Website Jodas Expoim ltd
Post Name: EU/ROW Market – JD (Parenteral Dosage Formulations)
Experience: 4 – 8 years (preferably with sufficient hands on experience in Europe/ROW Regulatory Affairs).
Education: M Pharm/B Pharm
Position: Executive/Sr.Executive/Assistant Manager
Number of openings: 05
Job Description:
This position is responsible for EU/ROW Parenteral dossier preparation and guide/assist in technical review and finalization of documents required for regulatory filing in EU/ROW.
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.
The position would be responsible for ensuring Regulatory Compliance by keeping thedossier up-to-date throughout the product life-cycle.
Key Accountabilities Process
Operational:
1 Competent with EU/ROW-filing requirements with respect to Modules 2 & 3 (Parenteral Dosage forms). Ability to independently and effectively review technical documents related to Quality Module.
2 Well versed with EU/ROW-Regulatory Guidance and Processes (i.e. Ability to understand and interpret technical expectations as per applicable ICH and EMEA guidelines)
3 Sound knowledge of basic aspects of a Parenteral Dosage Formulation (primarily pharmaceutical development along with general analytical aspects)
4 Should be aware of Post-approval variation requirements in EU/ROW 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.
Strategic:
1 Should have excellent work-management and time-managementskills. Should have flexibility to handle multiple tasks at a time and ability to plan and execute assignments in case of changing organizational priorities.
People Related:
1. Having positive attitude towards work as well as people.
2. Should be transparent in dealing with the team members and should be able to guide them to
bring the best out of them
3. Good interpersonal skills to deal with various cross-functional teams.
Basic Skills: Good written and verbal drafting and communication skills, Sound Computer knowledge of basic software’s (e.g. PDF, MS-office/Excel).
Location: Plot No S-1, Sy No: 1043 & 1048, 3rd Floor,
NSL Centrum, KPHB Phase 3, Kukatpally,
Hyderabad, Telangana 500072
