FDA Regulatory

1 day ago

Manila, National Capital Region, Philippines De Castro Consulting Full time ₱800,000 - ₱1,200,000 per year
Job Summary

We are seeking a highly skilled and detail-oriented FDA Regulatory & CPR Processing Specialist who will lead the effort to obtain, maintain, and manage FDA Certificates of Product Registration (CPR) for our product portfolio. Possession of CPR processing expertise is non-negotiable — this role requires proven experience in registering health / regulated products with the FDA and handling all regulatory activities from submission to renewal, amendment, and audit.

Key Responsibilities

  • Manage the full life cycle of Certificate of Product Registration (CPR) applications: initial registration, renewals, amendments, cancellations, and revalidations.
  • Ensure compliance with FDA regulations, guidelines, and relevant laws for regulated products (food, drugs, cosmetics, medical devices, etc.).
  • Gather required technical, scientific, and regulatory documentation (e.g. test reports, safety data, labeling, certificates of analysis) and ensure completeness before submission.
  • Interface with internal teams (R&D, Quality, Manufacturing, Labeling, Legal) to collect inputs and ensure alignment with regulatory requirements.
  • Prepare and submit regulatory dossiers to the FDA's electronic or paper submission systems, monitor status, respond to observations or queries, and follow up to timely resolution.
  • Maintain regulatory tracking systems, master filing systems, logs (e.g. CPR status, expiration dates, amendment requests), and ensure audit readiness.
  • Monitor changes in regulatory frameworks, FDA updates, and guide product registration strategy accordingly.
  • Support regulatory inspections / audits, prepare responses to audit findings involving CPR issues, and coordinate corrective actions.
  • Provide guidance and training on CPR requirements to internal teams and stakeholders.
  • (Optional) Support health & safety or compliance teams for any regulatory / product safety interface.

Qualifications & Requirements

Mandatory / Non-Negotiable Requirements

  • Demonstrated, hands-on experience in obtaining and managing Certificate(s) of Product Registration (CPR) for regulated products (e.g. food, cosmetics, drugs, medical devices).
  • In-depth knowledge of local FDA / regulatory requirements, guidelines, and processes for product registration.
  • Experience in preparing dossiers, responding to regulatory queries, and handling registration renewals/amendments.

Education & Experience

  • Bachelor's degree (or higher) in Pharmacy, Chemistry, Biology, Regulatory Affairs, Life Sciences, or related field.
  • Minimum 2 years of regulatory affairs / product registration experience.
  • Prior experience interacting with regulatory authorities, preparing submissions, and undergoing regulatory audits.

Skills & Competencies

  • Excellent written and verbal communication skills, especially in regulatory language and scientific contexts.
  • Strong organizational, project management, and prioritization abilities.
  • Meticulous attention to detail, analytical mindset, and problem-solving skills.
  • Ability to work cross-functionally and coordinate with multiple internal stakeholders.
  • High integrity, confidentiality, and commitment to quality.

Other Requirements

  • Must keep abreast of regulatory changes, updates, and trends that affect product registration.
  • Willingness to undergo training, regulatory workshops, and certifications as needed.
  • Ability to travel or liaise with external regulatory bodies if required.

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