Manager Regulatory CMC Sciences (Injectables)

Company Overview

Viatris is a global healthcare organization bridging generics and branded medicines to better meet worldwide healthcare needs. The firm produces high-quality medicines reaching nearly one billion patients globally each year, supporting health through every life stage and condition. Viatris is committed to fostering healthier communities via education, outreach, and expanded treatment access.

The company cultivates a collaborative, courageous culture enabling employees to realize their potential and make a meaningful impact on global health.

Role Summary

As Manager Regulatory CMC Sciences for Injectables, your key focus will be to devise and execute global regulatory strategies for injectable products, guiding CMC activities to achieve regulatory compliance and effective submissions.

Key Responsibilities

• Design and implement international CMC regulatory strategies for injectable medicines.
• Interpret regulatory demands and offer risk-based advice to internal teams.
• Prepare, review, and assess global CMC documentation and manage lifecycle changes.
• Support manufacturing sites with regulatory documentation and variation submissions.
• Ensure all CMC processes comply with pertinent regulations and control changes effectively.
• Collaborate with regional regulatory affairs, labelling, quality control, supply chain, and manufacturing groups to assist with submissions and agency engagements.
• Respond to health authority inquiries; participate in meetings and inspections as necessary.
• Serve as a regulatory knowledge expert within cross-functional teams on projects.
• Mentor colleagues, facilitate knowledge sharing, and build team capabilities.
• Stay informed on evolving regulatory requirements and industry developments; communicate impacts to stakeholders.

Required Qualifications and Experience

• Bachelor’s degree or equivalent in a scientific discipline.
• Regulatory Affairs experience within the pharmaceutical sector.
• Hands-on expertise in authoring post-approval CMC lifecycle submissions.
• Specific regulatory CMC background supporting injectable products.
• Strong understanding of global regulatory frameworks, especially U.S. regulations.
• Experience with submissions relating to injectables, parenteral, or combination products.
• Exceptional communication skills for regulatory documentation preparation and review.
• Thorough knowledge of cGMP, CFR, USP, European Pharmacopoeia, and FDA guidance.
• Proven track record collaborating across departments including Regulatory Affairs, Manufacturing, Supply Chain, Quality, Commercial, Medical, and Legal.
• Proficiency in Microsoft Office and regulatory systems such as TrackWise and Documentum.
• Strong project management abilities to meet time, quality, and cost targets.
• Previous people leadership experience is advantageous.
• Preferred certifications include TOPRA or Regulatory Affairs Certification (RAC).

Additional Information

Viatris is committed to building an equitable and inclusive workplace and encourages candidates with diverse backgrounds to apply, even if all criteria are not met. Benefits include career advancement, work-life balance programs, bonus schemes, health insurance, and pension plans.

Viatris values diversity and sustainability as core to its mission, advancing responsible operations to improve global health.

Location and Work Arrangement

This full-time role is based onsite in Aille, County Galway, Ireland.