Regulatory Affairs Manager

Description

• Experience in handling large global regulatory programs
• Review and Finalization of Change Control Impact assessment and global variation submission strategy
• Peer review and guidance on post approval submission packages
• Experience with end to end regulatory activities for global countries like, Europe, APAC, Africa, MENA, LATAM...
• Tracking of post approval and Renewal submissions plan and ensure timelines
• Lead the CFT meetings and coordination with all stake holders for timely completion
• Submission strategy and guidance on country specific requirements for market expansions
• Strategic guidance and review support in handling of responses to HAQs
• Excellent communication and collaboration skills
• Team management and leadership skills
• Experience in handling global stake holders
• Experience in handling all domains of end to end registration activities
• Create positive team environment and client relations
• Business Acumen
• Ability in innovative thinking and problem solving