Regulatory Affairs Lead

Viatris Healthcare México S. de R.L. de C.V

Chez Viatris, nous envisageons la santé non pas telle qu'elle est mais telle qu'elle devrait être. Nous agissons avec courage et notre positionnement unique est source de stabilité dans un monde où les besoins en matière de santé sont en constante évolution. Viatris permet à chacun dans le monde entier de vivre en meilleure santé à chaque étape de sa vie. Via trois axes majeurs :

Accès : En fournissant des médicaments de haute qualité et reconnus, quels que soient le lieu de résidence ou la situation de chaque patient.

Leadership : En favorisant l’évolution de nos activités de façon durable et le développement de solutions innovantes pour améliorer la santé des patients.

Partenariat : En valorisant notre expertise collective afin de donner accès à tous à nos produits et services.

Every day, we rise to the challenge to make a difference and here’s how the Lead of Regulatory Affairs Mexico role will make an impact :

Lead of Regulatory Affairs Mexico will provide leadership and strategic direction of Viatris portfolio in the country.

To interface with other function leads (e.g., Commercial, Quality, Medical, Supply) to ensure collaborative connectivity with these key stakeholders, to support country and regional business objectives, as well as ensure product access.

Establish, and maintain, strong relationship with the local regulatory authorities.

Strong participation on Local Trade Associations, fostering critical discussions related to regulatory process improvement, aiming the environment shaping, as well as advocacy activities within country / region.

Key responsibilities for this role include :

Lead and manage the RA team in the development of regulatory strategies to support the registration of new products, generics, line extensions, major variations, and lifecycle management. Ensure that RA teams provide strategic regulatory input into our global regulatory strategies, thus providing optimal support for meeting local business objectives.

Maintain licenses (e.g. Marketing Authorizations) in compliance with local regulations by ensuring that corporate regulatory processes, SOP’s and systems are in place, and that the RA staff is properly trained in related systems and procedures.

Oversee and manage the completion of regulatory submissions and approvals under RA responsibility, according to defined strategies and launching plans.

Responsible for ensuring that all regulatory activities under RA responsibility, are compliant with local regulations, requirements, and practices.

Provide input to the relevant stakeholders related to new registrations and variations submissions, in-line with business objectives, ensuring strategies are adequately reflected in relevant country plans (e.g., business development or manufacturing supply) and alignment is achieved between regulatory activities and relevant country business / commercial plans.

Responsible for the development, leadership, and performance management of the direct reports team to achieve company objectives. Develop and enhance the capabilities and capacities of the RA teams through the identification and implementation of training and development needs.

Develop strong partnerships with in-country teams to facilitate the development and implementation of registration strategies to expedite new registrations, line extensions and life-cycle optimization.

Responsible for developing and supporting relationships with key external agencies. Support the Health Authority interface throughout the development and lifecycle of a product. Support long-term and positive relationship characterized by integrity, quality, compliance, and leadership. Facilitate meetings and participate in negotiations with regulatory authority, as necessary.

Active participation in Trade Associations and effective communication to key stakeholders of critical issues that could impact regulatory strategies or the business. Develop trends in the local regulatory environment and provide assessment of the impact to key stakeholders. Leverage regulatory intelligence / landscape knowledge to support the development and implementation of regulatory and business.

Experience required :

Scientific degree (preferably a pharmacist). A higher degree (MS or PhD) desirable.

Regulatory Affairs experience - minimum 10 years.

Proven ability to consistently deliver to time, cost, and quality standards.

Fluent in English – written and spoken communication skills.

Demonstrable experience across the commercialization lifecycle, with proven examples of contribution.

Proven ability to manage complex regulatory issues.

Local regulatory experience including knowledge of New Drug and Generic submission processes and product life cycle management activities. Regional regulatory experience would be an advantage.

General management experience and previous line management and leadership experience at senior local management level is essential.

Chez Viatris, nous proposons des salaires compétitifs, des bénéfices et un environnement inclusif au sein duquel vous pouvez mettre à profit votre expérience, vos perspectives et vos compétences pour aider à avoir un impact positif sur la vie des autres.

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