Pharmaceutical Licensing Consultant
3 days ago
We are looking for an experienced Pharmaceutical Licensing Consultant to join our team. The successful candidate will be responsible for ensuring the compliance of our products with regulatory requirements.
Key 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.
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.
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