Regulatory Affairs Specialist

About the role

Johnson & Johnson is looking for a Regulatory Affairs Specialist based in Panama City. The specialist supports the development and execution of regulatory strategies so that products can be registered, approved, commercialized and managed through their lifecycle, while complying with local and international regulatory requirements and company standards.

Key responsibilities

• Implement regulatory strategies and give regulatory guidance for product development, manufacturing, registration, importation, commercialization and lifecycle management.
• Analyze regulatory requirements, scientific and product data to identify risks and opportunities, and recommend pathways to timely approvals.
• Plan, prepare, review and coordinate regulatory submissions for new and existing products, and respond to Health Authority questions and requests for information.
• Maintain regulatory approvals and registrations, monitoring renewals, variations, labeling updates and other obligations.
• Review product labeling, claims and promotional materials for regulatory alignment.
• Support interactions with Health Authorities, including documentation, scientific justifications and meeting materials.
• Take part in internal and external audits and inspections, and keep regulatory records, databases and trackers up to date.
• Share regulatory knowledge and guide junior colleagues.

Required profile

• Strong knowledge of regulatory requirements and product registration processes.
• Ability to interpret scientific, technical, clinical and regulatory information.
• Planning, organization and project management skills, with the ability to handle several regulatory activities at once.
• Effective written and verbal communication and collaboration in cross-functional, multicultural settings.
• Proactive risk identification and continuous improvement mindset.

Required skills

• Medicines and device development and regulation
• Regulatory affairs management and regulatory compliance
• Risk assessments and product licensing