Regulatory Affairs Specialist (Pharma Mnc/1 Year Contract)

Responsibilities Support Regional Regulatory Leads in creating regulatory strategies for assigned pipeline products for Asia, in coordination with the country RA leads.
For non-pipeline products, may be assigned to more actively support and prepare strategies for life cycle management activities Providing documentation to country RA leads as required to drive their new NDA and life-cycle management submissions.
Coordinate submission requirements between country RA leads and other teams as applicable (Global Regulatory Leads, manufacturing sites, and other functional leads).
Support the establishment and implementation of local and regional regulatory processes and SOPs.
Provide overall administrative support to Regional Regulatory Leads, including, but not limited to, archiving, reporting, system updating, payment processing, etc.
Requirements Bachelors degree in a life science discipline such as biology, chemistry, pharmacy, or toxicology.
Minimum of 2 years experience in Regulatory Affairs within Asia region, with a proven track record of success in developing, submitting, and managing regulatory submissions.
Experience with regulatory project management, including the ability to plan, execute, and track projects to successful completion.
Strong understanding of the medicinal and/or medical device legislation and guidelines of the Asia region relevant for the scope of products/projects.
KL Sentral, 5 days week, 1 year contract with full benefits, subject to extension.
Job Reference: QYXXY835 All Successful candidates can expect a very competitive remuneration package and a comprehensive range of benefits.