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Compliance Expert

2 weeks ago

Singapore beBeeRegulatory Full time $100,000 - $150,000
Job Description:

At our organization, we are committed to delivering high-quality products that meet regulatory standards. Our team of researchers and clinical experts utilizes clinic feedback from practitioners, scientifically researched literature, and top-notch manufacturing as the foundation for all our products.

We are seeking a meticulous and experienced Quality & Regulatory Affairs Specialist to join our team and ensure regulatory compliance, uphold product quality, and oversee vigilance reporting for all of our marketed products.

The ideal candidate will be responsible for handling and managing local annual GDPMDS and GDP inspection; supporting inspection readiness. They will maintain and manage all controls of documents and records. Additionally, they will manage and maintain local GDPMDS and GDP SOP and system records, including but not limited to all product complaints, returns, disposal, internal inspection/audit, deviation, CAPA management, etc.

The successful candidate will also perform personnel training to ensure regulatory and quality compliance. They will manage new and existing supplier management activities and provide regulatory support in RA activities.

For this role, we are looking for someone who:

  • Holds a Bachelor's degree in Life Sciences, Pharmacy, or a related discipline
  • Has at least 2 years of experience in pharmaceutical or medical device QA or RA, with some exposure to PV
  • Is familiar with Singapore HSA regulations, including Health Supplements Guidelines, Medical Device Regulations, and GDP
  • Has experience in SOP writing, inspection preparation, and Quality Management Systems (QMS)
  • Demonstrates strong documentation, regulatory filing, and communication skills
  • Is eager to grow with the company and open to cross-functional learning and development
  • Is ready to take on more responsibilities within the Quality & Regulatory Affairs domain; training and mentorship provided
  • Is adaptable and willing to support the team with ad hoc tasks when required.


It's a bonus if you also have:

  • Knowledge or exposure to US FDA biologic regulations and pharmacovigilance systems
  • Experience in SME distribution companies or startup environments
  • Experience in preparing for inspection readiness


What We Offer:

  • Competitive salary and performance-based bonuses
  • Opportunities for professional growth and development
  • Coffee treats from our generous bosses
  • A team of hard-working colleagues who work hard and play hard