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Global Regulatory Compliance Expert

1 week ago

Singapore WiseNet Asia Pte Ltd Full time
Regulatory Affairs Role

We are seeking an experienced Global Regulatory Compliance Expert to join our team. The successful candidate will be responsible for ensuring the compliance of our products with regulatory requirements.

Responsibilities:

  • Prepare and review high-quality regulatory documents, including new drug applications (NDAs), variations, renewals, and post-approval changes, in compliance with HSA requirements.
  • Ensure timely and accurate submission of regulatory filings to meet business objectives.

Additional Responsibilities:

  • Lead the end-to-end drug licensing process, including the preparation of product dossiers, labeling, and packaging materials.
  • Liaise with HSA and other regulatory authorities to address queries and facilitate the approval process.

Requirements:

  • Bachelor's degree in Pharmacy, Life Sciences, or a related field.
  • Advanced degrees (e.g., MSc, PhD) are a plus.
  • 7 years of experience in regulatory affairs within the pharmaceutical industry.

In-depth knowledge of HSA regulations, ICH guidelines, and ASEAN regulatory requirements. Proven track record of hands-on successful drug licensing and product registration in Singapore. Strong understanding of pharmaceutical product development, manufacturing, and quality systems. Excellent communication, negotiation, and interpersonal skills. Ability to work independently and manage multiple projects in a fast-paced environment.