Job Description

Our client is one of the well-known pharmaceutical manufacturing companies in Thailand.

The company is looking for a suitable candidate for the position of Regulatory Affairs Manager to join their team.

Job Description:

• Overseeing the registration of new products in alignment with the launch plan to ensure the timely introduction of products to the market.
• Managing product license renewals, company licenses, GMP clearances, amendments, and annual reports to maintain regulatory compliance.
• Ensuring that all registration licenses remain up to date throughout the product lifecycle, adhering to local regulatory requirements.
• Effectively managing regulatory activities related to changes and quality issues to maintain compliance and ensure smooth operations.
• Providing strategic regulatory guidance to ensure alignment with all relevant regulations and standards.
• Building and maintaining strong professional relationships with local health authorities and regulatory agencies as required.
• Taking responsibility for routine regulatory tasks associated with the assigned product portfolio.
• Coordinating activities related to Bioavailability (BA) and Bioequivalence (BE) studies, clinical study centres, and regulatory authorities.
• Acting as the Pharmacovigilance coordinator to enhance public health and safety concerning the use of pharmaceutical products.

Qualifications:

• A bachelor’s degree in Pharmaceutical Sciences or a related field.
• 5–8 years of experience in Regulatory Affairs, specifically in pharmaceutical product manufacturing.
• Strong understanding of drug regulations, registration processes, and regulatory concepts and principles.
• Highly responsible, well-organized, and a team player with a positive attitude and open-minded approach.
• Exceptional communication, negotiation, interpersonal, problem-solving, and decision-making skills.
• Strong collaboration and communication capabilities with relevant stakeholders.
• A good command of English is a must.