Executive/Sr Executive Regulatory Affairs(CIS Market)

About Jodas Expoim

Jodas Expoim Pvt. Ltd. is a fast-growing, innovation-driven pharmaceutical company focused on providing high-quality, affordable medicines across global markets. We specialize in injectables, oncology, and critical care products and have a strong presence in CIS, RoW, and emerging markets.

Job Purpose

To support regulatory activities for dossier preparation, submission, CIS (Commonwealth of Independent States) market, ensuring timely product registration and compliance with regional regulatory requirements.

Key Responsibilities

• Prepare, review, and compile CTD / ACTD dossiers for CIS countries.
• Coordinate with cross-functional teams (R&D, QA, QC, Production, Packaging, etc.) for data collection and documentation.
• Handle registration submissions, responses to queries, and life-cycle management of registered products.
• Maintain regulatory databases and track submission status and approvals.
• Review artwork, labeling, and packaging components for regulatory compliance.
• Support post-approval variations, renewals, and amendments.
• Liaise with external regulatory consultants, partners, or distributors for dossier submissions.
• Stay updated with country-specific regulatory guidelines and changes.

Required Skills and Qualifications

• Education:

  M.Pharm / B.Pharm / M.Sc in Pharmaceutical Sciences or related field.

• Experience:

  15 years in Regulatory Affairs (preferably in CIS / RoW markets).
• Strong understanding of CTD / ACTD formats and regulatory documentation.
• Good knowledge of international regulatory guidelines and submission requirements.
• Excellent communication and coordination skills.
• Detail-oriented with strong analytical and organizational abilities.
• Proficiency in MS Office and document management systems.