This role is for one of Weekday’s clients
Salary range: Rs 2500000 - Rs 3500000 (ie INR 25 - 35 LPA)

Min Experience: 15+ years
Location: Mumbai
JobType: full time

We are seeking a highly experienced Senior Regulatory Affairs Specialist with 15–25 years of experience in regulatory affairs, with strong expertise in MENA markets and experience working across regulated markets. The ideal candidate will have a deep understanding of pharmaceutical, healthcare, medical device, or related regulatory frameworks and will be responsible for developing and executing regulatory strategies, managing submissions, ensuring compliance, and supporting market access across multiple geographies.

Requirements

Key Responsibilities
- Develop and execute regulatory strategies for product registrations, lifecycle management, variations, renewals, post-approval changes, and other regulatory activities across MENA markets.
- Manage end-to-end regulatory submissions and ensure that dossiers, supporting documents, labeling, packaging materials,



and technical information comply with applicable country-specific requirements.
- Serve as a key regulatory point of contact with health authorities and regulatory agencies across the Middle East and North Africa region.
- Monitor regulatory developments, guidelines, legislation, and changes in registration requirements across MENA and other regulated markets and assess their potential business impact.
- Coordinate with cross-functional teams including Quality, Medical Affairs, Clinical, Pharmacovigilance, Supply Chain, Manufacturing, Legal, and Commercial teams to ensure timely regulatory deliverables.
- Review and provide regulatory guidance on product development, manufacturing changes, labeling, promotional materials, and other business initiatives.
- Lead responses to regulatory authority queries, deficiency letters, requests for additional information, and other correspondence.
- Manage product renewals, variations, license maintenance, safety

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