Global Regulatory CMC Lead – Injectables

Viatris; Connacht; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Career progression

Work-life balance

Bonus scheme

Health insurance

Pension

Job summary

Viatris is seeking a Regulatory Affairs professional to develop and implement global CMC regulatory strategies for injectable medicines. You will interpret requirements, provide risk-based guidance, prepare submissions, and support variations across manufacturing sites.

The role requires collaboration with regulatory, labeling, quality, supply chain and legal teams, mentoring colleagues, and staying ahead of evolving regulations.

Qualifications

• Experience in Regulatory Affairs within the pharmaceutical industry.
• Hands-on experience authoring post-approval CMC lifecycle submissions.
• Experience supporting injectable products.
• Strong knowledge of global regulatory requirements, particularly US regulations.
• Excellent written and verbal communication skills.
• Strong understanding of cGMP requirements, CFR, USP, Ph. Eur. and FDA guidance.
• Experience collaborating across Regulatory Affairs, Manufacturing, Supply Chain, Quality, Commercial, Medical and Legal functions.
• Proficiency with TrackWise and Documentum.

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

Regulatory strategy

CMC regulatory

Cross-functional collaboration

Project management

Regulatory submissions

Communication skills

Education

Bachelor's degree in a science-related discipline

Tools

TrackWise

Documentum

Regulatory databases

Job description

Viatris is seeking a Regulatory Affairs professional to develop and implement global CMC regulatory strategies for injectable medicines. You will interpret requirements, provide risk-based guidance, prepare submissions, and support variations across manufacturing sites.

The role requires collaboration with regulatory, labeling, quality, supply chain and legal teams, mentoring colleagues, and staying ahead of evolving regulations.