Tuesday, 11 September 2018

MSN Laboratories Pvt Ltd Openings For API Regulator Walkin Drive 15th September 2018

Name of Organization Or Company Name :MSN Laboratories Pvt Ltd

Job Role Or Post Name:API Regulator

Educational Qualification:Any Graduate

Experience: 1-8 Years

Job Location:Hyderabad

Job Description:

  • API Regulatory Affairs .in API Division- R&D Center. API RA . . in API Division-R&D Center.
  • Regulatory Affairs API RA Dept and in API Division, Job Description: ( Regulatory Affairs – API Division )
  • Should have a minimum of 1 to 8 years of experience in API Regulatory Affairs
  • Thorough knowledge in the US, EU, and CA regions DMF submission procedures along with the emerging markets such as Brazil, Taiwan, Japan, Russia, China, etc
  • Should possess good response drafting skills to ensure that the responses to the regulatory queries are adequately addressed
  • Should have knowledge and experience in an eCTD submissions to US, CA and EU and troubleshooting the issues
  • A thorough review of regulatory submissions prepared by team members and to ensure the correctness of the documents or submissions.
  • Responsible for ensuring and sending the response to all the technical queries received from various customers are appropriately responded as soon as possible.
  • Conducting meetings for the deficiency letters received from various regulatory authorities and also tracking of deficiencies concerning the target timelines and ensure that the response is sent to the authorities as per the stipulated deadlines.
  • Participation in the Cross Functional Team (CFT) with meetings and guidance to the product development team on regulatory issues.
  • Participation in the Technology Transfer Meetings and ensure that the product is meeting the regulatory requirements.
  • Responsible for ensuring that the regulatory database is properly maintained and update.
  • Responsible for Review and approval of change control and should ensure that all the approved changes are reported to the regulatory authorities. Drug Regulatory Affairs API RA Dept.

Document Required:

  • All educational marks memos from schooling.
  • Latest passport photocopies.
  • Hard copies of an updated resume.
  • Any ID Proof such as Aadhar Card, PAN Card, Licence, Passport, etc.

Venue:Walkin Date: 15th September 2018

Walkin Time: From 9.00 AM to 1.00 PM
MSN Laboratories Pvt.Ltd.,

R&D Center, Pashamylaram


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