Senior Executive

Bhargava Phytolab

3 - 5 years

1 - 3 Lacs

bhiwadi delhi / ncr

Posted:12 hours ago| Platform:

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Skills Required

drug regulatory affairs regulatory affairs usfda ctd api documentation investigator brochure actd hic guidelines

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

Preparation of CTD/ACTD & Country specific Dossiers
Handling queries obtained from different regulatory agencies and customers across the world.
Compilation, preparation and review of Technical Package of APIs.
Compliance to audits of regulatory bodies especially USFDA and EU.
Generation of documents from, Production, QC and QA of newly developed products
Responsible for record keeping and to ensure correctness of records pertaining to department. • Knowledge of ICH Guidelines to prepare documents accordingly
Lead, coordinate, write, critically review and provide strategic input on regulatory filing documents (e.g., eCTD Module 2 summaries, integrated summary documents, Investigators Brochure, clinical study reports)

Preferred candidate profile

Apply best practices for effective communication and problem-solving and demonstrate a professional manner.

The candidate must be a self-starter and demonstrate commitment to the task in a highly competitive growing sales environment.

Ability to use MS Office Package.

Fast learner with Strong, Confident communication & listening skills.

Innovation, making things happen per requirement.

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