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The Fountain Group is currently seeking a Regulatory Affairs Labeling Operations Specialist  for a prominent client of ours. This position is located at Plainsboro, NJ (Onsite Preferred; Remote Considered). Details for the position are as follows:

Regulatory Affairs Labeling Operations Specialist
Location: Plainsboro, NJ (Onsite Preferred; Remote Considered)
Pay Rate: $55- $66.48/hr
Duration: 2-Year Contract (Extension or Conversion Potential)
Schedule: Monday–Friday, 9:00 AM–5:00 PM

Job Description

Seeking an experienced Regulatory Affairs Labeling Operations Specialist to support pharmaceutical labeling development, verification, and lifecycle management for commercial product launches and established brands. The role focuses on proofreading draft and final artwork proofs, Structured Product Labeling (SPL) creation, electronic labeling verification, and regulatory compliance with FDA and Health Canada requirements.

• Review and proofread draft and final printed labeling artwork, including package inserts, leaflets, carton labels, container labels, and device labels.

• Develop, create, review, and maintain Structured Product Labeling (SPL) documents and related regulatory submissions.

• Perform electronic labeling comparisons and verification using Text Verification Tools (TVT) and other comparison systems.

• Ensure labeling compliance with FDA regulations, 21 CFR, Physician Labeling Rule (PLR), and applicable regulatory requirements.

• Coordinate labeling projects with Regulatory Affairs, Graphic Design, Supply Chain, Global HQ, and other cross-functional teams.

• Develop project plans, track timelines, identify project risks, and implement mitigation strategies.

• Support FDA submissions, including SPL Drug Listings, FDA Form 2253, and product/establishment registrations.

• Support labeling process and system improvements using Veeva Vault RIM, LIFT, and other labeling platforms.

Education

• Bachelor's degree in Regulatory Affairs, Life Sciences, Pharmacy, or a related discipline.

• Minimum 3 years of progressively responsible pharmaceutical, biotechnology, or related industry experience; equivalent education and experience may be considered.

Required Skills

• 3–5 years of pharmaceutical regulatory labeling experience.

• Hands-on experience with Structured Product Labeling (SPL) creation, development, and maintenance.

• Proficiency with Text Verification Tools (TVT) or equivalent electronic labeling comparison tools.

• Experience proofreading and reviewing draft and final pharmaceutical artwork proofs.

• Knowledge of FDA labeling regulations, 21 CFR, PLR, SRPI, Medication Guides, and Instructions for Use (IFUs).

• Experience with regulatory labeling submissions and eCTD processes.

• Proficiency with Veeva Vault RIM, ALiCE, LIFT, and related labeling systems.

• Knowledge of FDA and Health Canada labeling requirements.

• Independent end-to-end project management of labeling activities.

Preferred Skills

• Experience supporting established pharmaceutical brands rather than generic products.

• Experience with ALiCE A4L, novoGlow, Veeva Vault Registrations, and LIFT Artwork Management.

• Experience with FDA portals and systems, including ESG NexGen, FURLS, FDALabel, and Drugs@FDA.

• Knowledge of FDA Form 2253, FDA Establishment Registrations, Annual Reports, SPL Blanket No Change Certification, and Puerto Rico registrations.

• Experience with product lifecycle labeling management and commercial product launches.

• Experience with process and system improvements related to labeling and product/establishment registrations.
  
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Payrate: $66.00 - $66.00/hr
 
Summary:
We are seeking a dynamic and experienced Regulatory Affairs Labeling Operations Specialist to process critical tasks related to final printed pharmaceutical labeling for launch and lifecycle management projects guided by company content of labeling, FDA Patient Labeling Resources, FDA Label Negotiations and Industry trends. This requires labeling verification to include reviews across the product family of leaflets, carton and container labels as well as device labels. The ideal candidate will collaborate with cross-functional teams of Regulatory Affairs Therapeutic Area (TA) Managers, Global HQ, Labeling Projects and Planning Coordinators (LPPC), Graphic Designers, Marketing and Supply Chain.
 
