Senior Regulatory Affairs Specialist

Job Description:

• The Senior Regulatory Affairs Specialist is responsible for maintaining all pharmaceutical product licenses in Thailand, Cambodia and Myanmar market. Ensure business continuity through the product registration, lifecycle management, regulatory compliance and vital documents management.
• Prepare, coordinate and submit regulatory applications, including registrations, variations, renewals and lifecycle maintenance activities.
• Ensuring that life-cycle management activities of pharmaceutical products are carried out in compliance with Johnson & Johnson standards.
• Monitor regulatory changes and assess potential business impact to ensure compliance as per local market regulations or requirements, as well as internal standard procedures.
• Managing all changes and quality issues related to regulatory activities according to internal procedures.
• Coordinate communications with the Thai FDA and relevant stakeholders.
• Coordinating with cross functional team to ensure that new products and/or approved variations are implemented on time for uninterrupted supply chain including launch readiness.
• Ensuring timely implementation of package inserts and packaging components.
• Ensuring that product package inserts are not deviated from the international package inserts or otherwise follow management of local labeling deviation.
• Assessing and communicating any new local regulations that impact the business to all relevant stakeholders.
• Establishing and maintaining strong relationships with internal stakeholders across local, regional, and global levels, as well as external stakeholders such as health authorities and third-party suppliers.
• Manage vital documents retention in RA storage room and keep the vital document list storage at outsource vendor e.g. Iron Mountain company up to date.
• Keep the registration licenses up to date throughout the lifecycle of products as required by local regulations and as data emerges, where applicable.
• Performing any additional duties assigned by your supervisor.

Minimum Qualification

• University degree in pharmacy, Pharmaceutical Sciences.
• Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers - proficiency in written and oral English is required.
• Excellent computer proficiency e.g. MS Office.
• Must be able to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude.
• Previous experience in preparing documents for health authority submissions is desirable.
• Ability to interpret complex issues and technologies and present them in simple terms.
• Demonstrated ability to handle multiple projects.
• Must be able to develop and maintain excellent working relationships.
• Good collaboration with and communication to all relevant stakeholders

Other requirements

• Pharmacist license