Rajan Babu Ramadoss

About Rajan Babu Ramadoss

I am currently holding a professional pharma degree with masters in clinical Research and Regulatory Affairs. Having nearly 18 years of experience in Regulatory CMC authoring, module 3 documentations, module 2 authoring, submission and publishing into various markets like USFDA, EMA, LATAM, Health Canada, Chinese NMPA and Japan PMDA. Interacting and responding health authority queries, hands on experience in eCTD, ACTD,NeeS and Paper format. ANDA, IND, NDA, DMF, with FDA, Marketing Authorizations, Variations and renewals and CEP applications with EMA and EDQM, Lifecycle management operations with health Canada, GMP clarance with TGA, RIMS and GDMS are added advantages. Liasioning with CDSCO and State Drug Control Authorities for Mfg license renewals, new endorsement, GMP revalidations and written confirmation applications and it’s due deligence are additional job responsibilities. Project management and people management with customer sataisfations are my day to day operations. I am currently working as a manager Regulatory Affairs CMC and looking for a good opportunity with work life balance. Message to recruiters: looking for some how leadership position. Location is not a constraint.#cmc #regulatoryaffairs #dossier #submissionmanagement #cdsco #gmp #qualitymanagementsystem #anda #ind #nda #dmf #lcm #usfda #latam #nmpa #pmda #healthcanada #projectmanagement #peoplemanagement #regulatoryaudit #customersatisfication #worklifebalance #jobopportunity #regulatorycompliance #rims #gdms #healthautorityquery #variations #marketingauthorizationapplication #renewals #postapprovalsubmissions #pre notification

Experience

1. Senior Manager Regulatory Affairs

   Sekhmet Pharmaventures

   Apr 2023 — Present · Chennai, IN

Education

• The TamilNadu Dr.M.G.R Medical University

  Bachelor's degree

  1999 — 2003

• CQI IRCA

  Lead auditor QMS

• Sikkim Manipal University - Distance Education

  Master of Science (MSc)

  2010 — 2014