Team Member - LCM

Division

Department

Employment Type

Job Purpose

Implement Life cycle management activities for Non-respi products (for US, EU, South Africa, ANZ, WHO, PEPFAR & 150+ countries ) to have Business continuity

Accountabilities

I. Assess change request across the globe allocated by GL to review, evaluate and categorize the change as per regulatory guidelines to meet launches, commercial needs and compliance
II. Prepare variation packages for modules 2 to 5 and deficiency response across the globe to support commercial launches, on-going commercial and regulatory compliance.
III. Prepare annual report (US) as per schedule to meet regulatory compliance for business continuity.
Prepare WHO requalification dossier to maintain product licence for business continuity.
IV. Compile re-registration dossier to maintain product licence for business continuity.
V. Maintain and update product database for easy retrieval and status tracking

Education Qualification

Minimum Graduate in Pharmacy or Life Sciences

Relevant Work Experience

5 years in the field of Regulatory Affairs/ Quality Assurance/ Quality control/ Manufacturing/ Analytical Development/ R&D

Competencies/Skills

Job Location

Vikhroli

Shift Hours