RA Manager

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.

• 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.

• 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.

• 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.

• 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…