Regulatory Affairs Manager

1 week ago

Taguig, Philippines Viventis Search Asia Full time
Overview

Our client, a startup multinational company with offices in BGC, Taguig, is looking for a Regulatory Affairs Manager for their Infant Formula Group. The role will report to the Regional Marketing Director and is an individual contributor.

Job Summary

The Regulatory Affairs Manager ensures that all nutritional products, marketing materials, and business practices comply with local regulatory requirements (FDA, DOH, EO 51) and self-regulatory bodies (ASC). This role supports product registration, claims substantiation, label compliance, and advertising approvals, acting as a gatekeeper between the company and government agencies.

Duties & Responsibilities
  • Secure product registration, CPR (Certificate of Product Registration), and updates with FDA Philippines .
  • Ensure compliance with EO 51 , R.A. 9711 , R.A. 10611 , and other applicable laws.
  • Serve as the primary contact for FDA, DOH, DTI , and other government agencies.
  • Coordinate submission of dossiers, samples, and fees for new and reformulated products.

Labeling & Claims Review

  • Review and approve all product labels , nutrition facts , health and nutrient claims to ensure alignment with FDA guidelines.
  • Verify that all information complies with the Milk Code , especially for infant and follow-on formulas.

Advertising & Promotional Materials

  • Ensure all HCP-facing , consumer , and digital promotional materials are reviewed and pre-cleared by the Ad Standards Council (ASC) .
  • Serve as the compliance gatekeeper in medical detailing aids , RTD presentations , brochures , giveaways , etc.

Product Lifecycle & Scientific Support

  • Provide regulatory input during new product development , formulation changes , and importation planning.
  • Coordinate with R&D, Marketing, Sales, and Supply Chain to ensure regulatory alignment.
  • Stay updated on global regulations relevant to milk formulas (e.g., Codex, ASEAN Harmonization).

Documentation & Internal Training

  • Maintain regulatory files, certificates, audit trails, and correspondence.
  • Train internal teams (especially Medical and Marketing) on compliance with EO 51 and other local regulations.
Qualifications
  • Bachelor's degree in Pharmacy, Nutrition, Food Science, Chemistry , or related discipline.
  • At least 5 years' experience in regulatory affairs, preferably in infant nutrition .
  • Strong working knowledge of FDA Philippines processes , EO 51 , and ASC pre-clearance system.
  • Familiarity with product registration , labeling laws , and advertising standards in the Philippines.
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