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

• Type of Job

  Full Time

• Work Location Type

  Work from Office