Regulatory Pharmacist Associate

Asia Cosmos Cosmetics Manufacturing; Quezon City; In loco; PHP 279.000 - 446.400; Tempo pieno

Vantaggi offerti da questo lavoro

13th Month Pay

Pag-Ibig Fund

Philhealth

SSS/GSIS

Descrizione del lavoro

A leading cosmetics manufacturer in Quezon City is seeking a Regulatory Affairs Associate who is a licensed pharmacist. This role involves managing product registrations, ensuring compliance with FDA and DOH guidelines, and collaborating with various teams. Ideal candidates should have at least one year of experience in regulatory affairs and strong analytical skills. The position offers benefits including mandated government perks and a supportive work environment.

Competenze

• At least 1 year of experience in regulatory affairs.
• Knowledge of FDA, DOH guidelines.
• Familiarity with GMP, GDP processes.

Mansioni

• Prepare and submit regulatory documents for product registration.
• Ensure timely renewal of Licenses to Operate.
• Coordinate with teams for regulatory compliance.
• Support audits and ensure accurate regulatory files.

Conoscenze

Regulatory processes understanding

Analytical skills

Organizational skills

Documentation skills

Microsoft Office proficiency

Communication skills

Formazione

Licensed Pharmacist or Nurse

Descrizione del lavoro

Job Description

Benefits

Government Mandated Benefits

• 13th Month Pay, Pag-Ibig Fund, Philhealth, SSS/GSIS

Description

About the Role:

• Asia Cosmos Cosmetics Manufacturing is currently looking for a Regulatory Affairs Associate who is a licensed pharmacist with relevant experience in the pharmaceutical industry.
• This position is ideal for individuals who have a solid understanding of regulatory processes and are capable of handling product registration, compliance, and documentation responsibilities with minimal supervision.

Qualifications:

• Licensed Pharmacist OR Licensed Nurse (PRC Registered)
• At least 1 year of experience in regulatory affairs within the pharmaceutical industry (but fresh graduates with excellent credentials are welcome to apply)
• Knowledgeable in FDA, DOH, and other applicable regulatory agency guidelines
• Experience in product registration, LTO renewals, and labeling compliance
• Familiar with GMP, GDP, and pharmacovigilance processes
• Strong analytical, organizational, and documentation skills
• Proficient in Microsoft Office applications (Word, Excel, PowerPoint)
• Excellent communication skills and ability to coordinate across departments

Key Responsibilities:

• Prepare, compile, and submit regulatory documents for product registration, amendments, and renewals to FDA and other regulatory bodies
• Monitor and ensure timely renewal of Licenses to Operate (LTO), Certificates of Product Registration (CPR), and other required permits
• Ensure compliance of product labeling, packaging, and promotional materials with local regulatory standards
• Coordinate with Quality Assurance, Marketing, and Supply Chain teams for regulatory-related concernsMonitor updates and changes in regulatory requirements and implement necessary compliance adjustments
• Support audits and regulatory inspections by preparing and maintaining accurate regulatory files
• Handle import/export permit applications and product notification processes