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Jodas Expoim

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3.5

based on 225 Reviews

3 Jodas Expoim Jobs

Executive/Sr.Executive/Assistant Manager

Jodas Expoim

3.5

based on 225 Reviews

4-8 years

Hyderabad / Secunderabad

1 vacancy

Executive/Sr.Executive/Assistant Manager

Jodas Expoim

posted 6d ago

Job Role Insights

Fixed timing

Key skills for the job

Pharmacy Excel Operations Analytical Chemistry Basic Formulation Development

+ 4 more

Job Description

Experience: 4 8 years (preferably with sufficient hands on experience in Europe/ROW Regulatory Affairs).

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 the dossier 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-management skills. 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).

Employment Type: Full Time, Permanent

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What people at Jodas Expoim are saying

3.3

Rating based on 13 Assistant Manager reviews

Anonymous · Research & Development in Hyderabad / Secunderabad

Likes

They will give package hike in the join but not giving the increments is 1% to 5% my best suggestion is don't tempting for package definitely u will regret for joining in this organisation

Dislikes

1. Zero work life balance you should work for daily Genral shift to B Shift 2. We don't need to use our knowledge and skills hear if you use you will be here unparliamentary language from ur head 3. Worst Corporate HR department they hide many things before joining 4. Worst food if you eat regular definitely u will get healthy pro..Read More