Director, Global Regulatory Lifecycle Management, Small Molecule

Education : EQUIVALENTEXPERIENCE

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: Director, Global CMC Regulatory Affairs – Biocides/Pesticides, Topicals and Collars

As the Director, you will guide a dedicated team responsible for the global regulatory management of our Biocides, Pesticides, Topicals, and Collar products. You'll be instrumental in developing regulatory strategies, overseeing submission preparation, and ensuring compliance with global regulatory agencies (including FDA, EMA, EPA, and ECHA) for the maintenance and innovation of these specialized animal health categories.

Your Responsibilities:

• Guide, manage, and develop a high-performing global CMC group, ensuring effective resource allocation, performance management, and talent development.
• Provide expert CMC Regulatory advice on submission strategy and tactics for innovation and lifecycle submissions, specifically for complex formulations and delivery systems.
• Represent regulatory CMC expertise on global development teams and governance meetings, providing critical insights on regulatory risk/benefit evaluations.
• Partner with global stakeholders across Elanco, including Technical Development, Global Marketing, Manufacturing, and Quality, to motivate departmental strategy and efficiency.
• Manage the timely submission of post-approval CMC documentation and guide interactions with global regulatory authorities (e.g., FDA-CVM, EMA, EPA) on CMC technical sections.

What You Need to Succeed (minimum qualifications):

• Education: Bachelor's Degree in a physical, chemical, or life sciences discipline.
• Experience: A minimum of 10 years of pharmaceutical or chemical regulatory experience, with at least 5 years in the preparation and submission of CMC filings for global markets.
• Skills: Demonstrated leadership ability with experience developing teams, and in-depth knowledge of global regulatory CMC requirements.

What will give you a competitive edge (preferred qualifications):

• Experience with complex dosage forms such as topicals, medicated collars, or polymer-based delivery systems.
• Experience navigating the interface between veterinary medicine and pesticide/biocide regulations (e.g., EPA/FDA or ECHA/EMA).
• Advanced degree (MS, PhD, or PharmD).
• Knowledge and understanding of Quality by Design (QbD), Quality by Regulation (QbR), and Good Manufacturing Practices (GMP).
• Proven ability to influence internal and external stakeholders, including direct interaction with regulatory agencies.

Additional Information:

• Travel: 10-15%
• Location: Indianapolis (USA), Hook (UK), or Monheim (Germany) - On-Site Work Environment

Don't meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!

Elanco Benefits and Perks:

We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:

• Multiple relocation packages
• Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
• 8-week parental leave
• 9 Employee Resource Groups
• Annual bonus offering
• Flexible work arrangements
• Up to 6% 401K matching

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.