Sandoz US ยท 15 hours ago
Regulatory Associate
Princeton, CA
Full-time
Onsite
New Grad, Entry Level
$70K/yr - $130K/yrSandoz US is a leader in the global medicines industry, focusing on generic and biosimilar medicines. They are seeking a Regulatory Associate to prepare US eCTD documents, coordinate regulatory activities, and manage high-quality regulatory documents to support the biosimilar pipeline.
Pharmaceuticals
No H1B
Responsibilities
Prepare US eCTD documents for submissions to support the biosimilar pipeline
Coordination of US regulatory activities with the publishing team and other global RA functions as needed (such as submission tracking, document templates, creations of US FDA forms, cover letters, etc)
Management of high-quality regulatory documents and tracking of regulatory activities in relevant IT systems to support team deliverables
Provide support to regulatory teams on project specific needs, as defined by each project
Provide coordination of key regulatory documents/information between various departments
Maintain regulatory archives
Support local regulatory requirements such as preparation of NDC forms, annual reports, etc
Execute and manage operational activities for assigned projects under the supervision of the regulatory teams
Qualification
Required
Bachelor in a science related degree
Experience (internships) in regulatory affairs preferred
Fluent English required (oral and written)
U.S. Work visa sponsorship not available for this role. Must have U.S. work authorization
Preferred
General understanding of drug development and regulatory affairs
Proven expertise in organization and prioritization of tasks
Strong interpersonal, communication and negotiation skills
Ability to quickly familiarize with new IT tools
Ability to work independently, under pressure, demonstrating initiative and flexibility
Ability to operate effectively in an international and cross-functional environment
Strong organizational and planning skills
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
Funding
Current Stage
Growth StageCompany data provided by crunchbase