Regulatory Affairs Pharmacist

SANIMED PHARMACEUTICALS INC; Makati; On-site; PHP 500,000 - 700,000; Full time

Job summary

SANIMED PHARMACEUTICALS INC in Metro Manila is seeking a Regulatory Affairs professional to ensure compliance with the Philippine FDA and other applicable regulations. The role focuses on preparing and submitting registration dossiers and license applications.

The ideal candidate has a B.S. in Pharmacy, 1–2 years of regulatory affairs experience, and strong documentation, analytical, and communication skills to support regulatory submissions and adherence to GMP and labeling requirements.

Qualifications

• Graduate of B.S. Pharmacy.
• 1–2 years of regulatory affairs or related pharmaceutical/food supplement experience.
• Experience with FDA product registration and CPR/LTO is an advantage.
• Proficient in Microsoft Office; Corel knowledge is a plus.
• Knowledge of Philippine FDA regulations, GMP and related laws.

Responsibilities

• Prepare, review, and submit product registration dossiers, license applications, renewals and variations.

Skills

Regulatory affairs

FDA regulations (Philippines)

Dossier submission

Documentation

Analytical skills

Communication skills

Organizational skills

MS Office

Corel applications

Education

B.S. Pharmacy

Tools

Microsoft Office

CorelDRAW

Job description

About the role

Manage regulatory affairs activities to ensure compliance with FDA and other applicable local international regulations.

Key responsibilities

• Prepare, review, and submit product registration dossiers, license applications, renewals and variations

About you

• Graduate of B.S. Pharmacy

• At least 1 - 2 years' work experience in the field of Regulatory Affairs or the pharmaceutical/ food supplement industry with a strong understanding of industry practices

• Experience with FDA product registration License to Operate (LTO), Certificate of Product Registration (CPR) and regulatory submissions is an advantage

• Proficient in Microsoft Office applications

• Knowledge in Corel applications is an advantage

• Strong knowledge of Philippine FDA regulations, GMP and applicable pharmaceutical laws

• Knowledge in ACTD dossier submission

• Familiarity with product registration, labelling requirements and regulatory documentation

• Up-to-date knowledge of relevant FDA regulations and guidelines

• Excellent documentation, analytical, organizational and communication skills