Responsibilities:
- Implements regulatory strategies for the assigned projects for countries in Japan and APAC
- Partners with Intercontinental commercial teams to ensure business needs are met.
- Represents the Japan and APAC regulatory function at sub-teams to present regulatory requirements and commercial interests
- Represents the JAPAC regulatory function at sub-teams or client group meetings to present regulatory requirements or provide strategic input for the registration of products.
- Interfaces with Clinical Development as appropriate
- Assesses scientific data provided by specialist units for registration purposes, identifying gaps and developing mitigation strategies to address gaps
- Ensures effective presentation of data, complete and timely responses.
- Ensures regulatory compliance for the assigned compounds/products. Implements remediation plan to address identified gaps, if any.
Requirements:
- Minimum Degree in related courses and above
- MIn 2- 3 years of regualatory experience in pharma MNCs
- Able to start immediate or within short notice
Attn: Senior/Regulatory Affairs Specialist (Pharma MNC, $6800) #HKA
We regret to inform that only shortlisted candidates will be contacted
EA Personnel: Kayley Ng Yin Yi (R1762843)
Company EA Registration Number: Recruit Express Pte Ltd (99C4599)
