Regulatory Affairs - Philippines

• 30+ days ago

Genedrift

Role overview

Qualifications

Pharmacist
Experience in Drugs
Experience of 2-3 years
Language: English

Responsibilities

Ensuring necessary compliance with FDA, local laws/authorities
Evaluating dossiers for submissions, submission of dossiers both offline/online, and following up for updates
Responding to necessary queries, and meeting staff at FDA for resolution of queries
Represent clients for all matters relating to registrations and audits

Key facts

Remote from: Philippines
Full time
Mid-level (2-5 years)
Regulatory Affairs Manager
English

Hard skills

Other skills

Communication
Customer Service

About the company

Genedrift

Clinical Research (CRO)
Startup
11–50

Genedrift has been a trusted Regulatory and Pharmacovigilance provider across the entire business value chain. Whether pre or post market approved product safety, complaints management, medical inquiry support and post market surveillance through submission. Your organization's business requirements are unique and we excel at developing customized solutions leveraging our experience and team to automate and streamline business processes, aligning to our clients strategic objectives and providing a business solution that seamlessly integrates as a part of your organization, leading to customer satisfaction.

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Job description

This is a remote position.

Description
Ensuring necessary compliance with FDA, local laws/authorities
Evaluating dossiers for submissions, submission of dossiers both offline/online, and following up for updates.
Responding to necessary queries, and meeting staff at FDA for resolution of queries.
Represent clients for all matters relating to registrations and audits and Communicate with customers within Philippines for resolving queries / FDA issues.
Ensure the upkeep and safe custody of all original documents and records
Stay updated and continuously update internal documentation with reference to the guidelines of FDA
Travel to Bank for payments of FDA applications and update internal systems with all progress/updates.

Preferred Qualification
Pharmacist Experience in Drugs
Experience of 2-3 years

Language
English

An opportunity to Work from Home

Industry
Regulatory and Management Consulting

Employment Type
Full-time