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Experience: 15+ yrs

Location: Mumbai, Maharashtra, India

Job Type: Full-time

We are looking for a highly experienced Regulatory Affairs Specialist to lead and manage regulatory activities across the MENA (Middle East and North Africa) market. The role requires deep expertise in regional regulatory frameworks, product registrations, submissions, compliance, lifecycle management, and engagement with health authorities across multiple MENA markets.

The ideal candidate will bring extensive regulatory experience and a solid understanding of country-specific requirements, submission strategies, regulatory pathways, and market-entry considerations. You will play a key role in developing regulatory strategies that support successful product registration, approvals, launches, and continued market compliance.

Requirements

Key Responsibilities
- Develop and execute regulatory strategies for MENA markets in alignment with business and product objectives.




- Manage regulatory submissions, registrations, approvals, renewals, variations, and lifecycle activities across relevant MENA countries.
- Assess country-specific regulatory requirements and determine appropriate submission pathways and documentation requirements.
- Prepare, compile, review, and coordinate regulatory dossiers and submission packages.
- Ensure regulatory submissions are accurate, complete, compliant, and submitted within agreed timelines.
- Coordinate with regulatory authorities, local agents, distributors, consultants, and business partners across MENA markets.
- Respond to regulatory authority queries, deficiency letters, clarification requests, and follow-up questions.
- Monitor regulatory submissions and proactively manage timelines, dependencies, risks, and approval milestones.
- Support product launches by ensuring all applicable regulatory approvals, registrations, certificates, and documentati

📌 Regulatory Affairs Specialist (Mumbai)
🏢 Weekday AI
📍 Mumbai