Regulatory Manager

Job Title: Regulatory Manager

Department: Regulatory

Work Set Up: Onsite

Reports To: CSO

JOB SUMMARY

The Regulatory Manager is responsible for leading and managing the regulatory affairs function across both cosmetics and food product portfolios at Dermorepubliq Corporation and its corporate ecosystem. This role ensures that all products—from skincare formulations to nutraceutical beverages—meet the applicable requirements of the Philippine FDA (Food and Drug Administration), the ASEAN Cosmetic Directive, and other relevant local and international regulatory frameworks. The Regulatory Manager oversees product registration, license maintenance, pre- and post-market compliance, and coordinates with R&D, Quality Assurance, and Marketing to embed regulatory considerations throughout the product lifecycle.

KEY RESPONSIBILITIES

Product Registration & Licensing

• Manage end-to-end product registration and notification processes with the Philippine FDA for both cosmetics (Cosmetic Product Notification/CPN) and food supplements/processed food products (License to Operate, Certificate of Product Registration/CPR).
• Maintain and renew all product licenses, CPNs, CPRs, and company permits in a timely manner, ensuring zero lapse in registration validity.
• Prepare, review, and submit complete and accurate regulatory dossiers including product formulations, safety data, labeling artwork, and supporting technical documents.

Regulatory Compliance & Surveillance

• Monitor and interpret current and emerging regulatory requirements from the Philippine FDA, ASEAN Cosmetic Drive, and other relevant bodies applicable to cosmetics and food products.
• Conduct periodic internal compliance audits on product labels, marketing claims, advertising materials, and promotional content to ensure alignment with FDA regulations and applicable guidelines.
• Manage post-market regulatory activities including adverse event reporting, product recall coordination, and response to FDA queries or inspection findings.

Cross-Functional Collaboration & Advisory

• Provide regulatory guidance and clearance to R&D, Marketing, QA, and Supply Chain teams during new product development, reformulation, packaging changes, and ingredient sourcing decisions.
• Review and approve all product labels, package inserts, and advertising materials for regulatory compliance prior to print, publication, or distribution.
• Liaise directly with Philippine FDA officers, industry associations, and legal counsel on regulatory queries, applications, and compliance matters.

Team Leadership & Process Development

• Lead, coach, and develop the Regulatory Affairs team (including Regulatory Associates handling cosmetics and/or food portfolios), setting clear workplans and ensuring timely delivery of regulatory submissions.
• Establish and maintain a regulatory tracker, dossier management system, and standard operating procedures (SOPs) for all registration, renewal, and compliance workflows.

QUALIFICATION AND REQUIREMENTS

EDUCATION

• Bachelor’s degree in Pharmacy, Chemistry, Food Technology, Chemical Engineering, Biology, or a related life science field.
• A Master’s degree or postgraduate diploma in Regulatory Affairs is an advantage.
• Registered Pharmacist (RPh) or Registered Chemist (RCh) licensure is preferred.

EXPERIENCE

• Minimum of 5 years of experience in regulatory affairs within the pharmaceutical, cosmetics, food & beverage, or consumer health industry, with at least 2 years in a managerial or supervisory capacity. Demonstrated experience handling Philippine FDA registrations across both cosmetic and food/food supplement product categories is strongly preferred.

SKILLS

Technical Skills

• In-depth knowledge of Philippine FDA regulatory requirements for cosmetics (RA 9711, AO 2014-0030), food products and food supplements (RA 10611, RA 8976), and relevant ASEAN Cosmetic Directive provisions.
• Proficiency in preparing and managing regulatory dossiers, product registration submissions, and labeling compliance reviews; familiarity with FDA e-Portal/e-services and ASEAN CSMS.

Soft Skills

• Strong leadership and people management skills; ability to motivate and develop a regulatory team while managing multiple deadlines across two product categories.
• Excellent analytical, written communication, and stakeholder management skills; confident in interfacing with regulatory authorities, cross-functional teams, and external partners.

GROWTH AND DEVELOPMENT OPPORTUNITIES

• The Regulatory Manager role offers advancement toward a Director of Regulatory Affairs or Chief Compliance Officer position. The incumbent will have opportunities to lead industry working groups, represent the company at FDA public consultations and industry forums, access professional development training in ASEAN regulatory harmonization, and expand expertise into international markets (e.g., HALAL certification, EU Cosmetics Regulation, US FDA).

WORK ENVIRONMENT

• Primarily office-based in Antipolo City. Occasional travel to Philippine FDA offices, manufacturing partners, contract manufacturing organizations (CMOs), and industry events is expected.
• The role requires meticulous attention to regulatory deadlines; the incumbent must be prepared to manage time-sensitive FDA queries and submissions, which may occasionally require work outside standard hours.

EQUAL OPPORTUNITY STATEMENT

• Dermorepubliq is an equal opportunity employer and is committed to fostering a diverse and inclusive work environment