Manager, Global CMC

At Elanco (NYSE: ELAN) – it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.

At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment.

We believe that diversity is the driving force behind innovation, creativity, and overall business success.

Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals’ lives better makes life better – join our team today!

Your role:

The purpose of the Manager - CMC Regulatory is to work cross-functionally with Elanco R&D groups, manufacturing, and quality to develop global regulatory strategies, oversee submission preparation, and meet reporting requirements for the Authorization and Maintenance of registrations for new animal drugs with global regulatory agencies.

The role executes CMC regulatory functions necessary to support renewals and annual reporting requirements for approved veterinary drug products, including biocides, pesticides, and sterile injectables.

The candidate must possess strong knowledge of FDA(CVM), EPA, USDA(CVB), and EMA regulations, alongside ICH/VICH guidelines governing the authorization and post-approval compliance of Veterinary Medicinal Products.

Your Responsibilities:


* Life Cycle Management (LCM): Proven track record of overseeing end-to-end LCM of diverse pharmaceutical dosage forms, including otic solutions/suspensions, spot-on/pour-on solutions, collars, bee-hive strips, sterile injectables, and products derived from biotechnology/fermentation processes.


* Regulatory Strategy: Design and develop CMC regulatory strategies for the geo-expansion of marketed products, focusing on innovation and maximizing business benefit while maintaining regulatory compliance.


* Collaboration: Maintain positive partnerships with internal R&D, Quality, and Manufacturing groups, as well as global regulatory business partners.


* Submission Leadership: Lead CMC pre-submission preparation and proactively communicate strategies and critical issues to interdisciplinary project teams.


* Documentation & Compliance: Author high-quality CMC documentation for submissions and ensure all content, quality, and timelines are tracked according to functional procedures.


* Knowledge Management: Keep knowledge up to date regarding global regulatory guidelines and new technical trends.


* Mentorship: Provide training and mentorship to CMC team members as necessary.

Core Competencies


* Regulatory Expertise: Strong knowledge of FDA(CVM), EPA, USDA(CVB), EMA, and ICH/VICH g...