Senior Regulatory CMC Scientist – Injectables

Biopharma Careers; Inverin; On-site; EUR 120,000 - 160,000; Full time

Benefits offered by this job

Health insurance

Pension

Bonus scheme

Excellent career progression

Job summary

Viatris in Ireland is seeking an experienced Regulatory Affairs professional to lead global CMC regulatory strategies for injectable products. You will interpret regulatory requirements, prepare submissions, and collaborate with manufacturing, QA and supply chain to support variations and changes.

The role requires a science degree, hands-on CMC experience, knowledge of US and global regulations, and strong communication.

Qualifications

• Bachelor's degree (or equivalent) in a science-related discipline.
• Experience working within 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 requirements, CFR, USP, Ph. Eur. and FDA guidance.

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, labeling, 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

Written communication

Project management

Cross-functional collaboration

Regulatory guidance

Regulatory knowledge

Education

Bachelor's degree in life sciences

Tools

TrackWise

Documentum

Job description

Viatris in Ireland is seeking an experienced Regulatory Affairs professional to lead global CMC regulatory strategies for injectable products. You will interpret regulatory requirements, prepare submissions, and collaborate with manufacturing, QA and supply chain to support variations and changes.

The role requires a science degree, hands-on CMC experience, knowledge of US and global regulations, and strong communication.