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Summary:
Under limited supervision responsible for the implementation of global regulatory strategies, obtain and maintain marketing authorizations for product(s) and communication of general regulatory requirements in support of licensing of Baxter’s products.



Support regulatory activities relating to specific portfolio of global products/projects.
Essential Duties and Responsibilities:
With direction, develop and execute regulatory project plans
Identify and elevate key areas of regulatory risk
Maintain regulatory files in a format consistent with requirements
Maintain awareness of regulatory requirements; identify relevant requirements
Participate as an active team member and provide regulatory advice to project teams as required
Respond to questions from regulatory authorities within strict timelines
Compile and submit, in a timely manner, regulatory documents according to regulatory requirements
Maintain and update existing regulatory authorizations
Support regulatory activities relating to specific portfolio of products/projects
Prepare, review, and approve labeling and SOP’s
Represent or lead Regulatory Affairs in small project teams
Qualifications:
Knowledge of regulations
Scientific knowledge
Proje

📌 Senior Specialist (Ahmedabad)
🏢 Baxter International
📍 Ahmedabad