Senior Executive

2 weeks ago

Bhiwadi Delhi NCR, India Bhargava Phytolab Full time ₹ 15,00,000 - ₹ 25,00,000 per year

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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