Opening for Regulatory Affairs (AGM) at
Unison Pharmaceuticals
Regulatory Affairs -Assistant General Manager
B.Sc. B.Pharm / M.Sc. / M.Pharm with 12 & above years of hands-on experience in Regulatory Affairs like Regulatory assessment at the time of New Product Development, Dossier Preparation, Dossier filling, Tender filing, Post submission to MOH (Ministry of Health), Post approval (Product Life Cycle Management and Variation filing (Notification / Minor / Major).
Regulatory Affairs -Assistant General Manager
B.Sc. B.Pharm / M.Sc. / M.Pharm with 12 & above years of hands-on experience in Regulatory Affairs like Regulatory assessment at the time of New Product Development, Dossier Preparation, Dossier filling, Tender filing, Post submission to MOH (Ministry of Health), Post approval (Product Life Cycle Management and Variation filing (Notification / Minor / Major).
Job Description
Regulatory assessment at the time of new
product development
·
Guideline evaluation specific to the region and sharing specific
requirements to F&D and ADL.
·
Support F&D team in reference product selection based on
market specific requirement. positions and analysis of the existing level of
competencies.
Dossier Preparation
·
Master dossier preparation
Common Technical Document (CTD)
1. Review of
modules 1 5 (Administrative, Quality Overall Summery (QOS), Quality Part (Body
of Data), Non Clinical and Clinical
2.
Arrangement of Drug Master File as per regulatory requirement
Asian Common Technical Document (ACTD)
Review of parts 1 4 (Administrative, Quality Part (Body of Data), Non Clinical and Clinical
Review of parts 1 4 (Administrative, Quality Part (Body of Data), Non Clinical and Clinical
Review of Country specific dossier prepared
RA team members
1. Table of
content finalization for country specific dossier
2. Finalization
of administrative part which includes; Artwork finalization, Certificate of
Pharmaceutical Products, Free sell certificate, Product permission, GMP
certificate, manufacturing license, Letter of access and GMP certificate from
API manufactures, Declaration letter for clinical and non-clinical
3. Finalization
of Periodic Safety Update Report (PSUR)
4. Arrangement
of risk management plan through third party
5. Arrangement
of registration samples / working standards / impurities and any other
requirements
Final review of dossier
Tender filing
·
Guideline evaluation specific to the region and sharing specific
requirements to BD team.
·
Compile and review tender application and submit to BD team in
coordination with R&D head.
Post
submission to MoH (Ministry of Health)
1. Query
response to ministry
2. Support to
Partner, Service Provider and MoH for fast approval
Post approval (Product Life Cycle Management)
1. Verification
of registration certificate
2. Verification
of export order
Variation filing (Notification / Minor /
Major)
1. Guideline
assessment for variation
2. Review of
variation application according to regulatory requirement
3. Filing of
application to partner / MoH
4. Verification
of approval inline with the application
5. Ensure
revision of all related documents at plant and F&D level
Contact Person: Manisha Rajput
Interested candidates may also email their resume to career@unisonpharmaceuticals.com
Interested candidates may also email their resume to career@unisonpharmaceuticals.com
Please share this information with your colleagues, professional friends and family, it might help someone build a career.
Join for Regular Job Updates in Telegram...
No comments:
Post a Comment