Fusion Life Sciences Technologies LLC ยท 1 hour ago
Regulatory Affairs Associate
Florham Park, NJ
Contract
Onsite
Entry Level
2+ years expFusion Life Sciences Technologies LLC is seeking a Regulatory Affairs Associate to manage submission projects involving cross-functional teams. The role involves establishing submission content planners, facilitating meetings, and ensuring compliance with regulatory standards for high-quality submissions.
Data ManagementLife SciencePharmaceuticalStaffing Agency
Hiring Manager
Vijaya Bandi
Responsibilities
Manages low to medium impact (with respect to internal visibility, risk, complexity and criticality) submission projects to ensure the timely delivery of high quality dossiers that meet technical specifications defined by regulatory authorities and can be easily navigated and reviewed by a regulatory agency
Acts as RA Submissions support to project teams providing guidance and communication of established submission processes and standards. Provides input to project publishing timelines and deliverables
Participates in submission team meetings. Expedites, manages, and coordinates multiple concurrent interrelated activities for submission projects in the delivery of low to moderately complex published submissions within the required timelines. Anticipates obstacles and proposes solutions within the team
Coordinates submission publishing with offsite publishers/provides notification to ensure all required resources are available to meet submission timelines. Prepares content planner for publishing and works with vendor to resolve publishing issues. May perform in-house publishing tasks
Facilitates the creation or procurement of submission content deliverables such as cover letters and forms
Performs detailed quality reviews of published output to ensure compliance with Regulatory Standards and Health Authority guidances including verification of content, bookmarks, hypertext links and tables of content in low to moderately complex submissions. Facilitates team reviews
Contributes to the development of optimal business processes and standards within the department to ensure high levels of customer support and to achieve high quality submissions
Contributes to the implementation of internal process and standards documents relating to publishing and publishing deliverables
Suggests and contributes to process improvements, including changes to software and business processes. May participate on internal project teams to update business software
Demonstrates ability to influence without direct authority. Builds and maintains positive relationships internally and externally
Position accountability/scope: oSupervision required. Receives project assignments from manager but has responsibility for managing own projects with oversight. Reviews project progress with manager on a regular basis with direction provided by manager. May assist with onboarding staff
Qualification
Required
Bachelor's Degree
Two years pharmaceutical or industry related experience
Preferred
Publishing related software tools e.g. Documentum
eCTDXPress/ISIPublisher
ISI Toolbox/DocuBridge/Insight platform
Adobe Acrobat
Company
Fusion Life Sciences Technologies LLC
Fusion Life Sciences Technologies (www.fusionlifesolutions.com ) is a WBE-certified Healthcare Staffing and Engineering Services provider supporting industries including Pharma, Medical Devices, Aeronautical, Supply Chain, Heavy/Light Industrial, Food & Beverage, and Automotive.
201-500 employees
H1B Sponsorship
Fusion Life Sciences Technologies LLC has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (57)
2024 (95)
2023 (116)
2022 (135)
2021 (128)
2020 (133)
Funding
Current Stage
Growth StageLeadership Team
R
Rohith Kumar
Executive Partner
Company data provided by crunchbase