Sandoz US · 2 days ago
Regulatory Affairs Operations Specialist
Princeton, NJ
Full-time
Hybrid
Mid, Senior Level
$94K/yr - $174K/yr
6+ years expSandoz is a global leader in providing sustainable Biosimilar and Generic medicines. The Regulatory Affairs Operations Specialist role involves managing cross-functional team deliverables, facilitating discussions on data challenges, and ensuring compliance with FDA submission processes.
Pharmaceuticals
Responsibilities
Engages with cross-functional teams and independently manages deliverables with SME confirmation. Must effectively communicate without authority
Facilitates discussions to explore data challenges with the goal of driving sound decisions. Where appropriate, pushes for most favorable outcomes and solutions
Embraces digital and technological strategies to improve outcomes. Identifies opportunities, assess’ s for practicality, and builds sensible justifications. Including being a representative on business process validation and implementation
Demonstrates excellent communication skills; listens to audience and tailors messaging appropriately. Builds and leverages network to proactively address challenges and champion improvements
Facilitates, and when required, leads cross functional team meetings
Support harmonization process for efficiency
Update and maintain procedures
Supports drug product registration data and submission process through the accurate and timely completion of activities
Make and support decisions with independently clear actions
Effectively prioritizes competing tasks in a fast-paced and dynamic environment
Develops and supports process for data governance creation and update
Follows all procedures and proactively maintain all training I system/ information
Perform duties with the highest ethical standards, delivering only high-quality, compliant submissions to FDA
Accepts responsibility for results and outcomes and honors all commitments
Is a cooperative partner and works well with others for the benefit of the organization
Maintains a high degree of professionalism; builds trust with leadership and peers
Demonstrates ability to maintain focus and performance when faced with emergency situations; recovers from setbacks and demanding activities
Communicates confidently with superiors and peers; is transparent in all requests and responses
Qualification
Required
Bachelor's or associate degree in Information Management System, Information Management, Computer Science, Programming or Liberal studies
Minimum of 6 years in the pharmaceutical industry with 4 plus of those years in regulatory affairs operations
Regulatory submissions (publishing) background
System/data experience
Preferred
Advanced degree (masters) preferred
Project Management (A plus), GMP, Problem solving, Documentation and communication
Technical Software: MS Office Suite (Word, PowerPoint, Excel, Access, Outlook, MS Project), Adobe acrobat Pro, and Veeva vault
Benefits
Health insurance coverage for medical, prescription drugs, dental and vision
A generous company match for retirement savings accounts
Generous paid time off
401(k) eligibility
Various paid time off benefits, such as vacation, sick time, and parental leave
Company
Sandoz US
Sandoz is the global leader in generics and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients.
201-500 employees
H1B Sponsorship
Sandoz US 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 (7)
2024 (7)
2023 (6)
2022 (9)
2021 (11)
2020 (9)
Funding
Current Stage
Growth StageCompany data provided by crunchbase