Regulatory Specialist Visa Sponsorship Jobs in New Jersey
Regulatory specialist visa sponsorship jobs in New Jersey are concentrated in the pharmaceutical and life sciences corridor spanning Parsippany, Bridgewater, and Princeton, home to major employers including Johnson & Johnson, Merck, Novartis, and Becton Dickinson. The state's dense concentration of FDA-regulated industries makes it one of the most active markets in the country for sponsored regulatory roles.
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Get Access To All JobsRegulatory Affairs Labeling Operations Specialist
Location: Plainsboro, NJ – Onsite preferred, remote okay
SCHEDULE: Mon-Fri 9am – 5pm
START: 11/30
DURATION: 2 years
TOP 3 MUST HAVES:
1. TVT (Text Verification Tool)
2. SPL (Structured Product Labeling) Creation/Dev
3. Self-Directed Project Management
We are seeking a dynamic and experienced Regulatory Affairs Labeling Operations Specialist (Contractor) 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.
Relationships: Reports to labeling management in Regulatory Operations (RO), engaging with key company personnel to drive successful project outcomes for assigned projects. Develops and maintains positive working relationships with company stakeholders, fostering effective collaboration with Regulatory Affairs (RA), Supply Chain, and HQ colleagues to ensure labeling compliance and accomplish company goals.
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
Essential Functions:
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.
Thanks & Regards,
Vaishnav Gupta | Senior Technical Recruiter
KPG99, INC | MBE Certified Firm
3240 E State, St Ext | Hamilton, NJ 08619
Vaishnav.gupta@kpgtech.com
Regulatory Affairs Labeling Operations Specialist
Location: Plainsboro, NJ – Onsite preferred, remote okay
SCHEDULE: Mon-Fri 9am – 5pm
START: 11/30
DURATION: 2 years
TOP 3 MUST HAVES:
1. TVT (Text Verification Tool)
2. SPL (Structured Product Labeling) Creation/Dev
3. Self-Directed Project Management
We are seeking a dynamic and experienced Regulatory Affairs Labeling Operations Specialist (Contractor) 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.
Relationships: Reports to labeling management in Regulatory Operations (RO), engaging with key company personnel to drive successful project outcomes for assigned projects. Develops and maintains positive working relationships with company stakeholders, fostering effective collaboration with Regulatory Affairs (RA), Supply Chain, and HQ colleagues to ensure labeling compliance and accomplish company goals.
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
Essential Functions:
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.
Thanks & Regards,
Vaishnav Gupta | Senior Technical Recruiter
KPG99, INC | MBE Certified Firm
3240 E State, St Ext | Hamilton, NJ 08619
Vaishnav.gupta@kpgtech.com
Regulatory Specialist Job Roles in New Jersey
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Search Regulatory Specialist Jobs in New JerseyRegulatory Specialist Jobs in New Jersey: Frequently Asked Questions
Which companies sponsor visas for regulatory specialists in New Jersey?
New Jersey's pharmaceutical and medical device sector drives most regulatory specialist sponsorship. Companies with consistent H-1B visa and green card filing histories for regulatory roles include Johnson & Johnson, Merck, Novartis, Bristol Myers Squibb, Becton Dickinson, and Integra LifeSciences. Contract research organizations and regulatory consulting firms operating out of Parsippany and Princeton also sponsor international candidates for these positions.
What visa types realistically fit regulatory specialist roles in New Jersey?
Regulatory specialist roles typically qualify as specialty occupations requiring a directly related bachelor's degree, making H-1B the most common path. Employers file a Labor Condition Application with DOL before submitting an I-129 petition with USCIS. EB-2 and EB-3 employment-based green cards are also common in New Jersey's pharmaceutical sector, with most cases requiring PERM labor certification. F-1 students may use OPT to gain initial work authorization while seeking longer-term sponsorship.
Which cities in New Jersey have the most regulatory specialist sponsorship jobs?
Parsippany-Troy Hills, Bridgewater, and Princeton form the core of New Jersey's regulatory job market, anchored by major pharmaceutical headquarters and R&D campuses. Titusville and Rahway also host significant regulatory functions for large biopharma employers. Jersey City and Newark attract regulatory roles in financial services compliance and medical device distribution, broadening sponsorship opportunities beyond the traditional pharma corridor.
How to find regulatory specialist visa sponsorship jobs in New Jersey?
Migrate Mate lists New Jersey employers with verified visa sponsorship histories for regulatory specialist roles, letting you search specifically within the state's pharmaceutical, medical device, and biotech sectors. Because regulatory titles vary across employers, searching broadly for related terms helps surface more relevant openings. Migrate Mate's focus on verified sponsoring employers saves time compared to filtering through postings that don't disclose visa support.
Are there state-specific factors that affect regulatory specialist sponsorship in New Jersey?
New Jersey's concentration of FDA-regulated industries means regulatory specialists with backgrounds in pharmaceutical submissions, clinical affairs, or quality systems are in particularly strong demand. The state's proximity to the FDA's New Jersey district office and its dense network of biotech incubators and CROs creates a pipeline of employers familiar with sponsoring international talent. Candidates with degrees in pharmacy, biology, chemistry, or engineering generally align well with specialty occupation requirements for these roles.
What is the prevailing wage for sponsored regulatory specialist jobs in New Jersey?
U.S. employers sponsoring a visa must pay at least the prevailing wage, which is what workers in the same role, area, and experience level typically earn. The Department of Labor sets this rate to make sure companies aren't hiring foreign workers simply because they'd accept lower pay than a U.S. worker. It varies by job title, location, and experience. You can look up current prevailing wage rates for any occupation and location using the OFLC Wage Search page.