Regulatory Affairs Manager CMC

Company Overview

Viatris, represented by McDermott Laboratories Limited in Dublin, is a global healthcare organization that bridges the gap between generic and branded medicines, providing high-quality products to nearly 1 billion patients worldwide annually. Our portfolio spans iconic brand-name products, generics, complex generics, and therapies across multiple therapeutic areas. We are dedicated to improving global health through education, outreach, and enhanced access to treatments while fostering a resilient and collaborative work culture.

Role Summary

The Regulatory Affairs Manager CMC is responsible for independently preparing regulatory evaluations and contributing to the global regulatory strategies throughout drug development and manufacturing lifecycles, specifically supporting the Upjohn product portfolio. This role ensures compliance, manages regulatory submissions, and supports the lifecycle management of products.

Key Responsibilities

• Ensure adherence to regulatory standards and internal quality procedures globally.
• Develop and implement comprehensive regulatory strategies to minimize risks.
• Prepare and oversee high-quality Chemistry, Manufacturing and Controls (CMC) regulatory submissions and management plans for international regulatory agencies.
• Represent CMC on cross-functional project teams, evaluate regulatory risks, and influence global regulatory strategies aligned with scientific and technical parameters.
• Manage regulatory challenges, monitor regulatory commitments, and maintain timelines across multiple projects and markets with minimal supervision.
• Author and coordinate CMC activities relating to new product registrations, post-approval changes, renewals, annual reports, line extensions, and response to agency inquiries.
• Provide technical and scientific advice on complex projects and mentor team members within the specialty.
• Build and nurture effective collaborations with local and global partners in Research & Development, Quality, and Regulatory functions.

Candidate Profile

• Bachelor’s degree or equivalent is required; Master’s degree preferred; equivalent combinations of education and experience will be considered.
• Substantial pharmaceutical industry experience encompassing Quality, Technical Services, or Research & Development, with significant pharmaceutical regulatory experience.
• Practical experience in authoring CMC documents for initial registrations or post-approval variations.
• Strong understanding of pharmaceutical development, commercial processes, and current Good Manufacturing Practices (cGMP) to assess scientific, technical, and regulatory aspects of CMC information.
• Excellent verbal and written communication capabilities.
• Prior experience managing projects and proficiency with Microsoft Office Suite and Documentum-based platforms.
• Ability to operate independently, managing complex and non-standard problems with minimal oversight.

Company Culture and Inclusion

Viatris values diversity, inclusion, and authenticity in the workplace, encouraging candidates who may not meet every requirement but are motivated to apply. The company fosters a culture where diverse experiences and perspectives help redefine healthcare.

Benefits

• Opportunities for career growth and progression.
• Programs promoting work-life balance.
• Eligibility for bonus schemes.
• Comprehensive health insurance plans.
• Pension contributions.

Diversity & Inclusion

Diversity and inclusion are integral to Viatris’ mission, embracing diverse talents as key strengths to transform healthcare positively.

Sustainability Commitment

Viatris is committed to corporate social responsibility and sustainable practices, aiming to empower healthier living at all life stages while considering community impacts.

Equal Opportunity

Viatris is an Equal Opportunity Employer committed to fair treatment and access to employment opportunities.