Regulatory Executive API

Role & responsibilities

• Preparation of Drug Master File submissions and registration to relevant health
  authorities in e-  CTD/ ACTD/ NeeS format.  
• Submission of ASMFs with respect to different Marketing Authorisation Procedures (Decentralised  

Procedure, National Procedure, Centralized procedure) to European authorities.  

• Responses to the deficiencies received from different health authorities like EDQM, TGA, HSA  

SWISSMEDIC, NPRA etc. in accordance with the submitted ASMF.  

• Responses to the queries received from customers on applicants part of ASMF.  
• Preparation of Annual reports, notifications, renewals for maintaining the life cycle of the submitted  

DMF/ ASMF.  

• Timely analysis of regulatory changes and their impact on product and accordingly filing of self  

amendments, variations etc.  

• Preparation of LOAs, LOCs etc. with respect to submission of different Marketing authorisation  

procedures.  

• Review of technical documents such as Analytical method validation reports, Process validation  

reports, batch production records, drug development reports, stability data etc. pertaining to product  

registration.  

• Responsible for liaising between the different departments to receive necessary documents related  

to submission.  

• Compliance/ revision with country specific regulatory requirements.  
• Preparation of Facility Manufacturing Accreditation of manufacturing sites for Japan market.  

Technical Data Pack review for vendor approval.