Clinical Regulatory Officer

1 week ago

Ortigas Post Office P, Philippines iSWerk Full time

Be a part of our fast-growing team and unchain all the possibilities

What is your mission?

We are looking for a Clinical Regulatory Officer to ensure our quality management system runs efficiently and meets regulatory standards. You'll oversee supplier qualifications, CAPA tracking, audit readiness, training compliance, and document control. This role is perfect for someone who thrives on structure, precision, and continuous improvement in a regulated environment.

You will provide the best service to our partner brands by performing these tasks:

  • Quality System and Compliance
  • Coordinate and maintain quality system processes including supplier qualification, change control, CAPA, and deviation tracking

Training and Qualification Management

  • Administer and track employee training and qualification programs
  • Maintain accurate training records and coordinate updates with managers and HR
  • Ensure all certifications and required trainings are completed on time
  • Support qualification reviews and maintain updated resumes and job descriptions

Document Control and Records Management

  • Manage document control including issuing, revising, and retiring SOPs and quality records
  • Maintain complete, version-controlled, and audit-ready documentation
  • Prepare document packages for inspections and oversee record archiving
  • Support customer complaint handling and follow-up documentation
  • Prepare for internal, external, and regulatory audits by scheduling, organizing, and tracking findings
  • Compile and report quality metrics and KPIs to support continuous improvement
  • Ensure timely adherence to policies and standard operating procedures across departments

Who are we looking for?

  • Bachelor's degree preferred, or equivalent experience in quality or compliance roles
  • Strong background in quality management systems, regulatory compliance, or audit preparation
  • Hands-on experience in document control, deviation tracking, and CAPA management
  • Knowledge of FDA, ISO, or other regulatory audit processes
  • Experience with regulatory processes in clinical trial or life sciences environments
  • Proficiency with digital quality management systems such as Kivo or similar tools
  • Strong attention to detail and accuracy in documentation and reporting
  • Excellent English communication skills, both written and verbal
  • Ability to multitask, prioritize, and meet deadlines in a structured environment
  • Proactive, dependable, and collaborative team player

Company Perks:

  • Above-industry salary package and incentives
  • Comprehensive HMO benefits and life insurance from day 1
  • Free learning and development courses for your personal and career growth
  • Dynamic company events
  • Opportunities for promotion
  • Free meals and snacks

Job Types: Full-time, Permanent

Pay: Php30, Php35,000.00 per month

Benefits:

  • Company Christmas gift
  • Company events
  • Gym membership
  • Health insurance
  • Life insurance
  • Opportunities for promotion
  • Paid training
  • Pay raise
  • Promotion to permanent employee
  • Staff meals provided
  • Work from home

Experience:

  • Regulatory audit processes: 1 year (Required)
  • Quality Assurance: 1 year (Required)
  • HIPAA: 3 years (Required)

Work Location: In person

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