Regulatory Labeling Specialist

Jobs via Dice; Plainsboro Township (NJ); Remote; USD 95,000 - 110,000; Full time

Job summary

A leading company in regulatory affairs is looking for a Regulatory Labeling Specialist to support labeling activities for FDA submissions. This full-time role offers the flexibility of remote work and a competitive salary range, making it an excellent opportunity for professionals with experience in labeling development and regulatory processes.

Benefits

20 days of PTO

401k benefits

Medical, Dental, and Vision insurance

Qualifications

• Minimum 4 years of experience in pharmaceutical, biotechnology or related environment.
• Demonstrated ability to work cross-functionally.
• Knowledge of FDA and Health Canada eCTD submissions lifecycle.

Responsibilities

• Supports the development of labeling activities for regulatory submissions.
• Maintains product and establishment registrations for FDA compliance.
• Participates in cross-functional teams focused on regulatory labeling operations.

Skills

Labeling Development

SPL Preparation and Submission

Strong Technical Knowledge of Systems/Software

Education

Bachelor's degree

Tools

LIFT

Veeva Vault

ALiCE

TVT

NovoGlow

Job description

1 week ago Be among the first 25 applicants

Dice is the leading career destination for tech experts at every stage of their careers. Our client, System One, is seeking the following. Apply via Dice today!

Job Title: Regulatory Labeling Specialist

Compensation: $95000 - $110000 annually depending on years of experience

Location: Can be fully remote

Employee Classification: Joule FTE - Salary + 20 days of PTO + 10 Holidays - 401k benefits/etc.

JOB TITLE : Labeling Specialist - REGULATORY OPERATIONS

LOCATION : Can be onsite/remote or hybrid

MUST HAVES:

• LABELING DEVELOPMENT
• SPL PREPARATION AND SUBMISSION
• STRONG TECHNICAL KNOWLEDGE OF SYSTEMS/SOFTWARE: LIFT, ALiCE, Veeva Vault, TVT, NovoGlow
• MINIMUM 3- 5 YEARS LABELING EXPERIENCE
  
  

PURPOSE: The Labeling Specialist supports the development of labeling activities for all regulatory submissions. This individual collaborates cross-functionally and applies skills and knowledge of drug development and how it relates to labeling operations and requirements to manage the execution of final packaging materials for product launch. This individual also supports the systems and processes by which regulatory labeling items are created, approved, submitted and maintained for use.

The Labeling Specialist is also responsible for maintaining product and establishment registrations (drug/establishment listings) and submission to FDA databases. This individual acts as the Subject Mater Expert (SME) for electronic reports that are FDA compliant and with the required format (e.g., Structured Product Labeling (SPL), Lot Distribution Data (LDD), etc) and that is in alignment with the regulatory strategy.

This individual works cross-functionally with internal and external departments on Regulatory Affairs labeling related issues.

RELATIONSHIPS:

• Reports to labeling management in Regulatory Operations and Innovation.
• Develop and maintain positive rapport and working relationships with company stakeholders.
• Effective collaboration with Regulatory Affairs, CMR, Supply Chain, and HQ colleagues regarding labeling compliance to accomplish company goals.
• External relationships may include interaction with FDA personnel, IT vendors and HQ colleagues regarding assigned projects and roles.
  
  

ESSENTIAL FUNCTIONS:

• Participates on cross-functional teams focused on the planning and execution of regulatory labeling operations. This includes anticipating labeling obstacles, identifying emerging issues and proactively developing solutions.
• May participate in FDA submission planning meetings to ensure clear communication of the project plan, actions items, risks, and decisions to the team as it relates to labeling operation processes.
• Ensures that all regulatory labeling items and information is appropriately tracked, archived, searchable and accessible.
• Enters and monitors project and data in Regulatory Label Management systems (LIFT, SPL, ALiCE, novoGlow, etc.).
• Works directly with Regulatory Project Mangers to prepare labeling items consistent with content project plans.
• Participates locally and globally in initiatives focused on the improvement of regulatory labeling processes and tools (LIFT, Veeva Vaults, TVT, ALiCE, novoGlow, etc.). This includes contributing to new regulatory processes and providing training support as appropriate.
• Contributes to the development of SOPs, Work Instructions (WIs) and training materials required to support regulatory labeling-related activities. Updates internal processes to ensure compliance with health authority requirements and expectation.
  
  

QUALIFICATIONS:

• A Bachelors degree required and minimum 4 years of progressively responsible experience in a pharmaceutical, biotechnology or related environment OR equivalent combination of experience and education required with a concentration in labeling development and maintenance.
• Demonstrated ability to work cross-functionally to develop project plans; proactively identify risks; develop risk mitigation strategies; communicate project team decisions and project status.
• Demonstrated ability and knowledge to participate in process/system improvements related to labeling and product/establishment registrations (LIFT, Veeva Vaults RIM, Registrations, and SPL).
• May be responsible for managing projects, processes, or programs with manager oversight.
• Knowledge of FDA and Health Canada eCTD submissions lifecycle management and associated guidance's/specifications/regulations.
• Proficiency with Microsoft Office, Veeva Vault, TVT, ALiCE, LIFT, novoGlow and other labeling systems
• Excellent verbal and written communication and skills.
• Ability to work independently and collaboratively, in a fast-paced environment consisting of local and global team members.
  
  

System One, and its subsidiaries including Joul, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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Ref: #568-Clinical

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Legal

• Industries

  Software Development

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