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.
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
Experience: 2-3 Yrs in DRA
Mail cv firstname.lastname@example.org