Regulatory Affairs Specialist / Regulatory Affairs Analyst

Support regulatory approvals and ongoing compliance for the organization’s products, services, or operations. Interpret applicable requirements, prepare regulatory submissions, and coordinate with internal teams and authorities to maintain licenses, registrations, and authorizations.

Key responsibilities include:

• Monitoring regulatory requirements and assessing their impact on products and operations.
• Preparing and coordinating submissions, registrations, license applications, and renewals.
• Reviewing supporting documentation for accuracy, completeness, and consistency.
• Tracking submission progress, approval conditions, and regulatory deadlines.
• Coordinating responses to questions and requests from regulatory authorities.
• Assessing changes to products, processes, or labeling for regulatory implications.
• Maintaining regulatory records and supporting inspections and audits.
• Providing guidance to internal teams on approval requirements and compliance obligations.

Qualifications

• Degree in a field relevant to the industry, such as science, engineering, pharmacy, law, or business.
• Relevant experience in regulatory affairs, submissions, compliance, or quality assurance.
• Understanding of applicable regulatory frameworks and approval processes.
• Strong research, analytical, documentation, and problem-solving skills.
• Ability to interpret technical information and regulatory requirements.
• Excellent written communication and stakeholder coordination skills.
• Attention to detail, professional integrity, and the ability to manage competing deadlines.
• Familiarity with regulatory information management systems and relevant industry certifications is an advantage.