Actide International
Location
Vadodara | India
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.
Regulatary Affairs,dossiers,regulatory documents
Designation: Assistant Manager/Sr..Regulatory Affairs Officer-Pharma
Vacancies: 1
Experience: 6.0 Year(s) - 7.0 Year(s)
Job tags
Salary
Rs 6 - 7 lakhs p.a.
