Senior Executive

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.