Regulatory Pharmacist: Submissions, Labeling & Compliance

Suhitas Pharmaceuticals Inc.; Makati; Hybrid; PHP 600,000 - 800,000; Full time

Job summary

A leading pharmaceutical company in Makati is seeking a Regulatory Affairs Pharmacist. The role involves managing product registration, ensuring compliance with FDA regulations, and conducting reviews of product labels. The ideal candidate should have a Bachelor's degree in Pharmacy and 3-5 years of experience in regulatory affairs. This position may offer potential for remote work and requires attention to detail and strong organizational skills.

Qualifications

• Licensed Pharmacist with 2-3 years of related experience in the related field.
• In-depth knowledge of pharmaceutical regulations, guidelines, and submission procedures.
• Strong understanding of drug development, manufacturing processes, and quality standards.

Responsibilities

• Responsible for the company’s LTO application, renewal and variations.
• Handle product registration processes for Drugs, Medical Devices, Foods, Cosmetics.
• Prepare submissions of renewals of CPR’s, monitor deadlines and ensure timely submission.
• Conduct thorough reviews of product labels for compliance with FDA regulations.
• Monitor and encode Electronic Drug Price Monitoring System (EDPMS) by the DOH.

Skills

Regulatory guidelines understanding

Communication skills

Critical thinking

Attention to detail

Organizational abilities

Education

Bachelor’s degree in Pharmacy or a related field

Job description

A leading pharmaceutical company in Makati is seeking a Regulatory Affairs Pharmacist. The role involves managing product registration, ensuring compliance with FDA regulations, and conducting reviews of product labels. The ideal candidate should have a Bachelor's degree in Pharmacy and 3-5 years of experience in regulatory affairs. This position may offer potential for remote work and requires attention to detail and strong organizational skills.