Pharmacy Regulatory Affairs Specialist

Zienac Pharmaceutical Trading; Parañaque; On-site; PHP 279,000 - 390,600; Full time

Job summary

A leading pharmaceutical company in Metro Manila is seeking a Regulatory Affairs Specialist. Responsibilities include ensuring compliance with FDA regulations, preparing documents for regulatory agencies, and reviewing product labeling for adherence to guidelines. The ideal candidate is a licensed pharmacist with excellent communication, organizational skills, and a strong understanding of pharmaceutical regulations. Immediate start is available.

Qualifications

• Licensed pharmacist is required.
• Strong understanding of pharmaceutical regulations and compliance requirements.
• Ability to work effectively both independently and in teams.

Responsibilities

• Ensure compliance with FDA regulations.
• Prepare and submit documents to regulatory agencies.
• Review product labeling and advertising materials for compliance.
• Monitor changes in regulatory policies and advise the company.
• Maintain accurate regulatory files and records.
• Evaluate technical documents for applications of LTO and Product Registration.
• Monitor warehouse storage conditions and recommend corrective actions.

Skills

Excellent Computer Skills

Excellent communication skills

Organizational skills

Technical skills

Ability to interpret regulatory guidelines

Problem-solving skills

Analytical skills

Attention to detail

Ability to work under pressure

Teamwork skills

Education

Degree in Pharmacy

Tools

Excel

Word

Powerpoint

Job description

A leading pharmaceutical company in Metro Manila is seeking a Regulatory Affairs Specialist. Responsibilities include ensuring compliance with FDA regulations, preparing documents for regulatory agencies, and reviewing product labeling for adherence to guidelines. The ideal candidate is a licensed pharmacist with excellent communication, organizational skills, and a strong understanding of pharmaceutical regulations. Immediate start is available.