Director Respiratory Regulatory CMC

Benefits

Additional Information

Mylan Pharma UK 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 Every day, we rise to the challenge to make a difference and here's how the Director Respiratory Regulatory 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. 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. Guides preparation of CMC submission documentation where assigned 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. Responsibilities include the lead in preparations and interactions for regulatory authority meetings Manages, leads and contributes significantly to the respiratory portfolio, individual projects and initiatives within cross-functional project teams. Participates, as required, in pharmaceutical industry conferences or serves externally as a representative to pharmaceutical trade group advisory committees relevant to CMC functions. Monitor the external competitor and regulatory environment and build knowledge into project strategies. Performs other duties or equivalent duties for other product types as assigned Serves as the primary reviewer of global CMC strategic plans and documentation/submissions for the assigned products (primarily within the respiratory product portfolio) 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: Mandatory hands-on CMC authoring experience (initial registrations or post-approval variations) Mandatory hands-on experience in Regulatory CMC for respiratory/inhaled products High level of knowledge of development & commercial activities and cGMP's to assess technical, scientific & regulatory merits of CMC information, commitments and data to lead teams and/or complex projects. Specific knowledge in development and life cycle management of respiratory/inhaled products is highly preferred 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 all aspects of drug development and commercial manufacturing product lifecycle. Specific knowledge in development of respiratory/inhaled products or other combination product types with similar complexity is highly preferred Advanced understanding of current and emerging regulatory requirements & expectations, criteria for submission & approval globally, & experience in leading negotiations and interactions with regulatory authorities for projects and/or policy initiatives. Possesses sound understanding of business expectations across partner lines, with proven ability to partner successfully with other Regulatory functions, Manufacturing & Supply Chain, Quality, Safety, Medical, Commercial, Legal and senior stakeholders to achieve objectives. 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 Ability to participate in interactions with regulatory authorities to respond to requests either directly or in conjunction with Regulatory Affairs personnel. Demonstrated commitment & dedication to scientific & regulatory integrity & quality compliance. Ability to engage i