Regulatory Affairs Lead

Viatris • Mexico, ME

1d

About The Position

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. 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.

Requirements

• Scientific degree (preferably a pharmacist).
• 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.
• General management experience and previous line management and leadership experience at senior local management level is essential.

Nice To Haves

• A higher degree (MS or PhD) desirable.
• Regional regulatory experience would be an advantage.

Responsibilities

• 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.

Benefits

• At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level