srinivasa rao

"Regulatory Affairs Certified (RAC - Global)" professional with 13+ years of working experience in the pharmaceutical industry, demonstrated analytical and communication skills that encompass identifying critical concepts, solving complex problems, presenting complex ideas in a clear, concise and persuasive manner and keen attention to detail.
Ability in effectively managing time and multiple projects, co-ordination with customers and distributors to get the product registration in ASEAN, Hong Kong, Taiwan, Korea & Middle East countries.
Expertise in performing dossier health check for in licensing projects, providing regulatory strategies to get quick registrations in SEA countries, liaisons with health authorities and updating knowledge on regulatory guidance. 
Successfully prepared plant registration files and was approved in Middle East countries & Cambodia.
Have productively prepared dossiers & responses for following Regions: Eastern Europe, CIS countries, ASEAN Countries, GCC countries, Latin America, Central America, and African Countries.

Heading Regulatory department and responsible for In-licensing submissions across SEA countries, reporting to CEO
Performing regulatory due diligence for all in-licensing dossiers, identify potential issues which may affect the quality of the documentation or submission timelines
Coordinating with 10+ manufacturers, authoring and reviewing CMC documents/ancillary documents to make ready for submission dossiers within the target timelines
Anticipating list of queries, proactively working with manufacturing sites to make the documentation available to meet the query response timelines. 
Establishing regulatory procedures and sharing required regulatory information to the cross functional teams.

Masters in Pharmacy

RAC by RAPS USA