Jubilant Generics Hiring For Regulatory Affairs Department 

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 Location: Greater Noida, Uttar Pradesh





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

Preparation & Submission
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

Coordination

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

How To Apply For Jubilant Generics Job 

Click Here For Apply