Director Regulatory Affairs Global CMC

Benefits

Additional Information

McDermott Laboratories Limited At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access - Providing high quality trusted medicines regardless of geography or circumstance; Leadership - Advancing sustainable operations and innovative solutions to improve patient health; and Partnership - Leveraging our collective expertise to connect people to products and services. 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, Regulatory Affairs CMC, is an emerging senior level position, recognized as an expert for global CMC regulatory knowledge and quality expertise. The position is primarily devoted to the independent development of strategic CMC regulatory approaches to expedite the preparation and review of regulatory submissions in support of the L-Upjohn product portfolio. Every day, we rise to the challenge to make a difference and here's how the Director, Regulatory Affairs Global CMC role will make an impact: Cultivates sustainable & effective relationships across a network of stakeholders, partners and customers to drive and establish aligned approaches to regulatory strategies and/or policies. Interprets CMC regulatory requirements, develops strategies (including novel approaches), assesses risks and develops contingency proposals. Uses technical and scientific knowledge in the preparation and analysis of global CMC submission documentation and maintenance of product compliance and management of CMC change control. Ensures all CMC regulatory activities are executed effectively & efficiently, and in compliance with external regulatory requirements & internal quality procedures. Serves as a liaison with regulatory agencies for specific topics and providing oversight for the fulfillment of agency commitments and providing responses to agency queries. 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. Manages, leads and contributes significantly to Upjohn projects and initiatives within cross-functional project teams. Executes training related activities (e.g. compliance-related, HR policies) & individual development plans, participates in cross-disciplinary forums and learning opportunities, engages in Straight Talk & Listen exchanges, demonstrates and models adherence to all Viatris' behaviors & values, embraces & complies with Principles of Integrity. Participates, as required, in pharmaceutical industry conferences or serves externally as a representative to pharmaceutical trade group advisory committees relevant to CMC functions. Manages CMC responses in response to MedInfo queries Serves on governance & steering committees and may serve as the global CMC lead in Due Diligence exercises Serving as a People Manager: Provides guidance & direction to direct reports, managing resources, resource capacity & budget along with prioritizing workload appropriately. Accomplishes performance-management & training related activities, encourages & supports a healthy work/life balance, supports roll-out of HR policies, takes hiring-related decisions, participates in succession planning, provides guidance & facilitates opportunities for talent development, encourages colleague participation in cross-disciplinary forums & learning opportunities, engages colleagues in Straight Talk & Listen exchanges, demonstrates & models adherence to all Viatris' behaviors & values, embraces & complies with Principles of Integrity. Serves as the primary reviewer of global CMC strategic plans and documentation/submissions About Your Skills & Experience For this role, we're looking for a candidate who has an effective combination of the following qualifications, skills and experiences: Extensive years of mandatory hands-on CMC authoring experience (initial registrations or post-approval variations) Extensive years of people and/or project management experience, serving as a leader of matrixed & technical teams High level of knowledge of development &