Director, Global CMC Strategy (Eye Care)

Role Summary

Director, Global CMC Strategy (Eye Care) role focusing on leading regulatory CMC strategies for Viatris Eye Care portfolio, guiding submissions, risk management, and cross-functional collaboration to ensure timely approvals and lifecycle maintenance.

Responsibilities

• To guide, develop and execute regional and global regulatory CMC strategies specific to assigned Viatris‚Äô 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. Ensure 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.
• Ensures lifecycle management and maintenance activities, including change controls, are assessed and executed effectively and efficiently.
• Developing and maintaining 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.
• Understanding of current global and regional evolving regulations and guidelines with the ability to assess the impact of these requirements to products/projects. Influence the evolving regulatory environment through Health Authority engagement, partners and trade associations.
• Supporting regulatory Due Diligence activities for business development opportunities.
• Provide input to and adhere to departmental budget.

Qualifications

• Minimum of a Bachelor's degree (or equivalent). A Master's degree (or equivalent) preferred. A minimum of 8-12 years pharmaceutical experience with relevant technical experience (Quality, Technical Services, R&D) and a minimum of 6 years pharmaceutical regulatory experience required. Combination of experience and/or education considered.
• Ability to read and interpret complex documents. Ability to write scientific reports and technical correspondence. Ability to work with executives and communicate abstract concepts. Ability to present to a high level of the organization and groups outside of the organization.
• Ability to solve problems with complex variables through non-standardized solutions requiring independent judgment and analysis. Ability to draw inferences and use deductive reasoning with no prescribed procedures.
• Global Regulatory Affairs CMC strategy, with hands-on CMC authoring experience (initial registrations or post-approval variations) - Minimum 5+ years
• High level of knowledge of development & commercial activities and cGMPs to assess technical, scientific & regulatory merits of CMC information, commitments and data to lead teams and/or complex projects.
• Extensive technical, functional, and industry knowledge in shaping project strategy, reducing regulatory burden & improving regulatory flexibility across global markets. Experience across diverse therapeutic areas; eyecare knowledge is an advantage.
• Advanced understanding of current and emerging regulatory requirements & expectations, criteria for submission & approval globally, and experience in leading negotiations with regulatory authorities.
• Strong collaboration skills with Regulatory, Manufacturing & Supply Chain, Quality, Safety, Medical, Commercial, Legal and senior stakeholders.
• Advanced written & oral communications skills.
• Proficiency in Microsoft Office and Documentum-based applications.
• Prior experience (minimum 5+ years) managing projects and matrixed teams and/or as a people manager.
• Ability to engage with regulatory authorities to respond to requests.
• Commitment to scientific and regulatory integrity and quality compliance.
• Ability to participate in external regulatory and pharmaceutical environment.
• Proven ability to deliver on time, cost and quality standards.
• Demonstrated strategic thinking and ability to translate strategies into actionable plans.
• Ability to function autonomously with minimal supervision.
• Typically sedentary with potential for standing/walking; physical demands may include light lifting up to 10 lbs. Periodic travel may be required.
• English proficiency (speaking, comprehension, reading, writing) required.

Education

• None beyond those listed in Qualifications (Bachelor's required; Master's preferred).