RA Labeling Senior Associate

Job Description Summary

Job Description

Major accountabilities:

• Consistent and demonstrated mastery of Level I associate responsibilities.

• With direction prepares reviews and submits high quality regulatory labeling submissions to the FDA in accordance with both FDA and internal timelines.

• Responsible for the creation of labeling in SPL format with and without highlights and maintenance of all labeling files in accordance with internal procedures.

• Responsible for the preparation review and submission of SPL to the FDA.

• Responsible for the creation preparation review approval and management of pharmaceutical labeling for submission to FDA based on Reference Listed Drug labeling FDA requirements and company requirements. Also responsible for managing and tracking this process to ensure timely submissions to FDA.

• Responsible for identifying changes needed for FDA approved labeling including updates to Reference Listed Drug USP updates and updates for new regulatory requirements.

  Responsible for the product registrations maintenance of product drug listings and delisting NDC number posting to NDC directory and accuracy of labeling posted to DailyMed.

• Actively participates in team meetings independently tracks FDA labeling changes and implements safety-labeling changes based on departmental work instructions.

• Provides labeling support and guidance to internal and external customers.

• Provides expert support as a regulatory subject matter expert and work closely with cross-functional departments to provide the appropriate regulatory requirements/guidance.

• Stays current with emerging regulatory labeling guidance and industry expectations and standards and demonstrates the ability to translate these into process improvements or best practices.

• Actively looks for ways to improve current processes within department and across the business to gain efficiency and support quality labeling submissions to US FDA.

• Reviews labeling change control requests for completeness and accuracy. Assesses the impact of the changes as they relate to approved ANDAs and/or NDAs and communicates the impact to his/her manager.

• Responsible for the accurate and timely preparation of all labeling components: physician insert patient insert carton/ carton label vial label printed foils etc.

• Manages Drug Listing activities.

• Other functional duties as requested by management.
  

Job Dimensions:

• Follows all procedures and proactively maintains labeling tracking information.

• Makes decisions independently with clear action.

• Effectively prioritizes competing tasks in a fast-paced and dynamic environment.

• Develops and supports process for labeling creation and update.

• Performs duties with the highest ethical standards delivering only high-quality compliant submissions to FDA.

• Demonstrate cordial and respectful service to all customers.

Experience:

• Bachelors degree plus a minimum of 5 years in the pharmaceutical industry with 2 of those years in regulatory affairs labeling.

• Associates degree plus a minimum of 8 years pharmaceutical industry experience with at least 3 years in regulatory affairs labeling.
  

Education:

• Bachelors or associate degree in a scientific discipline or English.

Youll 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$USD/year; however while salary ranges are effective from 1/1/25 through 12/31/25 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.

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!

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 or call 1- and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

Skills Desired