Job Description

Regulatory Affairs Manager (JAPAC/ Neuroscience/ Therapeutic)12-Months Contract (Renewable)
Location: Buona Vista
Salary: Up to $8000 depending on experienceOur client is a global, research-based biopharmaceutical company, combines the focus and passion of a leading-edge biotech with the expertise and capabilities of a long-established pharmaceutical leader to develop and market advanced therapies that address some of the world\'s most complex and serious diseases.Primary Function / Primary Goals / Objectives:

• The primary function of the Manager, Regulatory Affairs (RA) is 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.

Major 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
• Proficiency in communicating strategic and tactical issues to management and relevant stakeholders.
• Teleconferences (outside of office hours)

Lim Pey Chyi (Apple) -
Recruitment Consultant (R2090579)
Manpower Staffing Services (S) Pte Ltd
EA Licence: 02C3423Apple, Pey Chyi Lim EA License No.: 02C3423 Personnel Registration No.: R2090579Please note that your response to this advertisement and communications with us pursuant to this advertisement will constitute informed consent to the collection, use and/or disclosure of personal data by ManpowerGroup Singapore for the purpose of carrying out its business, in compliance with the relevant provisions of the Personal Data Protection Act 2012. To learn more about ManpowerGroup\'s Global Privacy Policy, please visit https://www.manpower.com.sg/privacy-policy

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