Regulatory CMC Lead — Injectables & Global Strategy

Viatris; Inverin; On-site; EUR 85,000 - 125,000; Full time

Benefits offered by this job

Excellent career progression

Work-life balance initiatives

Bonus scheme

Health insurance

Pension

Job summary

Viatris is seeking a Senior Regulatory CMC professional to develop global regulatory strategies for injectable products and to guide cross-functional teams through submissions and lifecycle management.

The role requires strong knowledge of US and global regulatory requirements, experience with TrackWise and Documentum, and a proven track record in managing complex CMC programs within a pharmaceutical environment.

Qualifications

• Bachelor's degree (or equivalent) in a science-related discipline.
• Experience in Regulatory Affairs in the pharmaceutical industry.
• Hands-on experience authoring post-approval CMC lifecycle submissions.
• Hands-on Regulatory CMC experience with injectable products.
• Strong knowledge of global regulatory requirements, especially US regulations.
• Experience with injectable/parenteral products submissions.
• Excellent written/verbal communication and regulatory documentation skills.
• Knowledge of cGMP, CFR, USP, Ph. Eur. and FDA guidance.
• Cross-functional collaboration across Regulatory, Manufacturing, Quality, Supply Chain, Commercial and Legal functions.

Responsibilities

• Develop and implement global CMC regulatory strategies for injectable products.
• Interpret regulatory requirements and provide risk-based guidance to stakeholders.
• Prepare and analyse global CMC submission documentation and lifecycle activities.
• Support sites with regulatory strategies for variations and supplements.
• Ensure compliance through management of CMC activities and change controls.
• Collaborate with regional teams to support submissions and agency interactions.
• Provide responses to health authority queries and assist in meetings.

Skills

Regulatory strategy

Communication

Cross-functional collaboration

Regulatory documentation

Project management

Team leadership

English technical writing

Education

Bachelor's degree in science

Tools

TrackWise

Documentum

Microsoft Office

Job description

Viatris is seeking a Senior Regulatory CMC professional to develop global regulatory strategies for injectable products and to guide cross-functional teams through submissions and lifecycle management.

The role requires strong knowledge of US and global regulatory requirements, experience with TrackWise and Documentum, and a proven track record in managing complex CMC programs within a pharmaceutical environment.