Key Qualifications

• Must be a Licensed Pharmacist.
• With at least 1–2 years of relevant experience in Regulatory Affairs.
• Experience in FDA processing and/or government bidding is required.
• Knowledgeable in regulatory compliance and documentation.
• Familiar with preparation and submission of regulatory requirements and permits.
• Proficient in Microsoft Office applications and documentation management.
• Detail-oriented with strong organizational and communication skills.
• Able to work under pressure and meet deadlines with minimal supervision.

Job Responsibilities

• Prepare, review, and submit regulatory documents to the FDA and other government agencies.
• Monitor product registrations, renewals, licenses, and compliance requirements.
• Ensure company compliance with applicable pharmaceutical and regulatory standards.
• Coordinate with internal departments regarding regulatory concerns and documentation.
• Handle government bidding requirements and related documentation
• Maintain accurate records of permits, licenses, and regulatory submissions.
• Monitor updates on FDA regulations and ensure timely implementation.
• Perform other related duties that may be assigned from time to time.