Regulatory Affairs Specialist (Pharma MNC/1 year contract)

People Profilers; Kuala Lumpur; On-site; MYR 48,000 - 72,000; Full time

Job summary

An established industry player is seeking a Regulatory Affairs Specialist to support regulatory strategies for pipeline products in Asia. This role involves coordinating submissions, managing documentation, and providing administrative support to Regional Regulatory Leads. With a focus on life sciences, the position offers a one-year contract with full benefits and the potential for extension. If you have a strong background in regulatory affairs and project management, this is a fantastic opportunity to contribute to impactful projects in the pharmaceutical sector.

Benefits

Full benefits

Competitive remuneration package

Qualifications

• 2+ years in Regulatory Affairs with a successful track record.
• Strong understanding of Asia's medicinal legislation and guidelines.

Responsibilities

• Support regulatory strategies for pipeline products in Asia.
• Provide documentation for NDA and life-cycle management submissions.
• Admin support for Regional Regulatory Leads, including reporting and payment processing.

Skills

Regulatory Affairs

Project Management

Documentation

Life Cycle Management

Education

Bachelor's degree in life sciences

Job description

Regulatory Affairs Specialist (Pharma MNC/1 year contract)

Job Description:

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.
• Provide 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

• Bachelor's 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.

Work Location: 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.

We regret that only shortlisted candidates will be notified.