Job Description:

1) Should be able to handle the international Regulatory Affairs (API) for filing of DMs / CTDs to various Regulatory bodies  Viz. USDMF,EDMF,CEP EDQM, TGA, TPD-canada, MCC, South Africa, Brazil etc.

2) Sound knowledge of current regulatory guidelines.

3) Preparation of DMFs amendments / annual updates/ variation filings.

4) Preparing Scientific responses to customer and Regulatory queries

5) Acquaintance with e-CTD filings.

6) Excellent communication and interpersonal relations skills.

7) Should have worked for reputed organizations at least for a period of 5 years.

Candidate Profile:

1) Ph.D/M.Sc, Diploma in Regulatory affairs with 12 to 17 yrs of relevant experience

Location: Hyderabad

Opportunity ID: SPH-REG12010

Contact Person : Meenu Krishna - 080-65681003

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