Manager – Regulatory Dossier Services
Company: Elanco
Location: Bangalore, Karnataka, India
Job Type: Full-Time
Department: Global Regulatory Organization
Experience: 5+ Years
About the Role
Elanco is seeking a Manager – Regulatory Dossier Services to manage and execute regulatory publishing activities for global regulatory submissions. The role involves leading submission publishing projects, ensuring compliance with global regulatory requirements, supporting dossier management activities, and serving as a Subject Matter Expert (SME) for publishing tools and processes.
The successful candidate will collaborate with global cross-functional teams, mentor junior colleagues, and contribute to process improvement initiatives while ensuring high-quality and timely regulatory submissions.
Key Responsibilities
Regulatory Publishing & Submission Management
Manage end-to-end publishing activities for regulatory submissions.
Compile, format, validate, and publish submission dossiers according to global regulatory requirements.
Ensure submission packages are complete, accurate, and submission-ready.
Support regulatory submissions across multiple global markets.
Project Leadership & Coordination
Act as Lead Publisher for assigned regulatory projects.
Coordinate submission timelines and deliverables with cross-functional stakeholders.
Provide guidance on publishing requirements, timelines, and submission strategies.
Manage multiple submission projects simultaneously.
Technical Expertise & Compliance
Serve as Subject Matter Expert (SME) for regulatory publishing processes and systems.
Troubleshoot complex publishing and document management issues.
Ensure compliance with global regulatory standards and submission requirements.
Perform submission validation and quality checks before final dispatch.
Training & Team Development
Train and mentor Associate Managers and new team members.
Share best practices related to publishing tools, systems, and workflows.
Support capability-building initiatives within the regulatory operations team.
Process Improvement
Participate in continuous improvement initiatives.
Identify opportunities to improve efficiency, quality, and submission timelines.
Contribute to standardization and optimization of publishing processes.
Regulatory Systems Management
Manage submission-related documents within Veeva RIM.
Utilize publishing platforms and validation tools including:
eCTD Publishing Systems
Veeva RIM
Adobe Acrobat
Microsoft Word
Support submissions for FDA, EMA, and other global health authorities.
Required Qualifications
Education
Bachelor's Degree in:
Life Sciences
Pharmacy
Biotechnology
Regulatory Affairs
Scientific or Technical Discipline
Experience
Minimum 5 years of experience in:
Regulatory Operations
Regulatory Publishing
Document Management
Submission Management
Experience managing multiple global regulatory submissions.
Experience working within global regulatory environments.
Required Skills
Regulatory Publishing
eCTD Publishing
Regulatory Operations
Dossier Management
Submission Management
Veeva RIM
Document Management
Regulatory Compliance
FDA Submissions
EMA Submissions
Publishing Validation Tools
Project Management
Stakeholder Management
Quality Review
Microsoft Word
Adobe Acrobat
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