Associate Director - Global Core Labeling (Regulatory Affairs)

Scientificjobs; Cork; On-site; EUR 90,000 - 130,000; Full time

Job summary

A leading global healthcare company in Cork is seeking an Associate Director for Global Core Labeling in Regulatory Affairs. This key role involves leading the development of global labeling documents and ensuring timely submissions, as well as optimizing processes to enhance compliance and collaboration across teams.

Qualifications

• At least 2 years of experience in regulatory affairs or drug development.
• Knowledge of drug development and regulatory strategies.
• Strong communication, teamwork, and organizational skills.

Responsibilities

• Provide leadership for global labeling strategy.
• Lead the development and maintenance of core labeling documents.
• Collaborate with global teams to support labeling strategies.

Skills

Communication

Teamwork

Organizational skills

Education

Bachelor's degree in a scientific or health sciences discipline

Job description

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Associate Director - Global Core Labeling (Regulatory Affairs), Cork

Location: Cork, Ireland

Job Category: Other

EU work permit required: Yes

Job Reference: 3ca01bc728a1

Job Views: 3

Posted: 24.06.2025

Expiry Date: 08.08.2025

Job Description:

Associate Director - Global Core Labeling (Regulatory Affairs)

Our client is a global healthcare leader with employees around the world who work to discover and bring life-changing medicines to those who need them.

They are seeking a Global Labelling Lead at the Associate Director level to join their Global Business Centre. The role involves leading the development and maintenance of global labeling, including core labeling documents related to drugs, devices, CMC, and packaging components. The Associate Director ensures the timely delivery of global labeling to affiliates for simultaneous submissions and leads updates throughout the product lifecycle.

Primary Responsibilities:

• Provide leadership for global labeling strategy to facilitate simultaneous global submissions.
• Implement initiatives related to global labeling strategy.
• Serve as the global labeling representative for assigned products.

Core Labeling Development and Maintenance:

• Lead the development and maintenance of core labeling documents.
• Coordinate approval processes with relevant committees.
• Communicate labeling updates to global affiliates.

Labeling Process Excellence:

• Optimize core labeling processes and manage exception requests.
• Support compliance assessments and continuous improvement.

Lead/Influence/Partner:

• Collaborate with global teams and partners to support labeling strategies.
• Ensure timely communication and alignment of labeling documents.

Minimum Qualification Requirements:

• Bachelor’s degree in a scientific or health sciences discipline.
• At least 2 years of experience in regulatory affairs or drug development.
• Knowledge of drug development and regulatory strategies.
• Strong communication, teamwork, and organizational skills.