Job Description Summary
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.

Position 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.

Must be authorized to work in the U.S. U.S. work visa sponsorship is not available for this role now or in the future.

Major Accountabilities / Your Key Responsibilities:

Your responsibilities include, but not limited to:

• Participates in Global RA project meetings & provides input into global strategy for US submissions. Is responsible for implementing the agreed upon strategies for assigned projects
• Prepare US eCTD documents & facilitating timely submissions and approvals to support the biosimilar pipeline
• Management of high-quality regulatory documents and tracking of regulatory activities in relevant IT systems to support team deliverables. Maintain regulatory archive systems.
• Support local regulatory requirements such as preparation of NDC forms, annual reports, etc to ensure compliance with regulatory health authorities.
• Determines requirements and sets objectives for Health Authority (HA) interactions as applicable.
• Coordination of key regulatory information between various departments and participates in launch preparation activities.
• Execute and manage operational activities for assigned projects.

Key Performance Indicators:

• Successful implementation of regulatory strategy for timely submissions and approvals based on available data.
• Pro-active working style demonstrating leadership and embraces the Sandoz cultural principles
• Successful Participation in relevant regulatory teams' meetings, as well as cross functional meetings, and providing valuable input on projects.
• Adherence to Sandoz policy and guidelines -Project & stakeholder feedback

Key Capabilities Required:

• Regulatory & compliance Expertise: Deep understanding of health authorities' regulations and guidance documents associated with drug development, labeling and post-marketing compliance, with the ability to apply this knowledge to ensure seamless execution of submissions, approvals and regulatory compliance activities
• Project & Portfolio Management Expertise: Strong organizational skills and attention to detail with the ability to support multiple regulatory projects simultaneously, managing timelines, priorities, and deliverables across various stages of product development
• Communication and Interpersonal Skills: Strong verbal and written communication skills, with the build professional relationships, actively listen, and communicate with clarity and confidence in a fast-paced, team-oriented environment.
• Analytical and Problem-Solving Skills: Strong analytical thinking and a proactive approach to problem-solving, with the ability to evaluate regulatory requirements, troubleshoot issues, risk mitigation and support decision-making processes with sound judgment and accuracy.
• Writing and Documentation Skills: Professional writing and documentation skills are essential, ensuring all regulatory submissions and internal documentation meet quality, consistency, and compliance standards.

What you'll bring to the role:

Required Qualifications:

Education & Experience (Required):

• Bachelor in a science required
• 3-5 years experience in regulatory affairs, preferably in biosimilars area
• Industry Awareness: Knowledge of existing and upcoming industry trends and regulatory changes.
• Demonstrated understanding of relevant regulations and standards from highly regulated agencies such as the FDA, EMA, and MHRA
• Proficiency in data analysis and regulatory document preparation.
• Experience with HA meetings and communications
• Languages: Fluent English required (oral and written)

Preferred Requirements:

• Ability to work independently, under pressure, demonstrating initiative and flexibility.
• Team spirit and embracing diversity of cultures and personalities.

Travel Requirements: Up to 5%

You'll Receive:

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 $114,100 - 211,900USD/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.

On September 30, 2021, Sandoz entered into a 5-year Corporate Integrity Agreement. Certain positions will have responsibilities to support the execution and adherence to CIA obligations, CIA-related deliverables, and any relevant audit, monitoring or Independent Review Organization (IRO) remediation.

Sandoz - Notice at Collection to Employees Applicants 4.15.24[16].pdf

Salary Range

Skills Desired
Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance