Regulatory Affair in Microgen Hygiene Private Limited

Job Posted on Mar 6, 2018

Recruiter Type:Company
Company Name:Microgen Hygiene Private Limited
Address:313 Midas sahar plaza complex, andhri kurla road, andheri east
andheri kurla road,JB nagar
Mumbai, Maharashtra 400059
Contact Person:Recruitment Manager
Required in:Formulation Unit
Job Department(s):Regulatory Affairs
Job Title:Regulatory Affair
Job Details:• Compiling Dossiers as per specific country requirements
o Compiling ACTD/CTD Dossiers.
o Responding to queries.
o Internal Audits of Loan License Units.
o Departmental Budgeting
o Training
• Conduct and document regulatory activities in accordance with requirements and guidelines applicable international requirements and guidelines, and company procedures.
Assemble and prepare data packages for prescription medicine dossiers in current format for submission as per countries.
• Identifying Contract Manufacturing Organizations for the purpose of manufacturing our products.
Formulation in preparing the Pharmaceutical Development Reports for their clients, Master Formula Records, Stability Data Compilations.
Perform maintain
• Review/approval and change implementation of product labeling/artwork, formulations etc. based on global regulatory requirement and company policy. Maintain/update label folder with up-to-date and superseded labels. Maintain all product files (dossiers, correspondences from authorities and manufacturers).
Review and analyze Product Registration Dossiers for formulation products to ensure consistency, integrity and accuracy based on project specific regulatory guidelines.
Prepared and submitted CTD and ACTD dossier
Handling all the queries put forth by the Ministry of Health.
Well versed with ICH and CTD guidelines.
• Experience in compilation, review and submission of CTD dossiers to foreign drug agencies in ROW markets as well as general laisoning with the local FDA.
Regulatory Exposure:Required
Last Date:31/03/2018
Additional Details:Qualification: Graduate in Pharmacy/Science (preferably Microbiology) or MBA

Experience: At least 4+ years of experience as Regional Head, preferably in disinfectant industry/Hospital supply with an exposure 2 Full state.
Note:Please send your resume to above email address to apply for this job.

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