ROLE
– Prepare, Review and Finalize Regulatory strategies for Complex Products
– Draft, Review and Finalize Pre-ANDA/Pre-IND/ScA meeting packages for US and EU market
– Draft and finalize controlled correspondences on complex issues
– Review API and FP in-vitro characterization/sameness reports
– DMF review for complex APIs as per the workflow
– Collaborate and work closely with cross functional teams
– Meet the management expectations w.r.t timelines and quality
– Work closely within the team and provide training to new members on new regulatory requirements for Complex products

BENEFITS
– No benefits or perks mentioned