA person
    • Support local RA in all the GMP, GDP, GXP and external inspection
    • Supports the local RA for authorization for distribution for imported shipment based on local regulations requirements

    Skills and Competencies:

    • Strong interpersonal & Communication skill
    • Strong Analytical & Decision making skills
    • Ability to work independently with least supervision
    • Excellent customer services and good IT skill
    • Understanding of Regulatory and Quality framework
    • High attention to details and accuracy.
    • High-quality cross-functional communication