Director, Global Regulatory Lifecycle Management, Small Molecule (m/f/d)

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.

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.

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

Benefits and Perks:

• 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% 401(k) 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.

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