Job vacancy Regulatory Affairs Manager

COMPANY OVERVIEW

Our client is an MNC that has been deeply engaged in the pharmaceutical market for 30 years. They have three major business segments: dermatology and medical aesthetics, ophthalmology, and consumer healthcare

JOB RESPONSIBILITIES

• Responsible for local regulatory submissions plan
• Contribute to development of regulatory strategies for new products and changes to existing products in line with business objectives
• Product submissions, registration and compliance to international regulatory standards by preparation and submission of technical dossiers (ICH) or technical files to regulatory authorities in the country
• Manage compilation and submission of responses to queries raised during the evaluation process of NDAs through coordination with relevant parties
• Manage compliance of product labels and liaise with supply chain for the implementation in commercial shipments in the country
• Life cycle management of existing product portfolio to ensure regulatory compliance and license renewals to support business needs
• Provision of regulatory advice to regulatory colleagues in the region and other colleagues in the organization
• Collation of information from the region for periodic safety updates reports
• Responsible for all regulatory operations that involve liaising work within the company functions such as Production, R&D and QA departments as well as external agencies such as health authorities in the country.
• Manage company regulatory affairs activities including reports, license transfers and renewals to ensure compliance with government requirements and company standards
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  JOB REQUIREMENTS

• Pharmacy, Science degree or equivalent
• 5-10 years relevant working experience in RA settings in the country, product registrations and life cycle management
• Pharma experience
• Medical device experience a plus
• Quality assurance experience a plus
• English business level speaking

JOB BENEFITS

• Salary from 46,000,000VND to 70,000,000VND (Negotiable)
• Premium Healthcare Package.
• Global working environment & Abroad Opportunities
• Training & Development Opportunities
• Others attractive benefits

Apply online or feel free to contact us directly for more information about this opportunity. Due to the high volume of applicants, we regret to inform that only shortlisted candidates will be notified. Thank you for your understanding.

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₫46,000,000 - ₫70,000,000 Monthly (VND)

27 Dec, 2024 (221 days left)