Regulatory Affairs Associate I
16 hours ago
We are seeking a highly skilled Regulatory Affairs Associate I to join our team at Collabera. As a key member of our regulatory affairs team, you will be responsible for managing low to medium impact submission projects, ensuring timely delivery of high-quality dossiers that meet technical specifications defined by regulatory authorities.
Key Responsibilities
- Manage submission projects to ensure timely delivery of high-quality dossiers
- Act as RA Submissions support to project teams, providing guidance and communication of established submission processes and standards
- Participate in submission team meetings, expediting, managing, and coordinating multiple concurrent interrelated activities for submission projects
- Anticipate obstacles and propose solutions within the team
- Coordinate submission publishing with offsite publishers, providing notification to ensure all required resources are available to meet submission timelines
- Prepare content planner for publishing and work with vendor to resolve publishing issues
- Perform in-house publishing tasks, facilitate the creation or procurement of submission content deliverables, and perform detailed quality reviews of published output to ensure compliance with regulatory standards and health authority guidelines
Requirements
- Required Education: Bachelor's Degree
- Required Experience: Two years pharmaceutical or industry-related experience
- Preferred experience: Publishing-related software tools, e.g., Documentum, eCTDXPress/ISIPublisher, ISI Toolbox/DocuBridge/Insight platform, Adobe Acrobat
About Collabera
Collabera is a Global Digital Solutions Company providing Software Engineering Solutions for the world's most tech-forward organizations in the areas of Engineering, Cloud, and Data/AI. With its roots serving the engineering needs of the world's most recognized businesses in Technology, Financial Services, Telecom, and Healthcare, Collabera today operates across 60 locations in 11 countries, serves 30% of the Fortune 500, and has exceeded the industry growth rate by 3-4x for several years.
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