Sr. Director, Global Regulatory Affairs – Pharmaceuticals

Position Description

Regulatory Strategy and Leadership

Lead the US Pharmaceuticals team in developing regulatory strategy for new animal drugs and lifecycle management of marketed animal drugs under CVM and EPA governance.

Submission Management

Guide submission preparation and ensure compliance with reporting requirements for approval processes.

Collaboration and Alignment

Engage with R&D, Regulatory, and Commercial leadership to align priorities and ensure coverage of all key activities.

Representation

Serve as the main point of contact with the CVM, representing Elanco on key AHI Working Groups.

Innovation Support

Directly support key US Innovation projects from early development through registration.

Team Management

Directly manage and develop a team, allocating resources effectively to support business needs.

Positive Work Environment

Foster a positive, creative, and psychologically safe work environment within the US Pharmaceuticals team and the broader Global Regulatory Affairs organization.

Functions, Duties, Task

1. Lead team in executing pharmaceutical and biocide regulatory submissions in the US.
2. Provide regulatory guidance to commercial business and R&D on US submission strategies for innovation products.
3. Manage submission planning and tracking of US regulatory procedures for innovation and lifecycle management products.
4. Prioritize submissions in collaboration with other functions, considering resource constraints.
5. Act as a point of contact for US regulatory authorities.
6. Lead team to participate in industry associations, influencing the adoption of best practices in animal health regulatory advocacy programs.
7. Develop talent for regional and global competitiveness, identifying leaders and providing mentoring opportunities.

Compliance and Qualifications

• Comply with all company policies, including Quality frameworks, Code of Conduct, anti-discrimination, harassment, and HSE policies.
• Minimum Qualification: Bachelor’s Degree with at least 10 years of relevant work experience in the Animal Health Industry.
• Experience with global regulatory agencies.
• Strong communication skills, both written and oral.
• Ability to make decisions in ambiguous situations.
• Previous management experience.
• Strong organizational skills.

Additional Preferences

• Direct experience negotiating with US Health Authorities.
• Language: Fluency in English (verbal and written).

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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