Assistant Manager/tory Affairs Officer- Pharma

7 hours ago

Vadodara, Gujarat, India Actide International Full time ₹ 5,00,000 - ₹ 15,00,000 per year


Job Description:

Job Description:  Experience in handling regulatory affairs for ROW market mainly Central and Latin American, African & Asian countries 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 Information's) 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.

? 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.

? Prepare and compliance of Modules-I as per regulatory requirement.

Note: The candidate can work individually.


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