Regulatory Affairs Manager (Medical/ Therapeutic/ JAPAC)

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

Additional Information

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.

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Company Intel

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