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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.

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Position Description: This role is responsible for managing and executing publishing activities for various regulatory submissions within the Global Regulatory Organization. The Manager acts as a subject matter expert (SME) on publishing processes coordinates submission projects and helps ensure the team's outputs are of high quality and delivered on schedule. This role involves mentoring junior staff and contributing to process improvements.

Functions Duties Tasks:

Manage the end-to-end publishing process for regulatory submissions ensuring all components are compiled formatted and published according to global standards.

Serve as a lead publisher and technical SME for assigned projects providing guidance on requirements and timelines to cross-functional teams.

Troubleshoot complex document and publishing issues providing solutions to ensure submission integrity.

Train and mentor Associate Managers and new team members on publishing tools procedures and best practices.

Actively participate in and contribute to process improvement initiatives to enhance efficiency and quality.

Utilize advanced functions of publishing applications (e.g. mono eCTD) and validation tools to prepare and verify submissions for various global markets (e.g. US EU MoW).

Manage submission-related documents and binders within Veeva RIM

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

Bachelor’s Degree or equivalent work experience in a relevant technical or scientific discipline.

5+ years of experience in a regulatory operations document management or publishing role.

Demonstrated experience managing publishing for multiple regulatory submissions.

Proficiency with Microsoft Word and Adobe Acrobat.

Strong attention to detail organizational skills project coordination and planning skills.

Excellent written and oral communication skills in English.

Additional Preferences:

Experience with submissions to major global health authorities (FDA EMA etc.).

Proven ability to lead projects and interact effectively across different geographies and cultures.

May support other operational activities as needed

Ability to work effectively both independently and as part of a global team.

Other Information:

Demonstrate high levels of adaptability flexibility and learning agility.

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.