Director, Global CMC Strategy - Eye Care

23 hours ago

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Viatris

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

10,000+

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