Job Description

As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals\' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco\'s promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.

Position Description:

The purpose of the Regulatory Consultant, CMC Regulatory Affairs, position is to provide Regulatory support for Elanco\xe2\x80\x99s Marketed Product portfolio (Supplements/Variations, Renewals and Annual Reports, as applicable). The Regulatory Consultant will:

• Work cross-functionally with Elanco manufacturing and quality to develop regulatory strategy, oversee submission preparation in order to meet reporting requirements.
• Participate in interactions with regulatory authorities, obtaining alignment on project/product strategy.
• Manage activities associated with the US Annual Reporting requirements.
• Facilitate geo-expansion activities.
• Participate in special projects, as assigned, aimed at driving organizational improvements and efficiency.
• Act as a technical mentor for junior CMC regulatory representatives

Functions, Duties, Task:

• Represent Global CMC Regulatory on cross-functional teams, as assigned, developing robust regulatory strategy.
• Design/develop regulatory strategy and oversee or draft technical regulatory documents.
• Assess manufacturing and quality related change requests.
• Author high-quality CMC documentation (complete registration and/or variation packages), applying global CMC regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements.
• Oversee US Annual Report activities (maintain schedule, collect documents, compile draft reports, coordinate review/approval/submission activities with key subject matter experts, etc.).
• Act as a regulatory technical mentor for junior colleages.
• Facilitate and/or maintain a positive collaboration and partnership with the US CVM
• Prepare manufacturing teams for and lead regulatory agency meetings related to the CMC/quality section.
• Proactively manage conflicting priorities.
• Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions, as applicable

Minimum Qualification (education, experience and/or training, required certifications):

• Minimum Bachelor\xe2\x80\x99s Degree a physical, chemical or life sciences discipline.
• 5 - 8 years experience working in pharmaceuticals and/or regulated environment

Language requirements:

• English

Additional Preferences:

• GMP knowledge and experience
• Knowledge and understanding of QbD and QbR.
• Fundamental knowledge of US regulations.
• Familiarity of global regulatory requirements.
• Familiarity with the chemistry, manufacturing and control components of a registration dossier
• Strong communication skills, both written and oral.
• Self-starter, takes initiative.
• Timeline driven.
• Attention to detail.
• Quality and customer focused mindset.
• Strong organization and an ability to multi-task; able to handle multiple projects at different phases of development at the same time.
• Must be able to speak and to write in English.
• Familiarity with Regulatory Authoring and Archival Tools (Veeva RIM, Quality & Clinical)

Other Information:

• Personal Considerations: Domestic and international travel required
• Travel 0-10%
• Hybrid Schedule (In office 2 days a week)

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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