Regulatory Affairs Executive

Amico Formulations LLP

Regulatory Affairs Executive

Location: Vadodara, Gujarat

Must have Experience in Pharma Industry

Must have experience in handling regulatory affairs for ROW market mainly Central and Latin America and Africa for Pharma Formulations.

Preparation, Compilation & Review of Registration documents that include Administrative & Technical.

Reviewing the technical documents provided by QA, QC, Production. Providing them the report of shortcomings & ensures them to correct the documents.

Handling RFIs (Requested Further Informations) queries raised by Importer/ Agent/ Regulatory authorities during evaluation of technical data.

Coordinating concerned (QA, QC, Production, Packing & Purchase) departments in the process of sample preparation.

Coordinate & submission of CTD/ACTD/Country Specific Dossiers/DMF (OP) to regulatory agencies.

Coordinate & provide support to team for preparation and dispatch of regulatory documents & dossiers in agreed time-frames.

Responsible for planning, coordinating and managing day to day regulatory affairs activities in a timely manner.

Providing technical knowledge of the data used in CTD, ACTD & Dossiers to members of regulatory team.

Fill up customer questionnaires by collecting information from various concerned departments.

You should be good in man - management & co - ordination with all the departments Interact with various administrative, legal & factory departments to collect documents required for regulatory compilation on time.

Maintenance of the complete history of each drug product

Experience : 6 - 8 Years

No. of Openings : 1

Education : B.Pharma, M.Pharma

Role : Regulatory Affairs Executive

Industry Type : Pharma / BioTech / Clinical Research

Gender : [ Male / Female ]

Job Country : India