To carry out Regulatory Review and Compilation of Technical documentation & dossiers as part of Life Cycle Management of products in compliance to applicable regulations and guidelines.

Job Description:

Duties & Responsibilities:

  • Providing high-quality CMC review of technical documentation i.e CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, Labelling documents, for regulatory filings in emerging markets, for DDReg clients
  • Review and/or compilation of (as per country-specific regulatory requirements) a. re-registration) dossier, b. variations
  • Carrying out all other regulatory activities pertaining to Life Cycle Management (LCM) of products in international markets.
  • Experience of EU, South Africa, and Australia/New Zealand preferred
  • Adequacy Review and Gap Analysis of documents for LCM purpose
  • Preparation of renewal & variation packages
  • Responses to deficiency letters.
  • Demonstrate subject matter and area expertise.
  • Effectively manage CMC projects to deliver quality projects in agreed timelines.
  • Collaborate with internal and external clients,
  • Supporting and enabling effective and efficient communication that results in operational excellence.
  • Demonstrate high-level of knowledge of country regulations and regulatory guidelines as updated from time to time on regulatory agency websites

Qualification: M.Pharma

Experience: 2-3 Yrs in DRA

Contact Details:

Source: https://ddreg.in/career/

Mail cv info@ddreg.in

hr@ddreg.in

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