Key Responsibilities:

• Review and provide regulatory guidance on commercial labeling materials to ensure compliance with CFR and FDA labeling requirements
• Identify labeling issues, troubleshoot, and communicate effectively with relevant stakeholders to ensure timely resolution
• Monitor, evaluate, and recommend improvements to labeling processes, quality, and system tools, in alignment with FDA regulations and industry best practices

• Label Development:

• Assist in the Final Printed Labeling review and approval process based on final approved labeling content from FDA, collaborating with TA, LPPC, and Graphic Designers to ensure successful on-time launch of product labeling per company launch readiness timelines
• Ensures additional filing requirements are completed for approved content of labeling to include SPL Drug Listing, FDA 2253s and Puerto Rico Registrations

• Labeling Tools:

• Serve as an experienced user in all labeling tools with emphasis in SPL ALiCE A4L environment and highly proficient in TVT usage; other systems include Vault RIM (Veeva), Esko (LIFT Artwork Management), Adobe Acrobat, etc. As well as coordinating technical support needs with internal IT groups
• Utilizing FDA portals and tools to include ESG NexGen, FURLS, SPL Help Desk, FDALabel, Drugs@FDA and coordinating with internal groups and external agencies to resolve any issues

• Regulatory Support:

• Participate in cross-functional teams locally and globally, demonstrating good judgment in troubleshooting to resolve problems of moderate scope and complexity
• Competence in Lot Distribution Data Reports, CARES Act Distribution Reporting, SPL Blanket No Change Certification, FDA Establishment Registrations, FDA Annual Reports, FDA PBRER, Certificate of Pharmaceutical Products, and PRDOH Puerto Rico Registrations

 
Skills and Experience:

• Bachelor's degree and minimum 3 years of progressively responsible experience in a pharmaceutical, biotechnology or related environment OR equivalent combination of experience and education with a concentration in labeling development and maintenance.
• 3-5 years of proven experience supporting process (brand experience is preferred over generics - but depends on candidate's experience)
• Proficiency with 21 CFR Labeling, Physician Labeling Rule (PLR), Selected Requirements of Prescribing Information (SRPI), FDA Patient Labeling Resources, Medication Guides, Instructions for Use, National Drug Codes, industry-standard labeling trends, DUNS, and FEI Registrations.
• Excellent communication, collaboration, and interpersonal skills to work effectively with cross-functional teams and key company personnel.
• Strong problem-solving abilities with a keen attention to detail and adherence to federal requirements and best practices.
• Proven ability to independently manage labeling processes, prioritize tasks, and drive successful outcomes.

 
Top 3 must haves:

• TVT (Text Verification Tool)
• SPL (Structured Product Labeling) Creation/Dev
• Self-Directed Project Management End-to-End

 
Pay Transparency: The typical base pay for this role across the U.S. is: $66.00 - $66.00/hr. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law. 

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Responsibilities:

• Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
• Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).
• Review/approval of engineering study protocols/reports and validation study protocols/reports.
• Review and approval of manufacturing changes for Class III implantable medical devices.
• May require an advanced degree and 3 to 5 years of direct experience in the field.
• Recent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations.
• Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks.
• May lead and direct the work of others. A wide degree of creativity and latitude is expected

Required Experience:

• 6 years pharmaceutical or industry related experience.
• 3-5 years in quality systems or cross-functional project management

Preferred Experience:

• 6 years pharmaceutical experience including 5 years in regulatory affairs or 5 years in Discovery, R&D, or Manufacturing
• Experience working in a complex and matrix environment
• Strong oral and written communication skills
• This contractor will work with internal and external partners in order to deliver products to patients.
• Prepare regulatory submissions, including new applications and amendments, renewals, annual reports, supplements and variations under limited supervision and responds to regulatory information.
• Analyzes and interprets information that impacts regulatory decisions. Seeks expert advice and technical support as required for strategies and submissions
• Manages preparation for agency meetings and manages content of pre-meeting submissions.
• Manages products and change control with an understanding of regulations and company policies and procedures.

Required Education:

• Bachelor's degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject.

Job Description:
Regulatory Affairs Senior Associate
The purpose of this role is to execute OTC regulatory activities for new products registrations and life cycle. Maintenance for the portfolio of products defined by the US Business Units.

Key Responsibilities:

• These responsibilities include some of the following...
• Represent USRA on assigned projects, provide guidance on OTC drug regulatory pathways (monograph,
• NDA).
• Develop regulatory strategies and documents for new product launches and maintenance of current products
• aligned with the regulations
• Develop regulatory label for OTC products, review claims and copy
• Participate in the review of promotional materials
• Support end-to-end regulatory compliance of products in remit.
• Applies system and procedure updates to maintain up to date technical product records
• Identifies and participates in process improvements within US Regulatory Affairs
• Interact with colleagues in other global functions to support global programs
• Effectively communicates regulatory technical requirements and guidelines, facilitating timely and complete
• submissions
• Develop up-to-date knowledge of guidelines and regulatory requirements, as well as technical trends

Qualifications:

• Bachelor s degree in Pharmaceutical or Life Sciences or equivalent regulatory experience
• 2-4 years experience in regulatory affairs including chemistry, manufacturing and controls, and over the
• counter experience, preferably within a Client/Consumer Healthcare/Pharma related industry.
• Experience and knowledge in Quality, product development and manufacturing areas.
• Experience working on FDA applications, OTC monograph products, chemistry, manufacturing and controls
• Proficient knowledge in US FDA regulations
• Regulatory Affairs Senior Associate
• Excellent communications skills, stakeholder management and enjoys working in multidisciplinary teams
• Ability to manage prioritize projects of high complexity
• Experience leading end-to-end regulatory process in new product launches

