Pharmacist

LG Health Inc.; Pasig; On-site; PHP 420,000 - 600,000; Full time

Job summary

LG Health Inc. is seeking a Regulatory Affairs Pharmacist to oversee FDA Philippines product registrations and renewals. You will prepare submissions, coordinate with the FDA, and ensure regulatory compliance across labeling and packaging of pharmaceutical products.

The role requires a BS in Pharmacy with a valid PRC license and 6 months to 2 years of regulatory affairs experience. Attention to detail and strong organizational skills are essential.

Qualifications

• Bachelor of Science in Pharmacy required.
• Registered Pharmacist with a valid PRC license required.
• 6 months to 2 years of FDA product registration or regulatory affairs experience required.
• Knowledge of FDA Philippines requirements and procedures required.
• Familiarity with Certificate of Product Registration applications and renewals required.
• Knowledge of medicines, drug classifications, active pharmaceutical ingredients required.
• Familiarity with medicine labeling, packaging requirements, and regulatory documentation required.
• Strong attention to detail and ability to manage regulatory documents and deadlines required.

Responsibilities

• Process and facilitate the registration of pharmaceutical products with FDA Philippines.
• Prepare, review, and submit documentary requirements for product registration and renewal.
• Coordinate with FDA regarding applications, inquiries, and compliance requirements.
• Review medicine labels, product information, and packaging materials for regulatory compliance.
• Monitor application status and ensure timely submission of regulatory requirements.
• Maintain accurate records of product registrations and regulatory documents.
• Ensure products comply with applicable FDA regulations and standards.

Skills

Regulatory affairs

FDA Philippines

Documentation management

Attention to detail

Pharmacist (PRC)

Education

Bachelor of Science in Pharmacy

PRC license

Job description

About the role

Support the registration, renewal, and regulatory compliance of pharmaceutical products with FDA Philippines. This role manages regulatory documentation, coordinates with the FDA, and helps ensure that product submissions, labels, packaging, and supporting information meet applicable requirements and standards.

Key responsibilities

• Process and facilitate the registration of pharmaceutical products with FDA Philippines.

• Prepare, review, and submit documentary requirements for product registration and renewal.

• Coordinate with FDA regarding applications, inquiries, and compliance requirements.

• Review medicine labels, product information, and packaging materials for regulatory compliance.

• Monitor application status and ensure the timely submission of regulatory requirements.

• Maintain accurate records of product registrations and regulatory documents.

• Ensure that pharmaceutical products comply with applicable FDA regulations and standards.

What we're looking for

• Bachelor of Science in Pharmacy degree.

• Registered Pharmacist with a valid PRC license.

• Six months to two years of experience in FDA product registration or regulatory affairs.

• Knowledge of FDA Philippines requirements and procedures for pharmaceutical product registration.

• Familiarity with Certificate of Product Registration applications, renewals, and other regulatory submissions.

• Good knowledge of medicines, pharmaceutical products, drug classifications, generic and brand names, and active pharmaceutical ingredients.

• Knowledge of medicine indications, contraindications, dosage forms, strengths, and product specifications.

• Familiarity with medicine labelling, packaging requirements, and pharmaceutical documentation.

• Strong attention to detail, organisation, and the ability to manage regulatory documents and deadlines.