Responsibilities:
- Supports JAPAC affiliates and Global Regulatory Affairs in Marketing Authorization (MA) related activities for the assigned projects
- Manages interface with Affiliate/Agency for key projects/issues, including direct/indirect negotiation with regulatory agencies.
- Implements regulatory strategies for assigned projects for countries in JAPAC region in line with area commercial priorities in conjunction with the Global Regulatory Lead and other RA sub-team colleagues as appropriate.
- Partners with JAPAC commercial area to ensure business needs are met.
- Represents the JAPAC regulatory function at sub-teams to present regulatory requirements or provide strategic input for the registration of products.
- Assesses scientific data provided by specialist units for registration purposes against JAPAC national and regional regulatory/clinical requirements, identifying gaps and developing mitigation strategies to address gaps.
- Manages lifecycle activities for the assigned projects to ensure regulatory requirements are me
Requirements:
- min. Bachelor Degree in any science related disciplines
- Possess 5-7 years prior experience in regulatory affairs, preferably from the pharmaceutical in an MNC
- Excellent interpersonal and communication skills
Interested candidate please send your resume to:
kate.leau(a)recruitexpress.com.sg
Subject: Regulatory Affairs Manager
EA Personnel: Kate Leau Wei Xuan (R1552331)
Company Registration No.: 99C4599