Additional Preferred Qualifications:

• Knowledge and experience of US regulatory framework for OTC drugs, OTC medical devices
• Ability to ensure compliance standards and key performance indicators are met
• Regulatory expertise in knowledge of the regulatory lifecycle
• Ability to interact at many levels
• Technical knowledge
• Minimum 2 years of experience in regulatory affairs

Competencies and Skills:

• Agile, attention to detail, written and verbal communication skills using evidence and applying judgement to
• balance pace, rigor and risk

Summary:

• The Manager, Process Excellence within Regulatory Affairs is responsible for managing key process excellence and issue management activities that support compliant, efficient, and inspection-ready Regulatory Affairs operations.
• This role oversees the Regulatory Affairs Issue and CAPA Management system (RAIM), triages issue records, escalates issues to Exception Reports when warranted, and partners cross-functionally to drive process improvements.
• Through collaboration with functional and cross-functional stakeholders, the position also supports inspection readiness and audit/inspection response activities, and management of change plans for legacy company integrations into Regulatory Affairs business processes.

Key Responsibilities:

• Manage the Regulatory Affairs Issue and CAPA Management system (RAIM) to ensure issues are appropriately logged, assessed, tracked, and resolved.
• Triage RAIM issue records to determine severity, impact, and appropriate next steps.
• Escalate issue records to Exception Reports when needed based on risk, compliance impact, or process significance.
• Project manage Exception Reports in partnership with cross-functional stakeholders to identify root causes, drive corrective actions, and improve Client processes.
• Collaborate with Regulatory Affairs leaders, Business Process Owners, Quality, and other functions to ensure issue management activities are timely, well-coordinated, and effective.
• May provide support during internal and external audits and inspections, including coordination of documentation, issue follow-up, and response support as needed.
• Manage multiple legacy company integrations for Regulatory Affairs business processes through change plans in OneTrack.
• Ensure process documentation, issue records, and change plans are maintained accurately and in alignment with applicable governance expectations.
• Partner with stakeholders to support effective communication, implementation, and adoption of process changes.

Required Education:

• Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology or related subject). Preferred Education: Relevant advanced degree in science or business is preferred.
• Certification a plus

Required Experience:

• 5+ years of regulatory, pharmaceutical or device experience.
• Experience in Regulatory Affairs, Quality, process excellence, business process management, or related roles is preferred
• Experience managing issue/CAPA systems, exception reporting, or comparable compliance and investigation workflows.
• Experience supporting audit and inspection readiness in a regulated environment.
• Strong organizational, analytical, communication, facilitation, and stakeholder management skills.
• Ability to manage multiple priorities and work effectively across functions and levels.
• Ability to influence without direct authority and work in a matrixed environment.

Location and Schedule:

• This role is 100% remote.
• Work hours must align to EST or CST, first shift.

Top Skills:

• Compliance experience in the wireless industry.
• Knowledge of federal and state rules on tower height, lighting, and environmental requirements.
• Experience reviewing scopes of work and drawings.
• Experience managing backlogs and delays.
• Experience preparing FCC and FAA applications.

Job Summary:

• Prepare and file FCC and FAA applications for tower erection, modifications, and antenna installations.
• Review permits and documents to ensure compliance with regulations and company policies.
• Review and approve or deny Regulatory Notice to Proceed (RNTP) for tower sites.

Requirements:

• Bachelor's degree in a related field or equivalent work experience.
• At least 2 years of regulatory compliance experience.
• Knowledge of the wireless communications industry.
• Knowledge of government administrative procedures and requirements.
• Strong attention to detail.
• Excellent PC skills.
• Excellent written and verbal communication skills.
• Strong organizational and interpersonal skills.
• Ability to work independently.
• Experience with FAA Forms 7460-1 and 7460-2.
• Experience with FCC Form 854 and state Department of Transportation applications.
• Ability to work with supporting documents such as site surveys and U.S.G.S. quad maps.
• Experience with pre-construction evaluation, permitting, and NEPA review.

Responsibilities:

• Review scopes of work for modifications, collocations, and new easements to determine regulatory needs.
• Apply federal and state regulations and internal policies to ensure compliance.
• Prepare and submit FCC and FAA filings and supporting documentation.
• Produce and manage electronic regulatory filings and maintain accurate records.
• Review and approve RNTPs and track documentation and approvals.
• Build and maintain relationships with FCC, FAA, and local, state, and federal offices.