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