Dossier management services Jobs

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Quick apply
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Regulatory research and Toxicology
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Manager - Regulatory Dossier Services

Elanco -
Bengaluru, Karnataka

Apply Now

Job details

Full-time

Qualifications

Microsoft Word
Project coordination
English
Bachelor's degree
Organizational skills
AI
Document management
Communication skills
Adobe Acrobat
FDA regulations

Full job description

At Elanco (NYSE: ELAN) – it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.

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.

Making animals’ lives better makes life better – join our team today!

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.

Apply Now

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