RA Specialist

Sandoz • Sandoz, CA

2d • Hybrid

About The Position

The RA Specialist is responsible for supporting Sandoz’ business, regulatory affairs drug product registration data, product life cycle management, support business process validation, collaborate in process discussion and preparing, reviewing, and submitting submissions to the FDA as well as tracking, indexing and documenting information in a compliant and efficient manner. Independent contributor with direction, process oriented, knowledge of FDA guidelines and regulations, and Sandoz internal policies and procedures to not only work on the data management and process but own projects. Liaise and collaborate with all stakeholders to support and work on harmonization processes, system/ process subject matter expert (SME) and provide strategize operation guidance. 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. Preference will be given to local candidates not requiring relocation. Travel Requirements: Occasional travel, up to 5%.

Requirements

• Education: Bachelor’s or associate degree in Information Management System
• Work Experience: Minimum of 6 years in the pharmaceutical industry with 4 plus of those years in regulatory affairs operations.
• Technical Software: MS Office Suite (Word, PowerPoint, Excel, Access, Outlook, MS Project), Adobe acrobat Pro, and Veeva vault.

Nice To Haves

• Advanced degree (masters) preferred.
• Project Management (A plus), GMP, Problem solving, Documentation and communication

Responsibilities

• Engages with cross-functional teams and independently manages deliverables with SME confirmation. Must effectively communicate without authority.
• Facilitates discussions to explore data challenges with the goal of driving sound decisions. Where appropriate, pushes for most favorable outcomes and solutions.
• Embraces digital and technological strategies to improve outcomes. Identifies opportunities, assess’ s for practicality, and builds sensible justifications. Including being a representative on business process validation and implementation.
• Demonstrates excellent communication skills; listens to audience and tailors messaging appropriately. Builds and leverages network to proactively address challenges and champion improvements.
• Facilitates, and when required, leads cross functional team meetings.
• Support harmonization process for efficiency
• Update and maintain procedures
• Key performance indicators: Supports drug product registration data and submission process through the accurate and timely completion of activities.
• Make and support decisions with independently clear actions
• Effectively prioritizes competing tasks in a fast-paced and dynamic environment.
• Develops and supports process for data governance creation and update
• Follows all procedures and proactively maintain all training I system/ information.
• Perform duties with the highest ethical standards, delivering only high-quality, compliant submissions to FDA.
• Accepts responsibility for results and outcomes and honors all commitments.
• Is a cooperative partner and works well with others for the benefit of the organization.
• Maintains a high degree of professionalism; builds trust with leadership and peers.
• Demonstrates ability to maintain focus and performance when faced with emergency situations; recovers from setbacks and demanding activities.
• Communicates confidently with superiors and peers; is transparent in all requests and responses.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree
• Number of Employees: 5,001-10,000 employees