Officer / Senior Officer - Regulatory Affairs - #505312

Unichem Laboratories


Date: 1 week ago
City: Mumbai, MH
Contract type: Full time
Unichem Laboratories

RESPONSIBILITIES

  • Compilation of ANDA submissions in accordance with the latest guidances assuring technical congruency and regulatory compliance.
  • Identify the required documentation for EU regulatory submissions and compilation of MAA submissions for the EU in accordance with project timelines.
  • Review and identify content, and documents, related to dossiers compilation or query response.
  • Keep knowledge up to date about regulatory guidelines and requirements in all global regions as well as for new technical trends.
  • Respond to queries and issues received from regulatory authorities proactively.
  • Compilation and submission of CBE-0, CBE -30, labeling supplements, and annual reports and variation applications for EU.
  • Generation and submission of SPL for drug listing.

KEY SKILLS and COMPETENCIES

  • Must have hands-on experience in using eCTD software and attending e-publishing requirements throughout the project lifecycle
  • Should have handled original MAA submission for EU.
  • Good technical knowledge, review skills, and understanding of regulatory submissions
  • Strong knowledge of CTD /eCTD requirements for submission of dossiers.
  • Ability to try new approaches when faced with challenges.
  • Should have a good analytical and learning attitude.
  • Good communication (written and oral) and interpersonal skills.

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