Assistant Manager, Regulatory Sciences (Evergreen Position) in Bombay, भारत

Assistant Manager, Regulatory Sciences at Pfizer responsible for developing and executing regulatory strategies for product marketing authorizations and clinical trial approvals across India and select Asian markets. The role involves managing national regulatory submissions, liaising with authorities, and providing cross-functional regulatory guidance to support business objectives.

Responsibilities

• Develop and deliver regulatory strategies for licensed and development products across assigned territories
• Coordinate pre-submission meetings and manage interactions with national regulatory authorities
• Handle marketing authorization variation applications and renewal filings
• Respond to regulatory authority queries and provide strategic regulatory advice to cross-functional teams
• Maintain regulatory databases and support clinical trial authorization activities

Requirements

• Expert knowledge of national pharmaceutical legislation, guidelines, and regulatory environments
• Experience managing marketing authorization applications and regulatory submissions
• Strong cross-functional collaboration and stakeholder communication skills
• Ability to develop regulatory strategies aligned with business goals
• Knowledge of clinical trial authorization processes and requirements