Manager - Regulatory Affairs in Bombay, भारत

Manager in regulatory affairs leading product registrations, CMC strategy development, and cross-functional coordination for established pharmaceutical products. Manages complex regulatory submissions, maintains compliance throughout product lifecycle, and mentors junior team members.

Responsibilities

• Lead product registrations and prepare documentation packages for regulatory submissions
• Develop and communicate regulatory CMC strategies for assigned products and projects
• Represent regulatory position at project meetings and monitor compliance across product lifecycle
• Mentor junior team members and provide training on regulatory subject matter expertise
• Identify risks and coordinate with affiliates and cross-functional teams on regulatory activities

Requirements

• Bachelor's degree in pharmacy, biology, chemistry, pharmacology, or related field
• Minimum 10 years regulatory affairs, R&D, manufacturing, or related experience
• Specialist knowledge of regional and country-specific regulatory requirements
• Project management and cross-functional coordination capabilities
• CMC regulatory and technical scientific principles knowledge