Regulatory Affairs Specialist

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

About the role:

The Regulatory Affairs Specialist will ensure that products meet all necessary regulations and standards in target markets. This position will be responsible for managing the process of regulatory submissions, approvals, and compliance with all applicable laws and guidelines. They will work closely with cross-functional teams, including quality assurance, product development, and legal, to maintain and update all relevant documentation, procedures, and policies.

Key responsibilities:

• Preparing, submitting and filing of regulatory documents
• Evaluation and filing of New products registration dossiers of imported drug products to FDA in coordination with Foreign based Suppliers
• Ensuring the licenses of the Food and Drug Administration (FDA) are all valid and updated
• Facilitates and complies with FDA inspections
• Performs the duties of Responsible Pharmacist for Warehouse as per standards of WHO's Good Distribution and Good Storage Practice
• Acts as Quality Assurance officer
• Coordinating with the Sales Team for the new product being developed

Qualifications:

• Bachelor's degree in a related field such as life sciences, pharmacy, chemistry, or regulatory affairs
• A minimum of 2-3 years of experience in a regulatory affairs role, preferably within the pharmaceutical, medical device, or healthcare sector
• In-depth knowledge of regulatory frameworks, including but not limited to FDA, CE Marking, and other relevant industry-specific regulations
• Proven experience in preparing and submitting regulatory filings and managing product approvals
• Excellent written and verbal communication skills, with the ability to convey complex regulatory information clearly