Global CMC Regulatory Manager - Injectables

1100 Mylan Pharmaceuticals Inc.; Galway; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Health insurance

Pension

Bonus scheme

Career progression

Job summary

Viatris seeks a Regulatory Affairs professional to develop and implement global CMC regulatory strategies for injectable products. You will prepare and analyse global submissions, support variations and change controls, and liaise with regional regulatory, labeling, quality, and manufacturing teams.

The role requires a science degree and extensive experience in regulatory affairs, especially CMC for injectables, knowledge of US regulations, and proficiency with TrackWise and Documentum.

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, including preparation and review of regulatory documentation.
• 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 Microsoft Office applications and regulatory systems such as TrackWise and Documentum.
• Topra certification or RAC qualification preferred.

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 Affairs

CMC

Injectables

Written & Verbal Communication

Project Management

US Regulations

Education

Bachelor's degree in a science-related discipline

Tools

TrackWise

Documentum

Job description

Viatris seeks a Regulatory Affairs professional to develop and implement global CMC regulatory strategies for injectable products. You will prepare and analyse global submissions, support variations and change controls, and liaise with regional regulatory, labeling, quality, and manufacturing teams.

The role requires a science degree and extensive experience in regulatory affairs, especially CMC for injectables, knowledge of US regulations, and proficiency with TrackWise and Documentum.