Senior Regulatory Officer

5 days ago

Quezon City, National Capital Region, Philippines Karl Group Holdings Corp. Full time ₱300,000 - ₱600,000 per year

Job Title: Senior Regulatory Officer

Location: Philippines

Industry: Food and Drug Administration (FDA) compliance, Regulatory Affairs

Job Summary:

The Regulatory Officer ensures that company products comply with the regulations and standards set by the Philippines Food and Drug Administration (FDA) and other relevant regulatory bodies. This role includes preparing, submitting, and maintaining product registrations and licenses for pharmaceuticals, cosmetics, medical devices, and other regulated products; monitoring regulatory changes; coordinating with FDA on inspections; and ensuring all compliance documentation is accurate and current.

Key Responsibilities:
  • Prepare and process registration dossiers for new products and renewals of Certificates of Product Registration (CPR) for drugs, cosmetics, and food products.
  • Prepare and coordinate submission of medical device applications including Certificate of Medical Device Notification (CMDN) and Certificate of Medical Device Registration (CMDR).
  • File applications with the FDA and track approval statuses, ensuring timely updates of licenses to operate (LTO) for all business units.
  • Manage and maintain regulatory compliance documentation including product labels, government licenses, and FDA compliance reports.
  • Act as the primary liaison during FDA inspection visits; prepare necessary documents and support workplace compliance.
  • Monitor, interpret, and communicate new FDA guidelines, rulings, and regulatory changes impacting product registration and operations.
  • Represent the company in FDA forums, seminars, and workshops.
  • Establish and maintain systems to track and monitor licenses and registrations for all product categories.
  • Support product development and marketing teams by reviewing product labels, claims, and technical documentation in compliance with FDA regulations.
  • Coordinate product testing and submission of samples to accredited agencies as required.
  • Assist in compliance and regulatory filings for both local and international markets as applicable.
Qualifications:
  • Licensed Pharmacist, Medical Technologist, or graduate in Pharmacy, Medical Technology, Biochemistry, or related life sciences field.
  • Experience (typically 2-5 years) interfacing with the FDA or managing regulatory affairs, particularly in medical devices, pharmaceuticals, cosmetics, or food products.
  • Good planning, organizing, and communication skills (both oral and written).
  • Willingness to travel internationally for industry exhibits and conferences.

  • Detail-oriented, assertive, resourceful, and able to work independently or in teams.

  • Familiarity with technical documentation, filing systems, and SOP development in regulatory affairs.

  • Knowledge of FDA regulations and ASEAN harmonized technical requirements for medical devices is highly desirable.

Additional Skills:
  • Proficiency with regulatory compliance software/tools is a plus.
  • Ability to handle multiple product categories and business units efficiently.
  • Knowledge of international regulatory requirements for product registration is advantageous.

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