Senior Regulatory CMC Lead – Injectables

Viatris; Dublin; On-site; EUR 100,000 - 140,000; Full time

Benefits offered by this job

Health insurance

Pension

Bonus scheme

Job summary

Mylan Teoranta in Ireland seeks an experienced Regulatory Affairs professional to develop and implement global CMC strategies for injectable products. You will interpret regulatory requirements and provide risk-based guidance to stakeholders.

You will prepare and review global lifecycle submissions, support variations, and collaborate with manufacturing, quality, and supply chain teams to ensure compliance.

Qualifications

• Bachelor's degree in a science-related discipline.
• Experience in Regulatory Affairs within the pharmaceutical industry.
• Authoring post-approval CMC submissions.
• Regulatory CMC experience for injectables.
• Knowledge of global regulatory requirements including US.
• Experience with cross-functional collaboration.

Responsibilities

• Develop and implement global CMC regulatory strategies for injectable products.
• Interpret and communicate regulatory requirements and provide risk-based regulatory guidance to stakeholders.
• Prepare, review and analyse global CMC submission documentation and lifecycle management activities.
• Support manufacturing sites with regulatory strategies and documentation for variations and supplements.
• Ensure regulatory compliance through effective management of CMC activities and change controls.
• Collaborate with regional regulatory, labelling, quality, supply chain and manufacturing teams to support submissions and agency interactions.
• Provide responses to health authority queries and participate in regulatory authority meetings and inspections as required.
• Act as a regulatory subject matter expert within cross-functional project teams.
• Mentor colleagues and contribute to knowledge sharing and capability development.
• Maintain awareness of emerging regulatory requirements and industry trends, communicating impacts to relevant stakeholders.

Skills

Project management

Excellent written and verbal

Cross-functional collaboration

Regulatory strategy development

Attention to detail

Education

Bachelor's degree in a science-related field

Tools

TrackWise

Documentum

Microsoft Office

Job description

Mylan Teoranta in Ireland seeks an experienced Regulatory Affairs professional to develop and implement global CMC strategies for injectable products. You will interpret regulatory requirements and provide risk-based guidance to stakeholders.

You will prepare and review global lifecycle submissions, support variations, and collaborate with manufacturing, quality, and supply chain teams to ensure compliance.