Regulatory Affairs Manager - Singapore - RECRUIT EXPRESS PTE LTD

Description

Job Scope

• Supports JAPAC RA affiliates and Global RA in Marketing Authorization (MA) and clinical development related activities for the assigned projects.
• Manages interface with internal and external regulatory and cross-functional stakeholders, including direct/indirect interaction 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 intercontinental commercial, market access and medical 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 for registration purposes against JAPAC national and regional regulatory/clinical requirements, identifying gaps and developing mitigation strategies to address gaps.
• Manages clinical development, clinical trial, new drug applications and lifecycle activities for the assigned projects to ensure regulatory requirements are met and optimal regulatory strategies are reached.

Requirement

• BS Degree in pharmacy, pharmacology, biology or related subject.
• Minimum 5 years' experience in Regulatory.
• In-depth knowledge of the regulatory requirements of the countries within the JAPAC region is preferred.
• Sensitivity/knowledge of JAPAC culture and ways of doing business is helpful.
• Proven interpersonal skills.
• Strong proven personal development and motivational skills.
• Proficiency in communicating strategic and tactical issues to management and relevant stakeholders.

Interested applicants, please email your updated CV to or WA for more information.

EA Personnel No: R

EA Personnel Name: Lim Ruo Yi, Rachel

Company Registration Number: Recruit Express Pte Ltd (99C4599)