Provide tehcnical expertise and leadership in lifecycle management and local submission pipelines, including registrations, variations and renewals.
Ensure local processes are in compliance to global standards and regulatory frameworks
Cross-collaboration with internal and external stakeholders, contributing to the development of regulatory strategies in line with business objectives
Perform regulatory intelligence monitoring, analyzing changes and trends in the regulatory landscape locally and globally, communicating impact assessments to stakeholders to support development of regulatory strategies
Anticipate and resolve potential regulatory issues, working with cross-functional departments to provide response to questions from health authorities
The successful incumbent should have demonstrated success in regulatory submissions and registrations of therapeutic products and exhibit strong collaborative and cross-functional team working skills, developing good relationships with stakeholders to develop long-term regulatory strategy and to ensure regulatory compliance.
Requirements
Relevant Bachelor\'s Degree (Bachelor\'s Degree in Pharmacy is an added advantage)
At least 5 - 8 years of regulatory experience within the pharmaceutical industry with demonstrated success in product registrations
Strong interpersonal skills with great ability to influence
Driven, passionate and able to work independently
Next Steps
Interested applicants may apply with your latest CV in word format and we shall connect shortly for a confidential discussion on the excellent opportunity! Principal Consultant: Cheong Yee Yin | Registration Number: R22108633 | EA License Number: 17C8502
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