Job Description:

1) Should be able to handle the international Regulatory Affairs (Formulations) for filing of DMFs / CTDs to various Regulatory bodies  viz. Aus / Europe market.
2) Should have experience in formulations – steriles and other dosage forms.
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.

Candidate Profile:

1) Ph.D/M.Sc, Diploma in Regulatory affairs with 10 to 15 yrs of relevant experience.

Location: Bangalore

Opportunity ID: SPH-REG12012

Contact Person : Meenu - 080-65681003

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