Global Regulatory Delivery & Submissions Specialist

528 Eli Lilly Asia Pacific SSC Sdn Bhd; Kuala Lumpur; Sur place; MYR 100 000 - 160 000; Plein temps

Résumé du poste

528 Lilly Asia Pacific SSC Sdn Bhd in Kuala Lumpur seeks a Regional Regulatory Associate to manage local and regional submission plans, develop Module 1 documents, and ensure timely regulatory filings across Asia Pacific.

You will coordinate post-approval activities, support affiliate regulatory teams, and act as SME for RIM processes, including training and data integrity, while aligning with global regulatory policies.

Qualifications

• Regulatory submission planning and execution knowledge.
• Understanding of drug development processes.
• Ability to implement improvements in complex processes.

Responsabilités

• Provide Regulatory, Submission Planning and Execution Expertise for all submission types.
• Manage submission planning data in RIM (eCTD publishing, content plans).
• Coordinate post-approval submissions and changes with cross-functional partners.
• Train and support affiliate regulatory teams on RIM system and processes.

Connaissances

Regulatory expertise

Drug development knowledge

Strategic & tactical planning

Cross-functional influence

Formation

Bachelor’s degree or higher in chemistry, biology, pharmacy or related field

Description du poste

528 Lilly Asia Pacific SSC Sdn Bhd in Kuala Lumpur seeks a Regional Regulatory Associate to manage local and regional submission plans, develop Module 1 documents, and ensure timely regulatory filings across Asia Pacific.

You will coordinate post-approval activities, support affiliate regulatory teams, and act as SME for RIM processes, including training and data integrity, while aligning with global regulatory policies.