Jodas Expoim Hiring For Regulatory Affairs Department

Jodas Expoim Hiring For Regulatory Affairs Department 

Jodas Expoim Hiring For Regulatory Affairs Department 

Job Description Of Jodas Expoim 

Position: Regulatory Affairs - EU Market - Injectables for our Head Office.

Education : B. Pharmcy/M. Pharmacy

Experience : 4 - 8 Years

Location : KPHB Phase III, Hyderabad

Job Description :

1 This position is responsible for EU Parenteral dossier preparation and guide/assist in technical review and finalization of documents required for regulatory filing in EU.

2 The position should aim at ensuring accurate and high quality documentation on timely basis to meet organizational requirements and to ensure faster approval with minimal queries.

3 The position would be responsible for ensuring Regulatory Compliance by keeping the dossier up-to-date throughout the product life-cycle

4 Competent with EU-filing requirements with respect to Modules 2 & 3 (Parenteral Dosage forms).

5 Ability to independently and effectively review technical documents related to Quality Module.

6 Well versed with EU-Regulatory Guidance and Processes (i.e. Ability to understand and interpret technical expectations as per applicable ICH and EMEA guidelines)

7 Sound knowledge of basic aspects of a Parenteral Dosage Formulation (primarily pharmaceutical development along with general analytical aspects)

8 Should be aware of Post-approval variation requirements in EU and have ability to take decisions related to the variation categorization. Should have basic QA knowledge to enable correct review of related change controls and decide on any impact on regulatory front in terms of variation.

Interested candidates please share your profile to recruitment4@jodasexpoim.in