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[Expired] Manager - Regulatory Affairs (Clinical Research Organisation)

MICHAEL PAGE INTERNATIONAL (SINGAPORE)
Posted On :13 Dec 2017

 

Job Summary

  • Salary:   Undisclosed
  • Work Type: Permanent / Full Time
  • Min. Education Level: Degree
  • Field of Study: Pharmacy
  • Years of Experience: 6
  • Skills: Regulatory affairs manager, Clinical Research

Job Descriptions

Lead regulatory affairs for a rapidly growing Clinical Research Organisation

Client Details

One of Asia's largest Clinical Research organisations, the company provides end to end solutions to some of most renowned pharmaceutical and biotechnology organisations in the world. Having a well established presence in Singapore, they are now looking to significantly grow their operations.

Description

  • Represent the company interests with local government agencies, industry associations and/or other organisations to negotiate legislation and regulations
  • Maintain awareness of the regional regulatory requirements so as to assess the impact and implementation of required company compliance with all regulations
  • Monitor and interpret local regulatory issues and trends that will impact the clinical development environment of clinical trials, product registration/variations/renewals
  • Develop and maintain a database of regional regulatory requirements
  • Responsible as functional leader, to work collaboratively with other operational project teams to ensure seamless cross-functional communication/documentation and that the project related activities
  • Provide regulatory consultation and strategy planning for clinical trials, product registration/variations/renewals  of medicinal products, medical devices and/or biologics as required

Profile

  • Minimum 5 years direct experience in regional regulatory related work for clinical trials and registration of medicinal/device/biologic products, as well as in pricing, license-in activities
  • Experienced in coordination and preparation for site/CEO audit
  • Good understanding of cross-functional processes, clinical trial processes and the regional regulatory environment
  • Good organisationally, leadership, negotiation and interpersonal skills

Job Offer

An opportunity to work with a leading clinical research organisation

To apply online please click the 'Apply' button below. For a confidential discussion about this role please contact Tushar Dadhwal on +65 6419 5938.