Regulatory Affairs Analyst

• Preparation, review, and submission of variations (Type IA/IB/II), renewals, notifications, and administrative updates for global markets including EU, UK, and RoW markets etc.
• You will be responsible for preparation and review of Module 1 and CMC variation documentation
• You will be responsible for preparation of product information updates (SmPC, PIL, labels) and review of artworks to ensure regulatory compliance.
• Direct interaction with global regulatory authorities (EU NCAs, MHRA, other countries health authorities officials as applicable).
• Handling of post‑approval deficiencies/queries and providing timely responses to regulatory agencies.
• Providing regulatory guidance and regulatory strategies to CMO's and other cross‑functional teams for post‑approval changes.
• Support manufacturing sites during regulatory audits, inspections, and compliance‑related queries.
• You will be responsible for monitoring and follow‑up of product lifecycle submissions for early and timely approvals.
• You will be responsible for updating and maintaining regulatory databases, tracking tools, and submission logs.
• You will be responsible for participating in industry associations to keep abreast of global post‑approval regulatory requirements.

• 8 to 12 years of experience in regulatory affairs preferably in Europe Lifecycle management activities 
• Should have regulatory experience in lifecycle management activities for multiple markets especially in Europe
• Knowledge of EMA guidelines.
• Proficiency in spoken and written English
• Proficiency in using a computer and its applications, specifically Google Applications and MS Excel.

M.SC or M.pharm