Manager, Brands Regulatory CMC Sciences

About Viatris

Viatris is a global healthcare company bridging the gap between generics and branded pharmaceuticals, offering a wide portfolio that includes iconic brand-name products, generics, and specialty medicines. We serve approximately one billion patients worldwide each year, addressing health needs from birth through chronic and acute disease stages. Our commitment extends to creating healthier communities globally through education, outreach, and expanded access to treatments.

We foster a collaborative and courageous workplace culture that empowers employees to realize their full potential and make a meaningful impact globally.

Role Overview

The Manager, Brands Regulatory CMC Sciences, will be responsible for leading the local medical team, aligning and executing medical strategies at local and regional levels, collaborating across functions, and influencing healthcare stakeholders to drive significant patient and business outcomes.

Key Responsibilities

• Ensure compliance with regulatory standards globally and maintain consistency with external regulatory requirements and internal quality systems.
• Apply regulatory expertise and sound judgment to manage regulatory strategy development, submission quality, policy reviews, and investigations.
• Develop comprehensive regulatory strategies to minimize risks by integrating technical and regulatory expertise.
• Prepare and manage high-quality Chemistry, Manufacturing, and Controls (CMC) regulatory submissions and strategize submission plans for global agencies.
• Execute product portfolio delivery adhering to regulatory policies and operational procedures.
• Act as the CMC representative on core projects, managing project activities, assessing regulatory risks, and crafting global regulatory strategies aligned with scientific and technical standards.
• Manage regulatory concerns and maintain accurate submission records, tracking commitments and timelines for projects with minimal oversight.
• Communicate effectively with stakeholders to resolve issues and provide expert consultation on assigned projects; mentor colleagues and share regulatory knowledge.
• Author and coordinate activities for new registrations, post-approval variations, renewals, annual reports, and line extensions, ensuring all filings meet regulatory standards.
• Lead responses to agency queries and conduct quality reviews of regulatory submissions.
• Serve as a subject matter expert providing technical and scientific guidance for complex projects.
• Prioritize and independently manage assigned workloads effectively.
• Develop collaborative relationships with internal partners including R&D, Quality, and various regulatory teams across global, country, and regional levels.
• Participate in training, development programs, and promote adherence to company values and integrity principles.
• Contribute to CMC project initiatives and represent the company at relevant pharmaceutical industry conferences and advisory committees.
• Mentor colleagues and support their professional growth within the CMC regulatory domain.
• Perform additional duties as required.

Qualifications and Experience

The ideal candidate will have:

• At least 2 years of hands-on experience authoring CMC documentation for initial registrations or post-approval changes.
• Solid understanding of development, commercial activities, and cGMPs critical for assessing technical, scientific, and regulatory merits of CMC data and leading project teams.
• Industry knowledge to influence strategic direction, reduce regulatory burdens, and enhance flexibility to meet business needs.
• Comprehensive understanding of global and regional regulatory requirements, submission criteria, and experience interacting with regulatory authorities.
• Ability to interpret and apply updated global CMC guidelines and contribute to regulatory strategies proactively.
• Awareness of emerging scientific and manufacturing technologies.
• Sound understanding of business expectations and regulatory CMC principles, policies, and industry operating procedures.

Skills and Competencies

• Advanced written and oral communication capabilities.
• Proficiency with Microsoft Office and Documentum-based applications.
• Experience in project management and stakeholder engagement.
• Capability to interact with regulatory bodies independently or with Regulatory Affairs personnel.
• Commitment to scientific and regulatory integrity and compliance quality standards.
• Ability to act as a subject matter expert in pharmaceutical science and regulatory domains.

Diversity and Inclusion

Viatris values diversity and inclusion as a critical part of its mission to redefine healthcare. We encourage candidates with varied backgrounds to apply, even if they do not meet every single qualification, as we seek authentic talent passionate about making a difference.

Employment Benefits

We provide competitive salaries and benefits, fostering an inclusive environment where employees leverage their diverse experiences and skills to impact health worldwide. We also offer career advancement opportunities and work-life balance initiatives.

Equal Opportunity

Viatris is an Equal Opportunity Employer committed to building an inclusive and authentic workplace.