Sr Associatemanager Job In Cork

Develop and manage global marketing authorization submission processes, collaborating with regulatory scientists to create and manage RIM submission content and provide guidance on CTD registration submissions.

Key Responsibilities:

• Lead CMC submission management process, providing knowledge of CMC regulatory requirements, ICH CTD, and evolving global agency standards.
• Partner with CMC RA Scientist to plan and prepare submission content for clinical studies and manufacturing process changes.
• Drive execution of submission planning for global registration and maintenance submissions.
• Triage Lilly affiliate inquiries and requests, consulting with CMC RA Scientist as needed.
• Implement and interpret global regulations and guidance, ensuring final document content and structure align with local regulatory requirements.

Requirements:

• Bachelor's Degree in a scientific or health sciences discipline (e.g., pharmacy, chemistry, or related scientific discipline).
• Knowledge of pharmaceutical drug development or industry-related experience preferred.

Preferred Qualifications:

• Drug development process or industry-related experience.
• Knowledge of Agency submission procedures and practices.
• Ability to operate and manage operational requirements in a regulated environment.
• Written, spoken, and presentation skills.
• Negotiation and influence skills.
• Attention to detail and ability to effectively prioritize.
• Proven effective teamwork skills; able to adapt to diverse interpersonal styles.

About Eli Lilly Cork:

Eli Lilly Cork is a global healthcare leader with a talented and diverse team of over 1,600 employees across 38 nationalities, delivering innovative solutions across various business service functions.