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Plant Regulatory Affairs - India  

Dr.Reddy's (company)


Posted on : 08 March 2017

Project Description


 Key Responsibilities: 
Change Control Evaluation & Document Review 
  • Review various CMC changes taking place at site, check the adequacy of supporting data and approve / reject the change proposals; 
  • handle CIPs / QIPs / Scale-up changes &  KSM / intermediate source changes and then chalk out a regulatory strategy for the DMF submission IN ORDER TO meet the RA change control guidelines and ensure a proper regulatory strategy for DMF submission


Documentation
  • Review all the documentation for submission to Corporate RA team for preparing DMFs / open parts  of  commercial products; 
  • ensure that all the amended documentation generated subsequent to the approval of changes is  submitted to the Corporate RA team for subsequent DMF amendment / update submission;
  •  Review the deficiency letters, arrange meetings with the respective CTO teams and submit  all the necessary amended documentation to Corporate RA  team for preparing the responses;  
  • Support the Corporate RA (license team) for  local licensing (DCA/DCGI) requirements IN ORDER TO ensure the timely submission & approval through agencies


Regulatory Compliance
  • Ensure compliance to the Pharmacopoeial updates that appear in the USP, EP, BP, JP Pharmacopoeia, Forum & Supplements; 
  • Ensure that the regulatory /customer commitments and notifications are met; 
  • Ensure that the queries from Regulatory Agencies or Customers on the Regulatory submissions are responded within the predefined timelines, with adequacy and accuracy IN ORDER to meet regulatory compliance and the customer's requirements


Support During the Regulatory Audits
  • Enable the audits by acting as a SPOC  , provide regulatory support/data  to plant cross functional teams (CFT) for audits by the regulatory authorities / agencies; 
  • Involve and provide regulatory support to plant CFT regarding OOS / OOT / Other Product related issues / plant related activities IN ORDER TO ensure no NC during the regulatory audits.


Regulatory Knowledge Sharing
  • Communicate the new/updated/revised guidelines to the CFT on a need basis & ensure that the teams are aware about the latest updates; 
  • Provide the regulatory training to the respective CTO teams IN ORDER TO ensure compliance to regulatory requirements at all times


Operating Network: 
Internal: Plant QA, Plant QC, Production Team, ESD team, Corporate RA team
External: Customers, Regulatory Authorities
 

 Technical Requirements: 
Basic understanding of the pharma business
 

Educational & Experience
 M. Sc. (Chemistry) with 8 to 10 years of industrial experience in the area of RA



Key Attributes: 
  • Understanding of various ICH / EMEA / FDA /PMDA guidelines, 
  • Technical writing skills, 
  • Good training skills, 
  • Strong analysis and data mining skills
  • Excellent Communication skills (with a structured approach to every activity), 
  • Networking skills (for coordination and collaboration across multiple functional teams, 
  • organizational activities)
  • Time management and work prioritization ability, 
  • Self-starter (should be able to work independently with minimal supervision).



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