Director - Regulatory Affairs Job
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Employer: Rising Pharma Holdings Inc
SpiderID: 14173601
Location: East Brunswick, New Jersey
Posted: 4/30/2026
Wage:
Priority Review Date: 7/29/2026
Job Code / NOC / SOC:
Category: General
Job Description:
Director - Regulatory Affairs is needed to perform the following duties :
• Provide strategic leadership for Regulatory Affairs, overseeing NDAs and ANDAs across the full product lifecycle, including development, approval, post-approval changes, and site transfers.
• Lead and direct Regulatory Operations and Labeling functions, ensuring alignment with FDA, ICH, and eCTD requirements.
• Serve as the primary regulatory representative on cross-functional leadership teams, influencing product development and commercialization strategies.
• Define and execute regulatory strategies to support timely approvals and lifecycle management of assigned products.
• Oversee the preparation, review, and approval of high-impact regulatory submissions and responses to USFDA, ensuring accuracy, completeness, and compliance with applicable regulations (21 CFR Parts 201–211).
• Make key regulatory decisions and provide risk-based guidance to ensure successful outcomes in FDA interactions and submissions.
• Establish and enhance regulatory processes, systems, and governance frameworks to improve efficiency and compliance.
• Ensure timely fulfillment of regulatory obligations, including FDA user fees (GDUFA, PDUFA, facility fees) and Drug Establishment Registration renewals (21 CFR 207).
• Maintain compliance with internal policies and global regulatory standards.
• Provide strategic oversight of labeling, including development, review, and approval of commercial artwork and ensuring compliance with FDA labeling regulations (21 CFR Parts 201/202).
• Ensure readiness for product launch by overseeing labeling approvals, drug listing, and regulatory compliance prior to U.S. distribution.
• Drive effective collaboration with contract manufacturing organizations and global stakeholders to support submission readiness and compliance.
• Serve as the primary regulatory representative on cross-functional leadership teams, influencing product development and commercialization strategies.
• Lead organizational planning for Regulatory Affairs, including resource allocation, budgeting, and performance management for 12 direct reports
Bachelor’s degree is required in Pharmacy or Drug Regulatory Affairs or Pharmaceutical Science or Regulatory Affairs
• Provide strategic leadership for Regulatory Affairs, overseeing NDAs and ANDAs across the full product lifecycle, including development, approval, post-approval changes, and site transfers.
• Lead and direct Regulatory Operations and Labeling functions, ensuring alignment with FDA, ICH, and eCTD requirements.
• Serve as the primary regulatory representative on cross-functional leadership teams, influencing product development and commercialization strategies.
• Define and execute regulatory strategies to support timely approvals and lifecycle management of assigned products.
• Oversee the preparation, review, and approval of high-impact regulatory submissions and responses to USFDA, ensuring accuracy, completeness, and compliance with applicable regulations (21 CFR Parts 201–211).
• Make key regulatory decisions and provide risk-based guidance to ensure successful outcomes in FDA interactions and submissions.
• Establish and enhance regulatory processes, systems, and governance frameworks to improve efficiency and compliance.
• Ensure timely fulfillment of regulatory obligations, including FDA user fees (GDUFA, PDUFA, facility fees) and Drug Establishment Registration renewals (21 CFR 207).
• Maintain compliance with internal policies and global regulatory standards.
• Provide strategic oversight of labeling, including development, review, and approval of commercial artwork and ensuring compliance with FDA labeling regulations (21 CFR Parts 201/202).
• Ensure readiness for product launch by overseeing labeling approvals, drug listing, and regulatory compliance prior to U.S. distribution.
• Drive effective collaboration with contract manufacturing organizations and global stakeholders to support submission readiness and compliance.
• Serve as the primary regulatory representative on cross-functional leadership teams, influencing product development and commercialization strategies.
• Lead organizational planning for Regulatory Affairs, including resource allocation, budgeting, and performance management for 12 direct reports
Bachelor’s degree is required in Pharmacy or Drug Regulatory Affairs or Pharmaceutical Science or Regulatory Affairs
Contact Information:
| Contact Name: Rising Pharma Holdings Inc | Type: |
| Company: |