Regulatory Manager in Microgen Hygiene Pvt Ltd

Job Posted on Feb 23, 2018

Recruiter Type:Company
Company Name:Microgen Hygiene Pvt Ltd
Address:Microgen Hygiene Pvt. Ltd. Add: 313 Midas, Sahar Plaza, Andheri (E), MUMBAI, MAHARASHTRA 400059
Contact Person:Sushma Kumari
Required in:Formulation Unit
Job Department(s):Regulatory Affairs
Job Title:Regulatory Manager
Qualification:Any Graduate
Job Details:Job Description

• 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 Maintain/update label folder with up-to-date and superseded labels.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
Audit Experience:USFDA, WHO
Experience:4-10 years
Salary Per Annum:as per company norms
Last Date:15/03/2018
Additional Details:Company:- Microgen Hygiene Pvt. Ltd

Microgen Hygiene Pvt. Ltd- is the 2nd largest ISO Certified manufacturing and marketing company of Disinfectant & Antiseptics in India with International presence across the globe like Sri Lanka, Malaysia, Vietnam, South Africa, Zimbabwe, Zambia, Kenya, Uganda, Tanzania & Gulf Corporation Council Countries. With our world class technology that meets the most stringent International Manufacturing Standards, with an annual output of more than 12 thousand metric tonnes. Our manufacturing scales are accredited with WHO, GMP and ISO certifications.
Microgen Corporate Office is situated in the Western Suburbs of Mumbai. We have state-of-the-art world class manufacturing facility in the Himachal Pradesh, India. We are amongst the fastest growing organization in the disinfectant industry globally. All our products are manufactured as per the International set standards like CE marking; ISO and we have antimicrobial efficacy reports for our products. The disinfectant & antiseptic manufactured by us are marketed across the India & Globe by highly experienced personnel. Microgen offers comprehensive solution for Infection Control and hygiene and is set to conquer the whole world.

Our customer base is consists of Private, Corporate & Government Hospitals. More than 12000 Hospitals are being catered to spread awareness about hospital acquired infections around the country.

Our Product Range includes:-
1.Surface Disinfection
2.Instrument Cleaning & Maintenance
3.Hand Hygiene
4.Hemodialysis Disinfection
5.Instrument Cleaning & Instrument Sterilization
6.Skin Antiseptics
Note:Please send your resume to above email address to apply for this job.

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