Manager Regulatory CMC Sciences (Injectables)

Manager Regulatory CMC Sciences (Injectables)

Viatris

Inverin, Ireland

The Role & What You Will Be Doing

Every day, we rise to the challenge to make a difference and here’s how the role will make an impact:

• 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.

About Your Skills & Experience

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

• 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.
• Strong project management skills and the ability to deliver to time, cost and quality standards.
• Previous people management experience would be advantageous.
• TOPRA certification or RAC qualification preferred.