Director Regulatory CMC Sciences Project Management

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McDermott Laboratories Limited Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. We have been included on number of award lists that demonstrate the impact we are making. Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment. For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world. The Role & What You Will Be Doing The Director Reg. CMC Sciences Project Management is an emerging senior level position, recognized as a regulatory expert in the management of global and complex post-approval changes. The position is primarily devoted to the project management of large-scale and complex manufacturing site transfers and alternate API sourcing activities, impacting Viatris internal sites and CMOs largely across the core, complex and established brands product portfolios. The Role & What You Will Be Doing Every day, we rise to the challenge to make a difference and here's how the Director Regulatory CMC Sciences Project Management role will make an impact: For this role, we're looking for a candidate who has an effective combination of the following qualifications, skills and experiences: Provides regulatory project management support for global, large-scale and complex network optimization projects Serves as a matrixed manager to coordinate and align on priorities across multiple projects, developing and maintaining tools for submission planning, tracking and forecasting best/base approval timing to enable accuracy for supply continuity planning to minimize stock-outs. Provides team leader oversight for all contracted GRA resources Cultivates sustainable and effective relationships across multiple internal stakeholders (e.g., Ops, R&D, Quality, Sourcing) to drive global regulatory assessments for site transfers and alternate sourcing activities, predicated on robust gap assessments and regulatory strategies, and right-first-time submission packages. Assesses and communicates regulatory risks, and develops and tracks progress of mitigation plans. 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. Develops dashboards and metrics for reporting to stakeholders. Position is expected to serve as the single Point of Contact internally across a large portfolio of projects, and manage up to 20+ ETW resources across a matrixed and global organization. About Your Skills & Experience Knowledge: Mandatory hands-on CMC authoring experience (initial registrations or post-approval variations) - generalist knowledge across global regulatory affairs disciplines. Proven capability in managing complex Regulatory projects and use of project management tools. 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. Independently capable of executing activities related to complex projects across the commercial manufacturing product lifecycle. Advanced understanding of current and emerging regulatory requirements & expectations, criteria for submission & approval globally. Possesses sound understanding of business expectations, with proven ability to partner successfully with GRA leadership and other senior stakeholders in achieving objectives. Skills & Abi

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