Global Regulatory Operations & IDMP Expert

Viatris; Dublin; On-site; EUR 60,000 - 80,000; Full time

Benefits offered by this job

Excellent career‑progression opportunities

Work‑life balance initiatives

Bonus scheme

Health insurance

Pension

Job summary

Viatris seeks a Senior Specialist in Global Regulatory Operations, located in Dublin, Ireland. This role involves monitoring global regulatory initiatives and ensuring compliance with pan-European regulations. You will be leading cross-functional teams and driving improvements in data management and processes.

The ideal candidate holds a Bachelor's degree, has strong knowledge of EU regulatory frameworks, and is adept with RIM systems. Benefits include career progression opportunities, health insurance, and a bonus scheme.

Qualifications

• Pharmaceutical industry experience, preferably in Regulatory Affairs or Operations.
• Experience with the eCTD structure and ability to interpret complex regulatory documentation.
• Comfortable working with complex systems and managing multiple projects simultaneously.

Responsibilities

• Monitor and interpret global regulatory initiatives, focusing on EU regulations.
• Lead collaboration to identify data owners and improve governance.
• Act as SME on regulatory data, partnering to maintain high-quality data.

Skills

Knowledge of EU regulatory frameworks

Collaboration and communication skills

Organizational skills

Proficiency in Microsoft Word and Excel

Education

Bachelor’s degree (or equivalent)

Tools

Regulatory Information Management (RIM) systems

Document and data management platforms

Job description

Viatris seeks a Senior Specialist in Global Regulatory Operations, located in Dublin, Ireland. This role involves monitoring global regulatory initiatives and ensuring compliance with pan-European regulations. You will be leading cross-functional teams and driving improvements in data management and processes.

The ideal candidate holds a Bachelor's degree, has strong knowledge of EU regulatory frameworks, and is adept with RIM systems. Benefits include career progression opportunities, health insurance, and a bonus scheme.