Regulatory Affairs Specialist-Pakistan

Key Responsibilities:

* DRAP registration of IVD kits and analyzers

* Renewal, variation, and post registration submissions

* Review of IFU, labels, and artwork

* Response to DRAP observations and regulatory correspondence

* Any other work arranged by management

Requirements:

1.Education (HEC recognized):

* Doctor of Pharmacy (Pharm D)

* Bachelor of Pharmacy (B Pharm)

* MPhil in Medical Sciences, Biochemistry, or Pharmaceutical Sciences

2.Professional Registration:

* Valid Pharmacy Council registration (mandatory for Pharm D and B Pharm)

3.Experience:

* Minimum 3 years experience in regulatory affairs

* Hands on experience with IVD, immunoassay, and clinical chemistry product portfolios, including diagnostic kits, analyzers, and reagents

4.Skills:

* Strong knowledge of DRAP IVD regulations

* Good written English and documentation skills

* Ability to manage multiple registrations independently

Work location:

Islamabad (Close coordination with DRAP HQ)