Regulatory Affairs Manager

Job Description:

• Responsible for Pharmaceutical product registration, renewal, post approval changes and advertising approval by Thai FDA in compliance with Thai FDA regulations.
• Prepare registration dossier according to FDA requirement and prepare the documents for post approval changes liaising with FDA requirements.
• Timely communicate internal teams about updates from Thai FDA on registration status and regulatory relevant activities.
• All required elements for product registration are scheduled correctly and in place to meet the target filing and registration dates.
• Submission of Pharmaceutical products for registration and follow up with FDA to obtain timely or earliest approvals.
• Able to manage in technical skills including regulatory and product quality perspectives.
• Coordinate with internal and global regulatory team to ensure that the registration dossier, packaging artworks meet the requirements of Thai FDA and properly manage and resolve the issues.
• Support and work closely with cross functional teams such as sales & marketing and quality team of relevant issues.
• Responsible for all activities of RA and relevant related RA activities.

Qualifications:

• Bachelor’s degree in Pharmaceutical Science
• Minimum 5 years working experience in regulatory affairs area (experience in pharmaceutical/biological product in an advantage)
• Have good experience in working with FDA in preparation of documents for the product registration until product marketing approval.
• Understanding of the rules and regulations for Pharmaceutical/Biological products.
• Good command in English (speaking, reading and writing)
• Good at computer skills (MS Office, MS Excel, Adobe etc.)
• Male or Female, aged between 30-40