Director Global CMC Strategy – Based Anywhere in Europe
Apply locations Hatfield, England, United Kingdom Zug, Zug, Switzerland Northern Cross, Dublin, Ireland time type Full time posted on Posted 2 Days Ago job requisition id R5653293 Generics [U.K.] Ltd. 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; 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 Global CMC Strategy is an emerging senior level position, recognized as an expert for global CMC regulatory knowledge and quality expertise. The Director will be responsible for providing regulatory guidance and leadership for eyecare products, expediting the preparation and review of regulatory submissions in support of Viatris’ eyecare portfolio. Every day, we rise to the challenge to make a difference and here’s how the
Director Global CMC Strategy
role will make an impact: Guide, develop and execute regional and global regulatory CMC strategies specific to assigned Viatris’s eyecare portfolio to meet the needs within the regions. Facilitate timely regulatory submission and approval by managing adherence to the Regulatory Affairs schedule for new applications and deficiency responses. Provide strategic recommendations and direction to technical teams to reduce regulatory risks and minimize delays associated with submission and approval of products. Ensuring an aligned regulatory position is reached and communicate proposed risks and risk mitigation strategies to Senior Leadership. Cultivate sustainable and effective relationships across a network of stakeholders, partners and customers to drive and establish aligned approaches to regulatory strategies and/or policies. Direct activities to ensure the required documentation is prepared to a high standard and that all regulatory requirements and/or commitments are met for obtaining Marketing Authorizations. Author CMC sections of the dossiers from technical documentation, as applicable. Ensure lifecycle management and maintenance activities, including change controls, are assessed and executed effectively and efficiently. Develop and maintain constructive working relationships with Health Authority contacts. Organize, lead or participate in meetings with regulatory agencies, as appropriate. Ensure quality expectations are met for all submissions and Health Authority interactions. Work closely with other Regulatory team members to develop and ensure adherence to consistent and appropriate processes, systems, working practices, shared learnings and quality standards. Understand current global and regional evolving regulations and guidelines with the ability to assess the impact of these requirements to products/projects. Support regulatory Due Diligence activities for business development opportunities. Provide input to and adhere to departmental budget. Perform other duties as assigned. About Your Skills & Experience Minimum of a Bachelor's degree (or equivalent). A Master's degree (or equivalent) preferred. Extensive pharmaceutical experience with relevant technical experience (Quality, Technical Services, R&D) and pharmaceutical regulatory experience required. Prior experience managing projects and matrixed teams and/or serving as a people manager. Global Regulatory Affairs CMC strategy, with hands-on CMC authoring experience (initial registrations or post-approval variations). High level of knowledge of development & commercial activities and cGMP’s to assess technical, scientific & regulatory merits of CMC information, commitments and data. Extensive technical, functional, and industry knowledge in shaping project strategy, reducing regulatory burden & improving regulatory flexibility across global markets. Advanced understanding of current and emerging regulatory requirements & expectations, criteria for submission & approval globally. Proven ability to partner successfully with other Regulatory functions, Manufacturing & Supply Chain, Quality, Safety, Medical, Commercial, Legal and senior stakeholders. Ability to participate in interactions with regulatory authorities to respond to requests. Demonstrated strategic thinking and ability to integrate strategies into actionable plans. 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 experience doesn’t fully align with every requirement, we still encourage you to apply. Benefits at Viatris Excellent career progression opportunities Work-life balance initiatives Bonus scheme Health insurance Pension Diversity & Inclusion at Viatris At Viatris, diversity and inclusion are essential to our mission. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion Sustainability at Viatris Corporate social responsibility is fundamental to the Viatris mission. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility Viatris is an Equal Opportunity Employer.
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Apply locations Hatfield, England, United Kingdom Zug, Zug, Switzerland Northern Cross, Dublin, Ireland time type Full time posted on Posted 2 Days Ago job requisition id R5653293 Generics [U.K.] Ltd. 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; 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 Global CMC Strategy is an emerging senior level position, recognized as an expert for global CMC regulatory knowledge and quality expertise. The Director will be responsible for providing regulatory guidance and leadership for eyecare products, expediting the preparation and review of regulatory submissions in support of Viatris’ eyecare portfolio. Every day, we rise to the challenge to make a difference and here’s how the
Director Global CMC Strategy
role will make an impact: Guide, develop and execute regional and global regulatory CMC strategies specific to assigned Viatris’s eyecare portfolio to meet the needs within the regions. Facilitate timely regulatory submission and approval by managing adherence to the Regulatory Affairs schedule for new applications and deficiency responses. Provide strategic recommendations and direction to technical teams to reduce regulatory risks and minimize delays associated with submission and approval of products. Ensuring an aligned regulatory position is reached and communicate proposed risks and risk mitigation strategies to Senior Leadership. Cultivate sustainable and effective relationships across a network of stakeholders, partners and customers to drive and establish aligned approaches to regulatory strategies and/or policies. Direct activities to ensure the required documentation is prepared to a high standard and that all regulatory requirements and/or commitments are met for obtaining Marketing Authorizations. Author CMC sections of the dossiers from technical documentation, as applicable. Ensure lifecycle management and maintenance activities, including change controls, are assessed and executed effectively and efficiently. Develop and maintain constructive working relationships with Health Authority contacts. Organize, lead or participate in meetings with regulatory agencies, as appropriate. Ensure quality expectations are met for all submissions and Health Authority interactions. Work closely with other Regulatory team members to develop and ensure adherence to consistent and appropriate processes, systems, working practices, shared learnings and quality standards. Understand current global and regional evolving regulations and guidelines with the ability to assess the impact of these requirements to products/projects. Support regulatory Due Diligence activities for business development opportunities. Provide input to and adhere to departmental budget. Perform other duties as assigned. About Your Skills & Experience Minimum of a Bachelor's degree (or equivalent). A Master's degree (or equivalent) preferred. Extensive pharmaceutical experience with relevant technical experience (Quality, Technical Services, R&D) and pharmaceutical regulatory experience required. Prior experience managing projects and matrixed teams and/or serving as a people manager. Global Regulatory Affairs CMC strategy, with hands-on CMC authoring experience (initial registrations or post-approval variations). High level of knowledge of development & commercial activities and cGMP’s to assess technical, scientific & regulatory merits of CMC information, commitments and data. Extensive technical, functional, and industry knowledge in shaping project strategy, reducing regulatory burden & improving regulatory flexibility across global markets. Advanced understanding of current and emerging regulatory requirements & expectations, criteria for submission & approval globally. Proven ability to partner successfully with other Regulatory functions, Manufacturing & Supply Chain, Quality, Safety, Medical, Commercial, Legal and senior stakeholders. Ability to participate in interactions with regulatory authorities to respond to requests. Demonstrated strategic thinking and ability to integrate strategies into actionable plans. 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 experience doesn’t fully align with every requirement, we still encourage you to apply. Benefits at Viatris Excellent career progression opportunities Work-life balance initiatives Bonus scheme Health insurance Pension Diversity & Inclusion at Viatris At Viatris, diversity and inclusion are essential to our mission. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion Sustainability at Viatris Corporate social responsibility is fundamental to the Viatris mission. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility Viatris is an Equal Opportunity Employer.
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