Regulatory Affairs Expert

5 days ago


Singapore K Full time

**About K**

K is a leading company in the pharmaceutical industry, dedicated to developing innovative products that meet the needs of our customers.

Job Description:

We are seeking a highly skilled Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for ensuring that our products comply with relevant regulations and guidelines.

Key Responsibilities:

  • Prepare, review, and submit 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 in the respective markets (Asia) by working closely with CROs and appointed pharmaceutical distributors' in-market RA team to meet business objectives.

Requirements:

  • Bachelor's degree in Pharmacy, Life Sciences, or a related field. Advanced degrees (e.g., MSc, PhD) are a plus.
  • Minimum of 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 successful drug licensing and product registration in Singapore.
  • Strong understanding of pharmaceutical product development, manufacturing, and quality systems.
  • Ability to work independently and manage multiple projects in a fast-paced environment.


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