Regulatory Affairs Assistant Manager

OLIC (Thailand) Limited (Ayutthaya)

Ayutthaya, Thailand

OLIC has cultivated successful relationships that last. The company is a trusted partner to over 30 multinational companies, including most of the Big Pharma organizations. The OLIC manufacturing facility complies with GMP requirements following the PIC/S guide to Good Manufacturing Practice for Medicinal Products. Products made by OLIC serve not only the markets in Thailand and Southeast Asia, but also Japan, Australia, the US and Europe.

Detail posisi

OLIC (Thailand) Limited is seeking a Regulatory Affairs Assistant Manager to support the preparation and submission of regulatory documents and ensure compliance with local regulations in the pharmaceutical and healthcare industry.

Kewajiban

Key Responsibilities:
• Assist in the preparation and submission of regulatory documents for product approvals, including registration, variations, and renewals.
• Maintain up-to-date knowledge of regulatory changes and guidelines, ensuring the organization’s practices comply with local regulations.
• Collaborate with cross-functional teams, including R&D, Quality Assurance, and Marketing, to support regulatory strategies and product development.
• Manage communication with regulatory authorities, addressing inquiries and providing necessary updates.
• Conduct regulatory assessments for new products and advise on compliance requirements.
• Prepare and deliver training on regulatory affairs to internal teams.

Kualifikasi

Qualifications:
• Bachelor's degree in Pharmacy.
• Regulatory Affairs knowledge and experience.
• Experience in the pharmaceutical or healthcare industry.
• Strong attention to detail and organizational skills.
• Ability to work effectively in a team.
• Good communication and interpersonal skills.