Team Member Mulation Tech Transfer Job Openings in Gangtok, Sikkim - Cipla Limited Recruitment 2018

Overview

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Cipla Limited Job Vacancies 2018

Team Member mulation Tech Transfer Job Openings in Gangtok Sikkim

Team Member Regulatory Affairs India

Job Purpose:
To prepare the dossiers within stipulated timeline to achieve the target for FSSAI related submissions, local and export submissions to DCGI

Key Accountabilities:
Accountability Cluster
I.Collate the data required for Registration or Dossier submission to Regulatory authority for Local market and Export purpose

Major Activities / Tasks

  • Collation of data required for submission
  • Preliminary review of data
  • Follow up with stakeholders for deficient data
  • Compilation of documents as per checklists
  • Literature search
  • Communicate to liasoning team for submission to regulatory authority
  • Receipt of approval & cascading to relevant team members
II. Submit the query response expected by authority within standard timelines to get the approval
  • Preparation of documents (Declarations, undertakings, covering letters etc) for query response submission
  • Collate the data needed for query response from different team members
  • Online query response
  • Intimation to other team members in case of anticipated queries & preparation for respective responses
III.Align stakeholders for regulatory guidelines pertaining to DCGI & FSSAI and Interact with Regulatory Authority through counterpart in DCGI for better understanding of path to be followed for future projects
  • Alignment and daily interaction with different team members for explaining regulatory guidelines
  • Interaction with counterpart in Delhi office for understanding the path to be followed for future projects & documents needed for the same.
IV.Submit the SAE and PSUR reports to DCGI within stipulated timelines and get the acknowledgement

  • Acknowledge the receipt of cases/PSURs sent by Drug Safety Department
A.Cases from Spontaneous sources, Literature
B.Clinical trial case reports
C.PSURs (Periodic, ad-hoc)
  • Communicate to liasoning team for submission to DCGI within the required timelines
  • Receive the acknowledgement from DCG(I)
  • Send it to Drug Safety Department for record purpose
  • Maintenance of hard copies of acknowledgements
V.Assess the commercial launch related activities & complete the licencing related activities before launch for Consumer Healthcare Division of Cipla Health Limited (Weekly and need based meetings for example- Dossier review meeting)

  • Online licence application & query response
  • Weekly Dossier review meeting with stakeholders & other need based meetings
  • Preparation of its Agenda and minutes of the meeting & subsequent tracking of all activities (data collation)
  • Physical submissions in coordination with consultant for commercial launch
VI.During artwork finalization for CHC products

  • Checking content of artwork & providing clearance on regulatory point of view for commercial launch
VII.Perform end to end database management activities in order to ensure correct and up to date data is available for team for preparation of monthly reports

  • Daily updation of online trackers/ database
  • Maintenance of hardcopies of acknowledgements, approvals, query letters of DCGI & FSSAI submissions
Educational qualifications:
B. Pharm, Graduate/Post Graduate in Life Sciences

Relevant experience:
Experience in handling India regulatory for at least 1-5 years. Should have handled registration and post registration activities including life cycle management

As one of the leading company in United State, Cipla Limited offers variety of opportunities for employees to grow and make them as future leaders of the professional and disciplined. Cipla Limited also gives a dynamic work environment in order to encourage employees to contribute optimally, and at the same time is able to upgrade new experience and knowledge through the company programs.

If Mr interested to registrate Team Member mulation Tech Transfer Gangtok Sikkim May 2018 Cipla Limited Cipla Limited, immediately prepare requirements / files and documents needed for apply Team Member mulation Tech Transfer Gangtok Sikkim May 2018 Cipla Limited above. To apply by online, please click the "Apply" button below. If you still do not satisfy with our job recruitment information above, you can try to read other job recruitment information that we provide in our website which still located in Gangtok Sikkim region from any other company.

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