Regulatory Affairs Specialist — Growth & Flexible Career

PT Anugerah Pharmindo Lestari; Parañaque; Presencial; PHP 600.000 - 1.000.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Total Rewards program

Inclusive environment

Growth opportunities

Descripción de la vacante

Zuellig Pharma is a regional leader delivering healthcare solutions across Asia. We are seeking a Regulatory Affairs professional to liaise with regulatory authorities (FDA, DOH, DDB, PDEA, BAI) and coordinate licenses and permits for ZPC sites.

The role involves ensuring FDA Licenses to Operate and to Handle Dangerous Drugs are current, managing product registrations, and supporting regulatory strategy to accelerate time-to-market while maintaining compliance across markets.

Formación

• BS Pharmacy graduate with valid Pharmacist license.
• 1–2 years of Regulatory Affairs experience preferred.

Responsabilidades

• Represent company with Regulatory Health Authorities (FDA, DOH, DDB, PDEA, BAI, etc.)
• Coordinates with ZPC site Pharmacists on Licenses & Permits
• Ensures all ZPC Sites have updated FDA License to Operate and License to Handle Dangerous Drugs
• Identifies products for reporting and uploading in EDPMS
• Validates data uploaded in EDPMS
• Prepares and submits initial, renewal, notification and variation applications for LTO/LTH/PDEA
• Coordinates, monitors and updates validity and completeness of Client licenses (LTO, LTH, product licenses)
• Reviews and approves NPIS and MDRF to update Product Maintenance validity
• Reviews and approves LTO requests in the system
• Executes regulatory actions to support business needs
• Ensures adherence to current and new regulations
• Cascade regulations from governing bodies
• Keeps databases and reports updated and on time
• Provides regulatory strategy and intelligence to ensure speed to market
• Creates SOPs and processing updates for regulatory functions
• Represents the company with trade associations and advocates the company acts for

Conocimientos

Pharmacy degree

Licensed Pharmacist

Regulatory affairs

Educación

BS Pharmacy

Descripción del empleo

Zuellig Pharma is a regional leader delivering healthcare solutions across Asia. We are seeking a Regulatory Affairs professional to liaise with regulatory authorities (FDA, DOH, DDB, PDEA, BAI) and coordinate licenses and permits for ZPC sites.

The role involves ensuring FDA Licenses to Operate and to Handle Dangerous Drugs are current, managing product registrations, and supporting regulatory strategy to accelerate time-to-market while maintaining compliance across markets.