Regulatory Affairs Pharmacist Based in Bangpoo

Are you highly responsible persons?
Are you at your very best when there’s problem to be solved?
Are you an extremely excitable person?

Mega Lifesciences is looking for a Regulatory Affairs Pharmacist to work closely with Regulatory Affairs Manager in a fast-paced environment that will offer ample opportunities to learn and expand your experience and expertise. 

Job Summary 

As a Regulatory Affairs Pharmacist,your key tasks are as below:

• Preparing CTD and ACTD Ddossiers for ROW markets
• Responsible for handling queries received from respective health authorities
• Preparing documents for filing relevant variations
• Coordinating with other departments and outsourced manufacturers for arranging documents related to product approvals.

Qualification & Experience 

Applications are invited from the potential talents who meet the following criteria:

• Bachelor’s Degree or Master’s Degree in Pharmacy
• Minimum 3 - 5 years of experience in pharmaceutical industry or in Drug Regulatory Affairs
• Experience in a global/matrix environment or cross-functional teams in the Pharmaceutical industry or in clinical research
• Fluency in English - written and verbal
• Self-motivated individual with organizational skill
• Creative, hardworking, and strong problem solving ability
• Ability to work under pressure and meet deadlines
• Open & Interested  to work in Bangpoo, Samutprakarn

Skill & Knowledge 

The ideal candidate will have good command of computer skills (MS-Office and Internet). In addition, the candidate must possess strong management, problem analysis skills along with interpersonal and communication skills. Knowledge in drug dossier regulations for ROW markets preferred.