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Regulatory Affairs Specialist

2 weeks ago

Singapore WiseNet Asia Pte Ltd Full time
About Us

WiseNet Asia Pte Ltd is a reputable pharmaceutical company headquartered in China.

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

Key Responsibilities:

  • Regulatory Submissions: 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 to meet business objectives.

Drug Licensing:

  • 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.

Compliance and Strategy:

  • Stay updated on changes in regulatory guidelines and ensure company practices align with local and international regulations.
  • Provide regulatory intelligence and strategic advice to internal stakeholders to support product development and commercialization.

Cross-Functional Collaboration:

  • Work closely with R&D, Quality Assurance, Pharmacovigilance, and Commercial teams to ensure regulatory requirements are integrated into product development and marketing strategies.
  • Support the preparation of regulatory responses during audits and inspections.

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.