Director Regulatory CMC Sciences Project Management

Requirements

• Uses technical and scientific knowledge in support of submission preparation and review, and assures regulatory compliance through the appropriate use of Change Control, external and internal regulatory requirements, and maintenance of Viatris’ regulatory systems.
• Presents and articulates issues for resolution, communicating regularly with key stakeholders to ensure alignment, providing consultation as a scientific/technical resource within the department/cross-functional and therapeutic teams for assigned projects, mentoring and sharing experience with colleagues.
• experience (initial registrations or post-approval variations) – generalist knowledge across global regulatory affairs disciplines.
• Extensive knowledge of post-approval variations specific to site transfers and alternate API sourcing, and of cGMP’s to assess technical, scientific & regulatory merits of regulatory information, commitments and data to lead teams and/or complex projects.
• Extensive technical, functional, and industry knowledge in shaping project strategy, reducing regulatory burden & improving regulatory flexibility across global markets and diverse therapeutic areas.
• Advanced understanding of current and emerging regulatory
• Possesses sound understanding of business expectations, with proven ability to partner successfully with GRA leadership and other senior stakeholders in achieving objectives.
• Skills & Abilities: Advanced skills in written & oral communications (mandatory).
• Computer literacy with Microsoft Office Suite and Documentum-based applications. Prior
• experience managing projects and matrixed teams and/or serving as a people manager Advanced knowledge of global regulatory
• Ability to engage in the external regulatory and pharmaceutical environment.
• Proven ability to deliver to time, cost and quality standards Demonstrated strategic thinking and ability to integrate strategies into actionable plans Demonstrated
• experience serving as a Subject Matter Expert in specific relevant disciplines or as a recognized resource for specific pharmaceutical science projects and/or specialized expert in specific regulatory domains At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past

Benefits