Specialist Regulatory Affairs

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

Job Description

Zuellig Pharma is a leading healthcare solutions company in Asia, and our purpose is to make healthcare more accessible to the communities we serve. We provide world-class distribution, digital, and commercial services to support the growing healthcare needs in this region.

The company was started a hundred years ago and has grown to become a multibillion-dollar business covering 17 markets with over 12,000 employees. Our people serve more than 200,000 medical facilities and work with over 450 clients, including the top 20 pharmaceutical companies in the world.

Job Description

• Represent company with various Regulatory Health Authorities (FDA, DOH, DDB, PDEA, BAI, etc.)
• Coordinates with various ZPC site Pharmacists on Licenses & Permits
• Ensures that all ZPC Sites are with updated and valid FDA License to Operate and License to Handle Dangerous Drugs.
• Identifies the products for reporting and uploading in Electronic Drug Monitoring Price System (EDPMS)
• Validates the data uploaded data in EDPMS.
• Prepares and submits initial, renewal, notification and variation application of License to Handle, Local Purchase Permit and/ or any other permit with PDEA.
• Coordinate, monitor and update validity and completeness of information of Clients’ various licenses such as LTO (Importer/Distributor), LTH (PDEA), and product licenses (including Certificates of Product Registrations, Notifications and/or Promo Permits of various Clients’ products)
• Review and approves New Product Information Sheet (NPIS) and MDRF to update the validity of Product Maintenance
• Reviews and approves the request for new and existing Customers LTO in the system.
• Execute key regulatory actions to support business requirements
• Ensure adherence to current and new regulations
• Cascade relevant and new regulations from governing bodies
• Ensure database, reports, trackers are updated and provided on time
• Provide support to the Regulatory Affairs Director in terms of regulatory strategy and regulatory intelligence to ensure speed to market of products and compliance with regulatory guidelines.
• Create SOPs, process updates to support regulatory function.
• Active representation of the company with trade associations and ensure key company advocacies are pushed across.

Qualifications

• B.S Pharmacy graduate and Licensed Pharmacist
• At least 1 to 2 years experience in Regulatory Affairs

What we offer

• We are committed to fostering an inclusive environment where our employees can learn, grow, and achieve shared success.
• We champion diversity, equity, and inclusion, ensuring every individual feels valued, respected, and treated fairly.
• As a leading multi-market healthcare solutions provider, we empower our employees to gain comprehensive knowledge and expertise in the dynamic healthcare industry across the region.
• Enjoy the flexibility to effectively balance your work and personal life while taking charge of your career journey through our empowering growth opportunities.
• Our Total Rewards program is designed to support your overall well-being in every aspect.

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