The primary function of the Senior Specialist, Regulatory Affairs (RA) is to act as the representative of the regulatory affairs organization to the JAPAC commercial organization for all aspects related to the assigned projects within the Aesthetics area. The incumbent will have knowledge of the regulatory requirements of the countries within the region. Under guidance, he/she will combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. The incumbent will also represent RA in any cross-functional initiatives being led out of the JAPAC commercial offices or the global RA organization.

Major Responsibilities:

· Manages devices products related lifecycle activities for the assigned projects to ensure regulatory requirements are met

· Supports JAPAC Area RA Lead, affiliates and Global Regulatory Affairs in variation related activities (i.e. regulatory assessment, etc.) for the assigned projects

· Implements regulatory strategies for the assigned projects for countries in JAPAC under supervision, in line with area commercial priorities and in collaboration with the Global Regulatory Lead and other RA sub-team colleagues.

• Represents the JAPAC regulatory function at sub-teams or client group meetings (i.e. commercial, R&D, CMC, etc.) to present regulatory requirements or provide strategic input for the registration of products.
• Interfaces with JAPAC cross functional teams as appropriate and partners with JAPAC commercial teams to ensure business needs are met.
• Represents the JAPAC regulatory function at sub-teams to present regulatory requirements and commercial interests on the Global Regulatory Product Team (GRPT) to ensure those are met.
• Ensures regulatory compliance for the assigned Assets/products. Implements remediation plan to address identified gaps, if any.
• Supports regulatory initiatives for JAPAC Area team.

Education / Experience Required:

• Min Degree in pharmacy, pharmacology, bioengineering or related subject.
• Min 5 years of regulatory affairs in medical devices

Salary range: $5.5K to $7K

1 year contract

Interested candidates, please forward your resume to kevynhuang@recruitexpress.com.sg

Consultant: Huang Jingsheng Kevyn (R1333338)

Recruit Express Pte Ltd (99C4599)