Regulatory Affairs Manager (Medical/ Therapeutic/ JAPAC)

Regulatory Affairs Manager (Medical/ Therapeutic/ JAPAC) 12-Months Contract (Renewable) Location: The Metropolis Tower One Salary: Up to $9,000 depending on experience Completion Bonus Our client is a global biopharmaceutical company focused on developing innovative medicines and therapies to improve patient outcomes and quality of life worldwide . Primary Function: • To act as the representative of the regulatory affairs organization from JAPAC for all aspects related to the assigned projects within the Neuroscience, Eye Care and Specialty therapeutic area. • Having the knowledge of the regulatory requirements of the countries within the region. The incumbent will also represent RA in cross-functional initiatives assigned.   Responsibilities: • 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. Requirements: • 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 • Sensitivity/knowledge of JAPAC culture and ways of doing business is helpful. • Proficiency in communicating strategic and tactical issues to management and relevant stakeholders. Lim Pey Chyi (Apple) - Apple.lim@manpower.com.sg Recruitment Consultant (R2090579) Manpower Staffing Services (S) Pte Ltd EA Licence: 02C3423