Director, Global CMC Strategy - Eye Care

December 4, 2024

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Viatris

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Viatris is a global healthcare company committed to improving access to high-quality medicines for patients worldwide. They offer a diverse range of products including brands and generics, and focus on various therapeutic areas that address both noncommunicable and infectious diseases. Viatris operates with a goal of providing reliable medication supply, ensuring that patients receive the treatments they need when and where they need them. The company is dedicated to healthcare empowerment, facilitating healthier living through various stages of life, supported by their global healthcare gateway. Their operations are grounded in a strong commitment to sustainability, corporate governance, and regulatory compliance across different geographies.

Pharmaceuticals • Generics • Anesthesia & Pain Management • CNS • Cardiovascular

10,000+ employees

Founded 2020

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Guide, develop and execute regional and global regulatory CMC strategies • Facilitate timely regulatory submission and approval • Manage adherence to the Regulatory Affairs schedule • Provide strategic recommendations and direction • Communicate proposed risks and risk mitigation strategies • Cultivate effective relationships across a network of stakeholders • Ensure required documentation is prepared to a high standard • Author CMC sections of dossiers • Ensure lifecycle management activities are assessed and executed effectively • Organize, lead or participate in meetings with regulatory agencies • Ensure quality expectations are met for all submissions • Work closely with other Regulatory team members • Influence the evolving regulatory environment through engagement

🎯 Requirements

• 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) • A minimum of 6 years pharmaceutical regulatory experience required • Ability to read and interpret comprehensive and intricate research 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 that require independent judgment and analysis • Ability to draw inferences and use deductive reasoning with no prescribed procedures to solve complex problems • Global Regulatory Affairs CMC strategy, with hand-on CMC authoring experience - Minimum of 5+ years • High level of knowledge of development & commercial activities and cGMP’s • Extensive technical, functional, and industry knowledge in shaping project strategy • Independently capable of executing activities related to complex projects across all aspects of drug development and commercial manufacturing product lifecycle • Knowledge of eyecare products and product development an advantage • Advanced understanding of current and emerging regulatory requirements & expectations • Proven ability to partner successfully with other Regulatory functions, Manufacturing & Supply Chain, Quality, Safety, Medical, Commercial, Legal and senior stakeholders • Advanced skills in written & oral communications (mandatory) • Computer literacy with Microsoft Office Suite and Documentum-based applications • Prior experience (minimum of 5+ years) managing projects and matrixed teams and/or serving as a people manager • Proven ability to deliver to time, cost and quality standards • Demonstrated strategic thinking and ability to integrate strategies into actionable plans

🏖️ Benefits

• Competitive salaries • Benefits • Inclusive environment