Global Regulatory Delivery & Excellence Specialist

Eli Lilly and Company; Petaling Jaya; On-site; MYR 367,000 - 530,000; Full time

Job summary

Eli Lilly and Company in Malaysia is seeking a Regional Regulatory Associate to manage local and regional submission management for Asia Pacific. You will work with Lilly affiliates and alliance partners to prepare Module 1 documents, coordinate submission planning, and maintain RIM data accuracy.

Key responsibilities include overseeing post-approval submission plans, coordinating with GRA-CMC and supply chain teams, and ensuring alignment on submission dates.

Qualifications

• Bachelor’s degree or higher in a technical discipline such as chemistry, biology, pharmacy or equivalent demonstrated industry experience.
• Knowledge of drug development process.
• Demonstrated ability to implement strategies and plans to improve complex processes.

Responsibilities

• Provide Regulatory, Submission Planning and Execution Expertise of all submission types.
• Manage planning and tracking submission-level data in RIM for the affiliate and ensure RIM data is correct for Right-to-Operate submissions.
• Prepare local Module 1 documents in RIM per appropriate regional submission and route for appropriate review and approval in collaboration with Lilly Affiliate Regulatory and/or Alliance Managers/Associates.
• Manage submission package compilation and non-eCTD publishing work in RIM submission content plans.
• Coordinate with affiliate and regional regulatory leaders to align on next-best submission date and escalate issues affecting timelines.
• Conduct impact assessment of local regulation changes and manage submission requirements and templates for assigned countries in central systems (R-Cubed/RIM templates).
• Collaborate with cross-functional partners to achieve optimal post-approval submission plans and ensure compliant product availability.
• Create RIM Renewal and Manufacturing Site Registration/Renewal records and maintain submission dates.

Skills

Regulatory submissions

Cross-functional collaboration

Veeva Vault/RIM

Project management

Regulatory policy

Education

Bachelor’s degree in chemistry, biology, pharmacy

Tools

Veeva Vault

RIM

Job description

Eli Lilly and Company in Malaysia is seeking a Regional Regulatory Associate to manage local and regional submission management for Asia Pacific. You will work with Lilly affiliates and alliance partners to prepare Module 1 documents, coordinate submission planning, and maintain RIM data accuracy.

Key responsibilities include overseeing post-approval submission plans, coordinating with GRA-CMC and supply chain teams, and ensuring alignment on submission dates.