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) - Sign in to view email

Recruitment Consultant (R2090579)

Manpower Staffing Services (S) Pte Ltd

EA Licence: 02C3423