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Regulatory Affairs Executive /Assistant Manager

Regulatory Affairs Executive /Assistant Manager

Aura Lifecare

4 - 8 years

4 - 9 Lacs

Vadodara/ Baroda

Posted:2 months ago| Platform:

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Skills Required

ctd Regulatory Affairs Dossier Preparation Ectd

Work Mode

Work from Office

Job Type

Full Time

Job Description

Dossier preparation as per CTD/ACTD/eCTD/Regional guidelines. To co-ordinate with plant team i.e. QA, QC, Production department for availability of technical & legal documents in the given time-line. Review of documents received from plant team and co-ordinate with respective departments in case of any discrepancies. Review of dossiers prepared by team-mates. To ensure that the registration samples be available as per pre-defined time-frame. Submission of response to Queries / Deficiencies raised by Customers / Regulatory Authorities within timeline. Artworks review & approval Co-ordination with Clients / Customers for the registration updates, plant approval process etc. To maintain & update the records for all submissions & regulatory related activities

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Regulatory Affairs Executive /Assistant Manager