Regulatory Affairs Specialist: FDA & CE Compliance

VItamax Prime Trading Inc; Pasig; On-site; PHP 420,000 - 660,000; Full time

Job summary

VItamax Prime Trading Inc is seeking a Regulatory Affairs Specialist to ensure products meet regulatory standards across target markets. You will manage regulatory submissions, approvals, and ongoing compliance, coordinating with quality, development, and legal teams to keep documentation current.

The role requires a life sciences or pharmacy degree with 2–3 years in regulatory affairs, knowledge of FDA and CE Marking, and the ability to prepare filings and obtain approvals.

Qualifications

• Knowledge of regulatory frameworks including FDA and CE Marking.
• Experience preparing and submitting regulatory filings and managing approvals.
• Excellent written and verbal communication skills for complex regulatory information.

Responsibilities

• Preparing, submitting and filing of regulatory documents.
• Evaluation and filing of new product registration dossiers with FDA in coordination with foreign suppliers.
• Ensuring FDA licenses are valid and updated.
• Facilitates and complies with FDA inspections.
• Acts as Responsible Pharmacist for Warehouse per WHO guidelines.
• Coordinating with Sales for new product development.

Skills

Regulatory knowledge

Regulatory filings

Communication skills

Pharma domain knowledge

Education

Bachelor's degree in Life Sciences / Pharmacy

Job description

VItamax Prime Trading Inc is seeking a Regulatory Affairs Specialist to ensure products meet regulatory standards across target markets. You will manage regulatory submissions, approvals, and ongoing compliance, coordinating with quality, development, and legal teams to keep documentation current.

The role requires a life sciences or pharmacy degree with 2–3 years in regulatory affairs, knowledge of FDA and CE Marking, and the ability to prepare filings and obtain approvals.