Regulatory Affairs Manager: Dossier & Labelling Strategy

Eli Lilly and Company; Petaling Jaya; On-site; MYR 120,000 - 160,000; Full time

Job summary

A global healthcare leader located in Selangor is looking for a Regulatory Affairs professional to manage regulatory operations and collaborate with business partners. The ideal candidate will possess a Bachelor's degree and strong skills in project management, compliance, and communication. Responsibilities include managing submission plans, ensuring document integrity, and overseeing regulatory compliance. This role requires excellent teamwork and problem-solving abilities, providing a critical link between the company and its partners.

Qualifications

• Bachelor's degree or equivalent in a relevant scientific subject.
• Team working skills with a focus on results.
• Ability to adapt to challenging situations.
• Good knowledge of written and spoken English.
• Analytical, problem solving and negotiation skills.
• Good communication skills.
• Project management skills.
• Strong knowledge of quality systems.

Responsibilities

• Manage regulatory operational and technical aspects for business partners.
• Align on submission plans and monitor progress.
• Oversee labelling projects to ensure timely implementation.
• Build and maintain strong working relationships with partners.
• Ensure compliance with regulatory requirements.

Skills

Team working skills

Adaptability

Computer/IT skills

Written and spoken English

Analytical skills

Problem solving skills

Negotiation skills

Communication skills

Project management skills

Quality systems knowledge

Education

Bachelor's degree in a relevant scientific subject

Job description

A global healthcare leader located in Selangor is looking for a Regulatory Affairs professional to manage regulatory operations and collaborate with business partners. The ideal candidate will possess a Bachelor's degree and strong skills in project management, compliance, and communication. Responsibilities include managing submission plans, ensuring document integrity, and overseeing regulatory compliance. This role requires excellent teamwork and problem-solving abilities, providing a critical link between the company and its partners.