Regulatory Affairs Staff

Job description:

1. PURPOSE OF THE POSITION

The position focuses on regulatory documentation, application processing, compliance monitoring, and records management.

1. SCOPE OF RESPONSIBILITY

This position applies to the Regulatory Affairs Department of Drugmakers Laboratories Inc. and involves coordination with internal departments and external regulatory agencies to ensure timely product registration, licensing, and regulatory compliance.

1. QUALIFICATIONS

The Regulatory Affairs Staff must meet the following qualifications:

• Bachelor’s degree in Pharmacy, Chemistry, or Chemical Engineering
• Licensed Pharmacist is an advantage (for Pharmacy graduates)
• At least one (1) year of relevant experience in regulatory affairs or a related field is preferred; fresh graduates may be considered
• Knowledgeable in FDA rules, regulations, and regulatory procedures
• Familiar with business laws and applicable government regulations
• Proficient in computer applications, particularly MS Office
• Strong analytical, organizational, and documentation skills
• Detail-oriented with good problem-solving abilities
• Able to work independently and meet regulatory deadlines

1. DUTIES AND RESPONSIBILITIES

• Review regulatory documents, product samples, and payment requirements prior to submission to regulatory authorities.
• Prepare, process, and submit applications to designated government agencies in accordance with regulatory requirements.
• Coordinate with regulatory personnel to monitor the status of applications and follow up on the release of official documents such as CPRs, permits, and licenses.
• Prepare regulatory documentation and accomplishment or progress reports as required.
• Maintain accurate inventory of regulatory supplies, materials, and reference documents.
• Ensure that all regulatory records, files, and documents are properly maintained, updated, and systematically organized.
• Ensure compliance with document control and record-keeping standards.
• Perform other regulatory-related duties as may be assigned by the immediate superior from time to time.

1. WORKING CONDITIONS

• Office-based position within the Regulatory Affairs Department
• Requires coordination with government agencies and internal departments
• May involve participation in audits, inspections, or regulatory meetings

1. AUTHORITY AND ACCOUNTABILITY

• Accountable for the accuracy, completeness, and timeliness of regulatory submissions and documentation
• Required to observe confidentiality, integrity, and compliance with company policies and regulatory standards