Regulatory Compliance Manager

1 day ago

Bacoor, Calabarzon, Philippines HRTX Full time ₱1,200,000 - ₱2,400,000 per year

Company Location: Molino, Bacoor Cavite

Work Setup: Full Onsite

Work Schedule: 8am to 5pm | Monday to Friday

The Compliance Manager is responsible for ensuring the company's full adherence to regulatory requirements, including FDA, ISO standards, and other relevant industry regulations. This role involves developing, implementing, and monitoring compliance policies, managing necessary documentation, and leading a team of specialists to mitigate compliance risks.

Qualifications:

  • Bachelor's degree in Regulatory Affairs, Quality Management, Business, or a related field; advanced certifications in compliance or quality management are a plus.
  • Minimum 5-7 years in regulatory compliance, quality assurance, or a similar field, with a focus on FDA and ISO compliance.
  • Expertise in FDA regulations, ISO standards, and compliance documentation management; proficiency in compliance software.
  • Detail-oriented, analytical, highly organized, with excellent communication skills and the ability to manage multiple projects.

Key Responsibilities:

  • Oversee company-wide compliance with FDA, ISO, and other relevant regulations, ensuring adherence across all departments.
  • Ensure products, labeling, and manufacturing processes meet FDA requirements; manage FDA submissions and communications.
  • Lead ISO certification processes and coordinate with teams to integrate ISO standards into operations.
  • Maintain and renew all necessary business permits, licenses, and certifications.
  • Conduct risk assessments, develop mitigation strategies, and provide compliance training.
  • Manage compliance documentation, ensuring secure storage, organization, and accessibility for audits.
  • Collaborate with R&D, manufacturing, and legal teams to align on compliance initiatives and communicate with regulatory agencies.
  • Monitor regulatory changes and propose improvements to compliance strategies, processes, and training.
  • Support career development for the team through seminars, trainings, and collaboration with HR.
  • Lead, manage, and provide guidance to a team of compliance specialists, ensuring efficient execution of compliance tasks and fostering a culture of continuous improvement.

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