Regulatory Affairs Officer/ QA Staff

SINGAPORE PHARMAWEALTH LIFESCIENCES, INC.; San Pablo; On-site; PHP 300,000 - 420,000; Full time

Job summary

Singapore Pharmawealth Lifesciences, Inc. is seeking a Regulatory Affairs Assistant to prepare, submit, and monitor product registrations, variations, and renewals.

The role ensures compliance with FDA and other regulatory authorities and requires basic knowledge of regulatory processes and strong MS Office skills. Fresh graduates are welcome, with a keen interest in regulatory affairs, quality assurance, and GMP compliance.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, or allied sciences.
• Fresh graduates welcome to apply.
• Basic knowledge of FDA regulatory requirements and processes.

Responsibilities

• Prepare, submit, and monitor product registrations, variations, renewals, and related regulatory documents.
• Ensure compliance with FDA and other regulatory authorities.
• Maintain accurate regulatory records and communicate with internal stakeholders.

Skills

Regulatory affairs

Attention to detail

Communication skills

Independent worker

Education

Bachelor's degree in Pharmacy, Chemistry, or allied sciences

Tools

Microsoft Office

Job description

Job Summary:

Responsible for the preparation, submission, and monitoring of product registrations, variations, renewals, notifications, licenses, certificates, and other regulatory documentation. Ensures the Company’s compliance with applicable regulatory and marketing requirements mandated by the FDA and other relevant regulatory authorities.

Qualifications:

• Graduate of a Bachelor's Degree in Pharmacy, Chemistry, or other allied sciences courses

• Experience is not required. Fresh graduates are welcome to apply.

• Possesses basic knowledge of FDA regulatory requirements and processes, including product registration, variations, batch notification, renewal of Certificate of Good Manufacturing Practice (cGMP), License to Operate (LTO), and other related regulatory affairs functions.

• Proficient in Microsoft Office applications: Word, Excel, PowerPoint, and Visio.

• Possesses good communication and interpersonal skills.

• Demonstrates attention to detail and can work effectively with minimal supervision

• Has a strong interest in pharmaceutical regulatory affairs, quality assurance, and GMP compliance.