Regulatory Affairs Executive - ROW Market

Emcure Pharmaceuticals Limited; Ahmedabad District; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Emcure Pharmaceuticals Limited is seeking an Executive/Officer in Regulatory Affairs - ROW Markets to prepare and compile regulatory dossiers for ROW, LATEM, CIS, Africa, and French West Africa regions. You will coordinate cross-functionally for CMC docs, review technical files, and ensure timely submissions to MOH and foreign clients.

With 3–8 years of experience and an M.Pharm, you will handle variation filings, artwork reviews, and plant-change controls to maintain regulatory compliance and

Qualifications

• 3–8 years of experience in regulatory affairs.
• M.Pharm qualification required.
• Working knowledge of regulatory submissions and lifecycle management.

Responsibilities

• Prepare and compile dossiers for ROW markets and regional groups.
• Submit responses to deficiencies noted by foreign clients and MOH within timelines.
• Coordinate with cross-functional teams for CMC and technical documents for regulatory submissions.
• Review CMC and technical documents such as MFR, PDR, specifications, BMR, BPR, PVR, AMV, stability protocols and data.
• Manage regulatory clearance processes for purchase orders, sharing approved artworks and specs with plants.
• Arrange samples, standards, and placebos for registration in various countries.
• Assess and review change controls of plant processes to ensure regulatory compliance.
• Review and approve artworks for registration and commercial products.
• Manage variation filings, post-approval activities, and product lifecycle maintenance.

Education

M.Pharm

Job description

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.