Head of Global Regulatory CMC Sciences - (Based Anywhere in Europe)

Head of Global Regulatory CMC Sciences - (Based Anywhere in Europe) page is loaded Head of Global Regulatory CMC Sciences - (Based Anywhere in Europe)locations: Northern Cross, Dublin, Ireland: Hatfield, England, United Kingdomtime type: Praca na pełny etatposted on: Opublikowano dzisiajjob requisition id: RMcDermott Laboratories LimitedW Viatris postrzegamy opiekę zdrowotną taką, jaką być powinna, a nie taką jaka jest. Działamy odważnie i mamy wyjątkowe uwarunkowania, dzięki czemu stanowimy źródło stabilności w świecie zmieniających się potrzeb zdrowotnych. Viatris umożliwia ludziom na całym świecie zdrowsze życie na każdym jego etapie Osiągamy to poprzez (via): Dostęp - dostarczanie pacjentom wysokiej jakości leków, cieszących się powszechnym zaufaniem, w czasie i miejscu, w jakim ich potrzebują; Przywództwo - podejmowanie zrównoważonych działań i opracowywanie innowacyjnych rozwiązań w celu poprawy zdrowia pacjentów; oraz Partnerstwo - wykorzystanie wspólnej wiedzy w celu dostarczenia naszych produktów i usług.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 Head of Global Regulatory CMC is a senior level position, recognized as an expert for global CMC regulatory knowledge, quality expertise and assuring excellence in execution of a large team of CMC professionals. The position is devoted to the leadership of team leaders having responsibility for the development of strategic CMC regulatory approaches to expedite the preparation and review of global regulatory CMC submissions in support of the Viatris branded products, across their clinical and commercial lifecycles. The incumbent plays a key role in developing and communicating strategic vision, assuring regulatory compliance, setting priorities, and working with internal and external partners to influence business decisions and priorities. The role demands clear leadership with excellent communication and stakeholder managementEvery day, we rise to the challenge to make a difference and here's how the Head of Global Regulatory CMC Sciences role will make an impact.Key responsibilities for this role include: Provides leadership and strategic direction to the Viatris Global Regulatory CMC team, for all branded product formulations/presentations, second brands and authorized generics. Establishes and implements strong partnerships with Global, Regional, and Local stakeholders from cross-functional disciplines (e.g. R&D, Quality, Technical Services, Operations, Commercial & Medical) to foster the development and implementation of CMC registration strategies which expedite the registration of new products, line extensions, and post-approval and life-cycle maintenance changes via risk identification and mitigation. Provides input into new business development opportunities. Assures coordination and implementation of consistent standards and process throughout the Global CMC regulatory teams, and establishes alignment with regulatory processes/principles, global policies & regulations, and corporate leadership priorities and values. Establishes team objectives and operational/strategic plans that are aligned to the strategic direction and vision of the Global Regulatory Affairs team and those of other key stakeholders (R&D, Operations, Commercial and Medical). Supports the development and maintenance of excellent relationships with global regulatory agencies to influence future CMC regulations and to problem solve specific project/compound/product issues. Supports Regulatory Affairs partners in the development and maintenance of local regulatory agency relationships. Partners with corporate affairs, government affairs, and other local policy leaders to achieve business policy objectives. Establishes/defines the roles and required competencies of the Global CMC team and implements strategies to enhance capacity and capabilities. Directs/provides opportunities including training/rotational development, professional growth and development of the global CMC team. Provides oversight and direction respecting performance management, talent acquisition, and succession planning. Collaborates with the Regulatory Policy and Intelligence team and Country/Regional Strategists to ensure that processes are in place to monitor and positively influence the global/local/regional CMC regulatory environment. Establishes procedure and processes to ensure that knowledge gained through this process is captured (e.g. best practices, requirements databases, etc.) and incorporated into ongoing and future regulatory strategies. Works with regulatory colleagues across business verticals/functions to develop and strengthen relationships, harmonize practices and deliver a single One-Viatris voice. Collaborates with Global, Regional and Local Regulatory, R&D, Technical Services, Clinical Development/Medical Affairs and Commercial to develop HA and KOL interaction strategies that are in alignment with filing strategies. Fosters and increases engagement with Global Health Authorities. Contribute to CMC change management and continuous improvement projects. Closing date for applications is 2nd January 2026 About Your Skills & Experience A higher degree (MS, PhD, PharmD, MBA) is preferred. Extensive global CMC leadership experience is required along with deep technical and business experience in a relevant R&D technical field. Demonstrable CMC experience across the drug development and commercial lifecycle, with proven examples of contribution. Experience across the product development lifecycle for products in key geographies, including success in a leadership position for enabling complex and/or innovative product approvals. Experience in early product development including BD partnerships and diligence assessments. Experience with branded products and generic drug regulatory submissions and approvals, drug master files (DMFs), Certificate of Suitability (CEP) filings, and contribution to the development of global compendial requirements. Experience with diverse dosage forms, including sterile products and medical devices, is desirable. Global regulatory experience including thorough knowledge of CMC aspects of clinical trials, commercial submission processes and product life cycle management activities. Line management and leadership experience at a senior management level is essential. Demonstrable experience of effective delivery in a complex matrix environment. Knowledge of global policies, regulations and guidelines, with extensive technical, functional and industry knowledge in shaping project strategies, reducing regulatory burden and improving regulatory flexibility across global markets and diverse therapeutic areas. 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. Strong understanding of pharmaceutical development and impact on global business