I’m specialized in Keeping close track to Regulatory changes and interpreting its implications on the Drug Development process to get marketing authorizations and the understanding of the technicality involved in Regulatory Submissions.I’m able to synthesize complex information and convert it in a comprehensible manner especially during project team meeting. I can prepare, write and review all types of regulatory documentation with regards to quality, safety, and efficacy. While most regulatory documents are highly structured templates, which requires a certain number of linguistic skills to combine subject matter knowledge and information from a spectrum of regulatory guidelines in order to come up with a document that is in compliance with regulations.Email: balakrishnachilukuri@gmail.com