Regulatory Associate

Sandoz • Sandoz, CA

1d • $70,000 - $130,000 • Hybrid

About The Position

An exciting opportunity to join the Sandoz biosimilar team; and be part of bringing affordable medicines to patients and prescribers. The individual will support the US Biosimilar Regulatory Affairs team and will work with various project teams on licensed products as well as products in development. The individual will be responsible for the operational execution of specific regulatory deliverables (see below) relating to worldwide maintenance, upkeep and lifecycle management of Sandoz biosimilar products on a continual or ad-hoc basis. Location This position will be located at the Princeton, NJ US Headquarters site. Our Sandoz flexible hybrid working approach allows US office-based employees to work up to 50% of their monthly workday remotely. This role will not have the ability to be located remotely. Preference will be given to local candidates not requiring relocation. U.S. Work visa sponsorship not available for this role. Must have U.S. work authorization.

Requirements

• Education & Experience (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.

Nice To Haves

• 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

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

Benefits

• Sandoz offers a generous employee benefits package that includes a competitive salary, health insurance coverage for medical, prescription drugs, dental and vision, a generous company match for retirement savings accounts, and generous paid time off.
• We also follow a hybrid work policy that combines a mix of in-person and remote work to allow our employees flexibility.
• The pay range for this position at commencement of employment is expected to be between $70,000 – 130,000 USD/year; however, while salary ranges are effective from 1/1/26 through 12/31/26, fluctuations in the job market may necessitate adjustments to pay ranges during this period .Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities.
• The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered.
• Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
• If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees