BriefCase
BriefCase

Regulatory Affairs(experienced) -api/bulk Drugs Job in Hetero Drugs Limited

Regulatory Affairs(experienced) -api/bulk Drugs

Hetero Drugs Limited 4+ weeks ago
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Job Summary
  • Drafting the CMC part of regulatory DMFs and dossiers for marketed products for world-wide submissions in CTD module.
  • Compiled, reviewed, published, and submitted USDMFs and dossiers in CTD format in accordance with regulatory requirements for eCTD submission.
  • Markets include US, EDQM, ROW, and Canada.
  • Solving queries and following guidelines such as ICH, WHO, EMA, USFDA and CDSCO.
  • Reviewing Specifications, Validation documents, BMR and SOP's.
  • Timely prepared Registration / Renewal Dossiers to various countries for Pharmaceuticals API in e-CTD format.
  • Preparing and reviewing Quality Assurance and Regulatory SOPs
  • Reviewed, published, validated and submitted dossiers in CTD and eCTD format in accordance with regulatory requirements for submission.
  • Reviewing, analysing and interpreting the analytical reports, batch records, COAs, stability reports, validation protocols and reports for API.
  • Responding to queries from Regulatory authorities and customer service department. Working with honesty and true diligence with people with diverse cultures, to keep up the team spirit.
  • Created and maintained all Regulatory Database systems in accurate and timely manner. Working with enthusiasm and flexibility to meet deadlines, used people skills and communication skills to achieve goals faster.
  • Ability to partner successfully with Senior Leaders in the organization, quickly building trust and credibility by setting a high visible example of professional excellence.
  • Monitoring Developmental QA activities,
  • Responsible for review, approve and submit Technology transfer documents generated during new product development.
  • Responsible for review and support of Technical documents submission to Regulatory authorities.
  • Strong influencing skills, ability to lead work in a virtual and multi-cultural environment, Complex project management leadership skills and problem solving approach.
  • Lead technical support and cooperation with the Marketing Dept. to support customer needs.
  • Reviewing and assessing change control packages to determine filing category, regulatory filing strategy for various markets. Meeting timelines to ensure prompt approvals and kept business update for faster approval and implementation of the change.
  • Performing Risk-benefit analysis for regulatory compliance.Roles and Responsibilities
Experience Required :

3 to 7 Years

Vacancy :

2 - 4 Hires

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