RA Manager

U023 (FCRS = US023) Sandoz Inc; Princeton (NJ); Hybrid; USD 114,100 - 211,900; Full time

Benefits offered by this job

Health insurance

Generous paid time off

Retirement savings match

Potential sign-on bonus

Job summary

Sandoz Inc in Princeton, NJ, is seeking a Regulatory Affairs professional to join their biosimilar team. This role involves supporting the regulatory strategy and managing documentation for product submissions.

The ideal candidate should have a Bachelor's degree in a science and 3-5 years of experience in regulatory affairs. The position offers a competitive salary range and a flexible hybrid working approach, allowing for up to 50% remote work.

Qualifications

• 3-5 years experience in regulatory affairs, preferably in biosimilars.
• Fluent English (oral and written) required.

Responsibilities

• Participate in Global RA project meetings and provide input into global strategy for US submissions.
• Implement the agreed upon strategies for assigned projects.
• Prepare US eCTD documents and facilitate timely submissions and approvals to support the biosimilar pipeline.

Skills

Regulatory & Compliance Expertise

Project & Portfolio Management Expertise

Communication and Interpersonal Skills

Analytical and Problem-Solving Skills

Writing and Documentation Skills

Education

Bachelor in a science

Job description

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 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.

Key Responsibilities

• Participate in Global RA project meetings and provide input into global strategy for US submissions.
• Implement the agreed upon strategies for assigned projects.
• Prepare US eCTD documents and facilitate timely submissions and approvals to support the biosimilar pipeline.
• Manage high‑quality regulatory documents and track 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.
• Determine requirements and set objectives for Health Authority (HA) interactions as applicable.
• Coordinate key regulatory information between various departments and participate 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 embracing 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, building professional relationships, actively listening and communicating 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: Bachelor in a science required; 3‑5 years experience in regulatory affairs, preferably in biosimilars.
• Industry Awareness: Knowledge of existing and upcoming industry trends and regulatory changes.
• Regulatory Understanding: Demonstrated understanding of relevant regulations and standards from highly regulated agencies such as the FDA, EMA and MHRA.
• Data Analysis & Documentation: Proficiency in data analysis and regulatory document preparation.
• HA Meetings: Experience with HA meetings and communications.
• Languages: Fluent English (oral and written) required.

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% travel.

You’ll Receive

• Competitive salary in the range of $114,100 – $211,900 USD/year, with potential adjustments based on location, experience and market factors.
• Health insurance coverage for medical, prescription drugs, dental and vision.
• Generous company match for retirement savings accounts.
• Generous paid time off, including vacation, sick time and parental leave.
• Potential sign‑on bonus, restricted stock units and discretionary awards.
• Comprehensive medical, financial and other benefits associated with the Sandoz benefits program.

We also follow a hybrid work policy that combines a mix of in‑person and remote work to allow our employees flexibility.

EEO Statement

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Accessibility and Reasonable Accommodations

Sandoz, Inc. is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to [e-mail] or call 1‑609‑422‑4098 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.