Regulatory Affairs Specialist Job
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Employer: Rising Pharma Holdings Inc.
SpiderID: 14168849
Location: East Brunswick, New Jersey
Posted: 4/20/2026
Wage:
Priority Review Date: 5/20/2026
Job Code / NOC / SOC:
Category: General
Job Description:
Regulatory Affairs Specialist is needed to perform the following duties:
Labeling Submissions to US FDA/CVM
• Responsible for supporting timely preparation, review, and submission of labeling submissions to US FDA/CVM using CVM eSubmitter for Cronus-owned applications (JINADs, NADAs, ANADAs.
NDC, Artwork Codes & Artwork Preparation/Approval
• Responsible for requesting and collecting required information (NDC, artwork codes, pharmacodes, barcodes, material codes) to support labeling activities, and for assisting in the preparation, review, and approval of artworks for Cronus-owned applications (JINADs, NADAs, ANADAs).
SPL and Drug Listing Management
• Responsible for supporting the preparation, review, approval, and updating of SPL and drug listings prior to shipment to the USA, for products distributed under Cronus and private distributor labeler codes for Cronus-owned applications (JINADs, NADAs, ANADAs).
Cross-Functional Coordination with Teams, CMOs & Status Reporting
• Responsible for coordinating with cross-functional teams and CMOs to support completion of labeling activities, and for providing timely updates on labeling activities/status to the department head/supervisor.
Regulatory & Labeling Document Management
• Responsible for maintaining and organizing regulatory and labeling documents in designated systems/drives.
Regulatory Reports & Drug Establishment Registration
• Responsible for assisting in preparation and submission of regulatory reports (antimicrobial reports, DERs, MCSR) and for supporting preparation and submission of drug establishment registration.
Drafting & Updating SOPs for Regulatory and Labeling Activities
• Responsible for assisting in drafting and updating SOPs related to regulatory and labeling activities.
Application Tracking, Commercial Launch Readiness & Regulatory Research
• Responsible for tracking application goal dates/approval dates and keeping artworks ready for commercial launch; and for conducting regulatory research and staying current with US FDA/CVM regulations, guidance updates, and requirements.
Bachelor’s degree is required in Pharmacy or Drug Regulatory Affairs or Pharmaceutical Science or Chemistry
Labeling Submissions to US FDA/CVM
• Responsible for supporting timely preparation, review, and submission of labeling submissions to US FDA/CVM using CVM eSubmitter for Cronus-owned applications (JINADs, NADAs, ANADAs.
NDC, Artwork Codes & Artwork Preparation/Approval
• Responsible for requesting and collecting required information (NDC, artwork codes, pharmacodes, barcodes, material codes) to support labeling activities, and for assisting in the preparation, review, and approval of artworks for Cronus-owned applications (JINADs, NADAs, ANADAs).
SPL and Drug Listing Management
• Responsible for supporting the preparation, review, approval, and updating of SPL and drug listings prior to shipment to the USA, for products distributed under Cronus and private distributor labeler codes for Cronus-owned applications (JINADs, NADAs, ANADAs).
Cross-Functional Coordination with Teams, CMOs & Status Reporting
• Responsible for coordinating with cross-functional teams and CMOs to support completion of labeling activities, and for providing timely updates on labeling activities/status to the department head/supervisor.
Regulatory & Labeling Document Management
• Responsible for maintaining and organizing regulatory and labeling documents in designated systems/drives.
Regulatory Reports & Drug Establishment Registration
• Responsible for assisting in preparation and submission of regulatory reports (antimicrobial reports, DERs, MCSR) and for supporting preparation and submission of drug establishment registration.
Drafting & Updating SOPs for Regulatory and Labeling Activities
• Responsible for assisting in drafting and updating SOPs related to regulatory and labeling activities.
Application Tracking, Commercial Launch Readiness & Regulatory Research
• Responsible for tracking application goal dates/approval dates and keeping artworks ready for commercial launch; and for conducting regulatory research and staying current with US FDA/CVM regulations, guidance updates, and requirements.
Bachelor’s degree is required in Pharmacy or Drug Regulatory Affairs or Pharmaceutical Science or Chemistry
Contact Information:
| Contact Name: Rising Pharma Holdings Inc. | Type: |
| Company: |