Job Title:
Electronic Document Specialist (EDS) Team Lead
Company:
Sanofi
Location:
Hyderabad, India
Job Type:
Full-Time, Permanent
About the Job:
As an EDS Team Lead at Sanofi's Hyderabad Hub, you will manage a team of Electronic Document Specialists responsible for producing high-quality regulatory submissions. You will play a key role in transforming processes, embracing new technologies (including AI), and ensuring compliance with global regulatory standards. This is a leadership role with strategic impact across Sanofi's R&D portfolio.
Main Responsibilities:
1. Team Leadership & People Management
Lead, mentor, and support a team of Electronic Document Specialists.
Set performance goals, conduct evaluations, and provide feedback.
Drive team development and ensure optimal resource utilization.
2. Document Management & Compliance
Oversee preparation, formatting, and compilation of electronic documents for regulatory submissions (e.g., eCTD).
Monitor industry regulations (FDA, EMA, etc.) and ensure compliance in documentation.
Ensure all documentation meets Sanofi’s quality and submission standards.
3. Quality Control
Implement Sanofi QC processes including checklists and audits to ensure document accuracy, completeness, and consistency.
4. Process Optimization
Identify and implement automation and technology improvements to streamline document preparation and increase productivity.
5. Collaboration & Communication
Coordinate with Regulatory Affairs, Clinical Development, Nonclinical, and QA teams to align submission timelines and gather documentation.
Support document migration during mergers/acquisitions.
6. Publishing & Project Management
Manage document compilation and publishing for submissions.
Oversee multiple projects simultaneously, ensuring timely delivery and adherence to regulatory timelines.
7. Continuous Improvement
Foster a culture of continuous feedback and optimization.
Use performance metrics to identify process gaps and implement improvements.
About You:
Experience & Skills
Experience managing electronic document processes and leading teams in the pharmaceutical industry.
Deep knowledge of regulatory submission formats (e.g., CTDs) and global health authority requirements (FDA, EMA).
Proficiency with regulatory systems (e.g., Vault RIM), EDMS tools, Adobe Acrobat, and MS Office Suite.
Strong project management, organizational, and leadership skills.
Excellent verbal and written communication.
Ability to prioritize and manage multiple complex projects in a matrixed environment.
Proven ability to troubleshoot publishing issues and identify effective solutions.
Education
Bachelor's degree or equivalent in Regulatory Affairs, Life Sciences, or a related field.
Languages
Excellent command of English (spoken and written).
Why Join Sanofi:
Purpose-Driven Work: Be part of a team impacting millions of lives through science and innovation.
Career Growth: Explore endless career opportunities across geographies and functions.
Recognition & Rewards: Competitive compensation and recognition for your contributions.
Inclusive Culture: A workplace committed to diversity, equity, and inclusion.
Equal Opportunity Statement:
Sanofi is an equal opportunity employer. All applicants will be considered regardless of race, religion, gender, orientation, age, disability, or any other protected status.
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