Manager - Regulatory Dossier Services

• 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.

• 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

• 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.

• 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

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