Job Description Summary

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.

Job Description

Major accountabilities / Your Key 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.
   

What you’ll bring to the role:
 

Required Qualifications:

Education:

• Bachelor’s or associate degree in Information Management System

• Advanced degree (masters) preferred.
   

​Work Experience:

• Minimum of 6 years in the pharmaceutical industry with 4 plus of those years in regulatory affairs operations.
   

Desirable Requirements:

• Project Management (A plus), GMP, Problem solving, Documentation and communication

• Technical Software: MS Office Suite (Word, PowerPoint, Excel, Access, Outlook, MS Project), Adobe acrobat Pro, and Veeva vault.

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 $93,800 – $ 174,200  USD/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

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported!

Join us!

#Sandoz

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 [email protected] 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.

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Salary Range

$0.00 - $0.00

Skills Desired

Analytical Skill, Clinical Trials, Collaboration, Detail-Oriented, Lifesciences, Project Planning, Regulatory Compliance