Leading Pharma Company Looking For Lead Ra


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HSR Layout, India
Job Detail
  • Industry:
    Pharma / Biotech / Clinical Research
  • Total Positions:
  • Job Type:
    Full Time
  • Salary:
  • Job Location:
    chennai, India
  • Minimum Education:
  • Minimum Experience:
    3 Years
  • Apply By:
    Sep 10, 2018
  • Job Posting Date:
    May 10, 2018
Job Description

Preparation of CTD/eCTD dossiers for various regulatory agencies.
Preparation & Review of SOPs related to Regulatory submissions.
Co-ordination with various departments like production, QA, QC, R&D for Regulatory documents. And preparation of documents for NOC, Test license, Import license and Manufacturing licenses
Review & Approval of specifications, STP to make in-line with USP, Ph.Eur.
Review & Approval of protocol and report as per Regulatory aspects (eg. Stability, Analytical method validation and etc.)
Preparation of database for various regulatory guidelines.
Maintaining matrix for different products as per the requirements of different Regulatory agencies 
Providing training on Regulatory requirements.
Responsible for submission activities (planning, authoring, reviewing, e-submission) for all markets
Preparation and review of Sterilization Assurance Package for Sterile Injectable and Ophthalmic products as per regulatory requirement. 
Responsible for submission of queries/deficiencies, post approval submissions and Annual Reports
Regulatory assessment and ensure requirements to avoid the RTRs
For product submissions, conduct project start-up/kick off meetings and document review meetings with the project team to confirm submission strategy and approach
To Identify the content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines 
Responsible for Effective implementation of eCTD software (PharmaReady), SPLs including ESG Gateway submissions. 
eview of all technical documents related to product submission as per Regulatory guidances (Eg. Stability, Analytical method validation etc.)
To comply with FDAs GDUFA requirements for the facility and ANDA submission.
Preparation of database for various regulatory guidelines.
Maintaining matrix for different products as per the requirements of different Regulatory agencies
Assessment of scope extension process for various markets 
Identifying regulatory risks and mitigations in change controls
Providing regulatory guidance/opinion in case of changes/deviations/new proposals

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