Senior Regulatory CMC Scientist – Injectables

Viatris; Dublin; Hybrid; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Excellent career progression

Work-life balance initiatives

Bonus scheme

Health insurance

Pension

Job summary

Viatris, a global healthcare company, seeks a Regulatory Affairs professional to lead CMC regulatory strategies for injectable products. You will interpret requirements, prepare global submissions, and partner with Manufacturing, Quality, Supply Chain and Legal teams to ensure regulatory compliance.

The role emphasizes mentorship, knowledge sharing, and staying ahead of evolving regulatory expectations, with opportunities to influence global programs across regions.

Qualifications

• Bachelor's degree in a science-related discipline.
• Experience in Regulatory Affairs in the pharmaceutical industry.
• Hands‑on experience authoring post-approval CMC lifecycle management submissions.
• Hands‑on Regulatory CMC experience supporting injectable products.
• Strong knowledge of global regulatory requirements, particularly US regulations.
• Experience with injectable, parenteral or combination product submissions.
• Excellent written and verbal communication skills.
• Strong understanding of cGMP, CFR, USP, Ph. Eur. and FDA guidance.
• Experience collaborating across Regulatory Affairs, Manufacturing, Supply Chain, Quality, Commercial, Medical and Legal functions.
• TOPRA certification or RAC qualification preferred.

Responsibilities

• Develop and implement global CMC regulatory strategies for injectable products.
• Interpret 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 knowledge

US regulatory knowledge

Cross-functional collaboration

Project management

Regulatory documentation

Communication skills

Education

Bachelor's degree in science

Tools

TrackWise

Documentum

Microsoft Office

Job description

Viatris, a global healthcare company, seeks a Regulatory Affairs professional to lead CMC regulatory strategies for injectable products. You will interpret requirements, prepare global submissions, and partner with Manufacturing, Quality, Supply Chain and Legal teams to ensure regulatory compliance.

The role emphasizes mentorship, knowledge sharing, and staying ahead of evolving regulatory expectations, with opportunities to influence global programs across regions.