Johnson& Johnson (Thailand)

Consumer OTC RA Specialist

Overall purpose of job:

• Keep the registration licenses up to date throughout the lifecycle of all products and line extensions for

• (OTC & CHC) Products for Thai & LCM (Lao/Cambodia/Myanmar).

• Ensure high level compliance to all local regulations and requirements.
• Establish strong engagement with external stakeholder such as local health authorities and business partner.

Essential duties and responsibilities:

• Register all new products and line extensions for (OTC & CHC) Products for Thai & LCM

• (Lao/Cambodia/Myanmar) to get approval as planned to ensure the new product launch will be as scheduled.
• Keep the registration licenses up to date throughout the lifecycle of products as required by local regulations.
• Renew all products to be active as planed and ensure that the licenses are valid to ensure that supply can continue smoothly.
• Establish and maintain a good relationship with internal, e.g., inter- and intra-department at
• local/regional/global level, and external stakeholders, e.g., FDA, third party suppliers.
• Ensure all outgoing messages are in compliant with local regulations and company requirements.
• Comply with local regulations and requirements. Assess and communicate new local regulations impacting business to all relevant stakeholders.
• Ensure all changes and quality issues relevant to regulatory activities are well-managed in
• accordance with internal procedures.
• Review and ensure artwork compliance as required by local regulations.
• Other jobs as assigned by supervisor.

Qualifications

Job Requirements

Essential knowledge and skills:

• Minimum 1-2 years' experience in area of Regulatory Affairs responsible for pharmaceutical products and consumer products is an advantage.

• Bachelor's degree in Pharmaceutical Sciences with good communication in English.
• Computer literacy-skill to use business applications. Excellent skills in MS Office (Proficient in MS Excel) preferred.
• Ability to work on multiple tasks and under pressure.

Core competencies required for this role:

• Ability to effectively handle and manage all regulatory activities throughout lifecycle of Consumer

• (OTC & CHC) products and provide good support to other departments.
• Good interpersonal skills and good collaboration with and communication to all relevant stakeholders.

Primary Location
Thailand-Bangkok-Bangkok-

Organization

Johnson & Johnson (Thailand) Ltd. (8585)

Job Function

Regulatory Affairs

Requisition ID

2105935682W