Regulatory CMC Sciences Manager – Injectables (Dublin)

Viatris; Dublin; Hybrid; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Health insurance

Pension plan

Bonus scheme

Job summary

Viatris is seeking a Manager Regulatory CMC Sciences (Injectables) in Dublin to lead global regulatory strategies for injectable products, interpret requirements, and prepare lifecycle submissions. You will support manufacturing sites with regulatory strategies for variations and ensure compliance through effective change control processes.

The role requires strong cGMP knowledge, hands-on regulatory CMC experience with injectables, and collaboration across Regulatory, Manufacturing, Quality,

Qualifications

• Bachelor's degree (or equivalent) in a science-related field.
• Experience in Regulatory Affairs in pharma.
• Hands-on post-approval CMC lifecycle submissions for injectable products.
• Knowledge of global regulatory requirements, esp. US rules.
• Familiarity with cGMP, CFR, USP, Ph. Eur. and FDA guidance.

Responsibilities

• Develop and implement global CMC regulatory strategies for injectable products.
• Interpret regulatory requirements and provide risk-based guidance to stakeholders.
• Prepare, review and analyse global CMC submissions and lifecycle activities.
• Support sites with regulatory strategies for variations and supplements.
• Lead regulatory interactions and participate in agency inspections as required.
• Mentor colleagues and contribute to capability development.
• Maintain awareness of emerging regulatory requirements and industry trends.

Skills

Regulatory affairs

CMC

injectable submissions

Regulatory communication

cGMP knowledge

TrackWise

Documentum

project management

people management

Education

Bachelor's degree in science

Tools

TrackWise

Documentum

Job description

Viatris is seeking a Manager Regulatory CMC Sciences (Injectables) in Dublin to lead global regulatory strategies for injectable products, interpret requirements, and prepare lifecycle submissions. You will support manufacturing sites with regulatory strategies for variations and ensure compliance through effective change control processes.

The role requires strong cGMP knowledge, hands-on regulatory CMC experience with injectables, and collaboration across Regulatory, Manufacturing, Quality,