RA Manager

Benefits

Additional Information

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. Job Description Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape! 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 packag