• Supports regulatory department to ensure efficient and compliant business processes and environment. Ensure effective coordination and implementation of regulatory activities in support of new product approval/registration and maintenance.
• Determine and communicate submission and approval requirements.
• Participate in new product development teams to provide input and expertise on regulatory requirements, determination of global regulatory strategies, review and approval of documentation to support regulatory submissions worldwide.
• Assess the acceptability of documentation for submission filing to comply with regulatory requirements for clinical trials, marketing applications and corporate goals, to secure submission approval.
• Monitor and assess impact of changing regulations on submission strategies.
• Provides strategic direction and advice regarding regulatory pathways and timelines.
• Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
• Provide medical review and assure compliance of promotional materials in accordance with approved labelling,application regulations and industry standards
• Participate in post-market clinical studies (design, execution, review of data, writing publications).
• Participate in local industry/trade association meetings
• Performs additional duties as assigned.

Qualifications

• Min Degree in any science related field
• Minimum 5 years of experience in either domestic and regional regulatory affairs would have an advantage
• Min of 2-3 years experience as a RA Manager would be preferred
• Familiar with regulatory affairs such as ASEAN MDD, new registration and renewal of product registrations in medical device (manufacturer or distributor) would be at an advantage

Primary Location
Thailand-Bangkok-Bangkok-

Organization

Johnson & Johnson (Thailand) Ltd. (8585)

Job Function

Regulatory Affairs

Requisition ID