Manager - Regulatory Affairs (Pharmaceutical/CRO)

Michael Page International Pte Ltd - One Raffles Place Tower 2 #09-61 Singapore 048616

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.
 


Post Date 05 December 2017
End Date 04 January 2018

Other vacancies of Michael Page International Pte Ltd

Group Accountant- Real Estate Listed Company

Group Accountant- Real Estate Listed Company

Page Personnel (a division of Michael Page International Pte Ltd) - Central
15 Dec - 2:31 PM
Finance Manager - North Singapore

Finance Manager - North Singapore

Page Personnel (a division of Michael Page International Pte Ltd) - Central
15 Dec - 9:02 AM
Regional Talent Management Manager (APAC) - B2C

Regional Talent Management Manager (APAC) - B2C

Michael Page International Pte Ltd - East
15 Dec - 8:47 AM
QA Manager (Machine Tool)

QA Manager (Machine Tool)

Michael Page International Pte Ltd - Singapore
15 Dec - 8:45 AM
Global Group IT Manager (SAP Basis)

Global Group IT Manager (SAP Basis)

Michael Page International Pte Ltd - West
15 Dec - 8:38 AM
Regional IT Support Specialist

Regional IT Support Specialist

Page Personnel (a division of Michael Page International Pte Ltd) - Central
15 Dec - 8:35 AM
Regional Inside Sales representative - Marine Industry

Regional Inside Sales representative - Marine Industry

Page Personnel (a division of Michael Page International Pte Ltd) - Central
15 Dec - 8:29 AM
Supervisor - Luxury Lifestyle Brand

Supervisor - Luxury Lifestyle Brand

Page Personnel (a division of Michael Page International Pte Ltd) - Singapore
15 Dec - 8:26 AM
Office Administrator cum Receptionist

Office Administrator cum Receptionist

Page Personnel (a division of Michael Page International Pte Ltd) - Central
15 Dec - 8:19 AM
APAC Infrastructure Operations Manager

APAC Infrastructure Operations Manager

Michael Page International Pte Ltd - Central
14 Dec - 4:29 PM
Innovation Manager (Management Consulting;Specialty Chemicals)

Innovation Manager (Management Consulting;Specialty Chemicals)

Michael Page International Pte Ltd - Singapore
14 Dec - 4:24 PM
Assistant Vice President - Human Resources - Hospitality Space

Assistant Vice President - Human Resources - Hospitality Space

Michael Page International Pte Ltd - North
14 Dec - 4:10 PM
Key Account Executive - Beauty industry

Key Account Executive - Beauty industry

Page Personnel (a division of Michael Page International Pte Ltd) - Central
14 Dec - 4:01 PM
Key Account Executive - Horeca channel

Key Account Executive - Horeca channel

Page Personnel (a division of Michael Page International Pte Ltd) - Central
14 Dec - 3:57 PM
FIX Protocol Project Manager

FIX Protocol Project Manager

Michael Page International Pte Ltd - Central
14 Dec - 3:53 PM
IT Business Partner - Sales & Marketing Projects

IT Business Partner - Sales & Marketing Projects

Michael Page International Pte Ltd - Central
14 Dec - 3:49 PM
Tax Assistant (Contract to Permanent)

Tax Assistant (Contract to Permanent)

Page Personnel (a division of Michael Page International Pte Ltd) - Central
14 Dec - 9:55 AM
Quality Assurance Manager

Quality Assurance Manager

Michael Page International Pte Ltd - Singapore
14 Dec - 9:47 AM
Project Manager (Application)

Project Manager (Application)

Michael Page International Pte Ltd - Singapore
14 Dec - 9:04 AM
Manager Pre-Sales (Infrastructure)

Manager Pre-Sales (Infrastructure)

Michael Page International Pte Ltd - Singapore
14 Dec - 8:49 AM

Company Profile

Michael Page International Pte Ltd

Michael Page International Pte Ltd

Singapore - Across Singapore

Michael Page International is a leading professional recruitment consultancy specialising in the recruitment of permanent, contract and temporary positions on behalf of the world¡¦s top employers. The Group operates through 166 offices in 34 countries worldwide and over 5,000 employees worldwide. First established in London in 1976, we've been bringing job seekers and employers together for more than 30 years.