Regulatory Affairs Specialist

The Regulatory Affairs Specialist is responsible for ensuring that all ORO Socks and Stockings and OMG Cosmetics products comply with government regulations and internal quality standards. This role manages product registration, regulatory documentation, and communication with relevant government agencies such as the FDA, DTI, and other certifying bodies. The position ensures that product labeling, claims, and formulations meet the necessary legal and industry requirements.

Key Responsibilities:

• Prepare, compile, and submit product registration dossiers to regulatory authorities (e.g., FDA, DOH, DTI).

• Monitor and ensure compliance of all products with applicable local and international regulations, including labeling and packaging requirements.

• Maintain and update regulatory documentation, including Certificates of Product Notification, Safety Data Sheets (SDS), and Technical Data Sheets.

• Coordinate with internal teams (R&D, QA, Marketing) to ensure regulatory requirements are considered in product development and launch.

• Review marketing materials, labels, and advertisements to ensure claims are substantiated and compliant.

• Liaise with regulatory agencies and act as the company's representative for audits and inspections.

• Keep the organization updated on regulatory changes, trends, and emerging compliance risks.

• Support product recalls or withdrawals by preparing documentation and coordinating with relevant teams and authorities.

• Assist in renewing business permits, licenses, and product certifications.

• Train internal staff on regulatory policies and changes as needed.

Qualifications:

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field.

• At least 1–2 years of experience in regulatory affairs, preferably in cosmetics, personal care, pharmaceuticals, or FMCG.

• Knowledge of FDA regulations, ASEAN Cosmetic Directive, GMP, and product registration requirements.

• Familiarity with product formulation documentation, safety assessments, and labeling regulations.

• Strong organizational and documentation skills with high attention to detail.

• Good communication and interpersonal skills to effectively liaise with regulatory bodies and internal teams.

• Proficient in MS Office; experience in regulatory management systems is a plus.

• Willing to work in Balintawak, Quezon City, and can handle multiple regulatory projects simultaneously.

Job Types: Full-time, Permanent

Pay: Php18, Php20,000.00 per month

Application Question(s):

• How much is your expecting salary?

Education:

• Bachelor's (Preferred)

Work Location: In person