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 Company Name: Amico Formulations LLP.



Post Name: Executive Regulatory Affairs 



Qualification: M.Pharm / B.Pharm



Experienced: 3 to 4 years



Job Description:  Hiring For Executive RegulatoryAffairs (RA) in Amico Formulations LLP



Important Details :



Location: Vadodara



Salary: ₹ 3,50,000 - ₹  4,25,000 P.A.



Contact: Raj Kamal- 7004994214



Interested Candidates can send resume at amicollphr@gmail.com



Selection Process: The selection will be on the basis of Interview.



Key Competencies required:


Job Description:


Experienced in Handling regulatory affairs for ROW market mainly African 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 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.



Thanks


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