Global Regulatory CMC Lead — Injectables

Viatris; Dublin; Híbrido; EUR 90 000 - 120 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Excellent career progression opportuni

Work-life balance initiatives

Bonus scheme

Health insurance

Pension

Resumo da oferta

Viatris is seeking a Regulatory Affairs professional to lead global CMC regulatory strategies for injectable products. You will interpret requirements and guide stakeholders, preparing cross-border submissions and lifecycle management.

The role involves coordinating with regulatory, manufacturing, quality and supply chain teams, handling agency interactions, and mentoring colleagues while keeping up with evolving regulatory expectations.

Qualificações

• Bachelor's degree in a science-related discipline.
• Experience in Regulatory Affairs in the pharmaceutical industry.
• Hands-on experience authoring post-approval CMC lifecycle submissions.
• Regulatory CMC experience for injectable products.
• Strong knowledge of global regulatory requirements, esp. US.
• Experience with injectable/parenteral submissions.
• Excellent written and verbal communication in English.
• Understanding of cGMP, CFR, USP, Ph. Eur., FDA guidance.
• Collaboration across Regulatory Affairs, Manufacturing, Supply Chain, Quality, Legal.

Responsabilidades

• Develop and implement global CMC regulatory strategies for injectable products.
• Interpret regulatory requirements and provide risk-based guidance to stakeholders.
• Prepare and review global CMC submission documentation and lifecycle management.
• Support sites with regulatory strategies for variations and supplements.
• Ensure regulatory compliance through management of CMC activities and change controls.
• Collaborate with regional regulatory, labeling, quality, supply chain, and manufacturing teams.
• Provide responses to health authority queries and participate in meetings/inspections.

Conhecimentos

Regulatory knowledge

Communication

Project management

Cross-functional collaboration

Team leadership

Regulatory strategy

Formação académica

Bachelor's degree in science or related field

TOPRA certification or RAC qualification

Ferramentas

TrackWise

Documentum

Microsoft Office

Descrição da oferta de emprego

Viatris is seeking a Regulatory Affairs professional to lead global CMC regulatory strategies for injectable products. You will interpret requirements and guide stakeholders, preparing cross-border submissions and lifecycle management.

The role involves coordinating with regulatory, manufacturing, quality and supply chain teams, handling agency interactions, and mentoring colleagues while keeping up with evolving regulatory expectations.