Regulatory Affairs Executive - ROW Market

Experience: 3 to 8 years

Designation: Executive / Officer

Department: Regulatory Affairs - ROW Markets

Qualification: M.Pharm

Job Location: Ahmedabad

Job Details mentioned below

• Preparation and compilation of dossiers for ROW, LATEM, CIS (Kazakhstan, Ukraine, Uzbekistan), Africa (South Africa, Tanzania, Kenya, Uganda, Zazibona) & French West Africa (Ivory Coast, Benin, Mali, Togo) regions as per the country specific regulatory requirements.
• Preparation and submission of responses to deficiencies and observations received from the foreign clients and MOH of respective countries within the given timeline.
• Co-ordination with cross-functional teams for collection, review and compilation of CMC and other technical documents required for regulatory submissions, ensuring alignment with applicable regulatory requirements.
• Review of CMC and technical documents such as MFR, PDR, Specification, BMR, BPR, PVR, AMV, Stability Study Protocol & Data as part of dossier preparation and submission activities.
• Handling the regulatory clearance process of Purchase Orders of registered products by timely sharing the approved artworks, specification and other technical documents to Plant in order to maintain the business continuity.
• Arranging the finished product samples, standards, placebos from Plant and sending them to various countries for registration purpose.
• Assessment & Review of Change Controls of Plant ensuring the compliance with regulatory requirements.
• Review and approval of artworks for registration purpose as well as for commercial products.
• Managing the Variation filing /Post-approval activities and maintaining the product lifecycle management.