Hyderabad; MPharm; Regulatory Affairs Professionals; Dr Reddy's

Desired Candidate Profile

• M.Pharma Experience:• 4-7 years of experience in R&D or RA
Job Description
· Perform as per regulatory filing plan through interaction with Formulations Head.
· Ensure that the regulatory submissions are made in time, according to the guidelines of various agencies.
· Ensure the regulatory submissions are adequate and error free, with minimum open issues.
· Close these open issues before filing if possible.
· Provide inputs/guidance to the PDTs.
· Review the documents received from R&D, DQA, AR&D, etc. at each and every stage of formulation development so that the same can be shared with authorities and customers.
· Respond to FDA queries in consultation with Critical Task Force team.
· Ensure that the queries from Regulatory authorities or the customers are responded within pre defined time, with adequacy and accuracy.
· Review the process change proposals and provide guidance on change proposals.