Jubilant Generics Hiring For Regulatory Affairs Department
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| Jubilant Generics Hiring For Regulatory Affairs Department |
Jubilant Generics Job Vacancy Details
POSITION: MANAGER-REGULATORY AFFAIRS
Education Qualification (Highest): Master degree in Pharmacy
Desired Certifications: PGDRA
Experience Range: 8 – 12 years
No. of years post Highest Qualification : 10 years
Desirable experience : Minimum 5 years with knowledge of Dosage Regulatory Affairs is preferred
JOB DESCRIPTION:
PURPOSE OF THE JOB:
Job Context:
Drug Dossier Authoring, Reviewing & Submission drug product application, Management of Product life cycle management (LCM) activities, Assessment of changesfor US/ROW market to secure successful product approvals & LCM.
Challenges:
Thorough knowledge of CMC requirements, labelling requirements, regulatory impact of post approval changes and regulatory life cycle management.
KEY ACCOUNTABILITIES:
Accountabilities Scope of work
US/ROW
Drug Dossier Authoring, Reviewing & Submission drug product dossier application (US/Latam/ME/GCC/CIS)
Product life cycle management (LCM) activities
Assessment ofpost approval changes eCTD publishing
Thorough knowledge of CMC and Module 1 requirements
Authoring and review & submission of new dossier application and variations for US/ Latam/ ME/ GCC/ CIS markets
Authoring/review of Module 1 along with quality modules
Assessments of post approval changes, life-cycle maintenance and ensure timely post approval regulatory activities
To ensure timely submission of regulatory queries for timely approval of dossiers
Coordinate with cross-functional teams for desired regulatory data and accordingly plan & complete regulatory filing activities
Review and finalization of artwork/ label
Regulatory Intelligence and develops up-to-date knowledge with regard to technical guidelines and regulatory requirements, as well as technical trends
eCTD publishing
Interface with R&D and other business functions on a regular basis to ensure project-specific regulatory strategy is met as agreed in timely manner
Co-ordination with API vendors to resolve technical quires w.r.t. regulatory requirements
Co-ordinate with CMOs for site transfer projects and to provide resolution/way forward to CMO wrt regulatory requirements/ guidelines.
To review technical documents like process validation, AMV, Stability and composition etc. received from Site QA or R&D/ ADL against DMF/ Dossier requirements
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