Senior Regulatory Compliance Leader – Global Submissions

Sun Pharmaceutical Industries, Inc.; Princeton (NJ); Presencial; USD 137.000 - 168.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonus plan

Medical/dental/vision coverage

401(k) savings plan

Descripción de la vacante

Sun Pharmaceutical Industries, Inc in Princeton, NJ seeks a Senior Regulatory Compliance Manager to lead QA assessments across global regulatory activities for clinical development and labeling compliance of innovative medicines. The role ensures regulatory submissions, quality systems, and vendor deliverables meet global requirements.

Ideal candidates have 10+ years in Development QA or regulatory compliance, strong knowledge of GxP, and experience with international submissions.

Formación

• 10+ years of experience in Development Quality Assurance, Regulatory Compliance or related GxP-regulated pharma functions.
• Experience supporting global regulatory submissions for innovative medicines.
• Travel 15–25% domestically and internationally.

Responsabilidades

• Lead independent quality reviews of regulatory labelling in global submissions strategies.
• Collaborate with Global Regulatory Affairs, Clinical Development, and external providers to ensure compliance with global regulations.
• Represent QA on labeling governance committees and drive strategic quality decisions.
• Maintain expertise in GCP, GMP, GDP, ICH guidelines and risk-based mitigation strategies.
• Provide oversight during health authority interactions and inspections and support regulatory activities.
• Review INDs/CTAs/annual reports, and ensure translations and certificates are compliant.

Conocimientos

GxP knowledge

Regulatory compliance

Quality systems

ICH guidelines

Educación

Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, or related field

Descripción del empleo

Sun Pharmaceutical Industries, Inc in Princeton, NJ seeks a Senior Regulatory Compliance Manager to lead QA assessments across global regulatory activities for clinical development and labeling compliance of innovative medicines. The role ensures regulatory submissions, quality systems, and vendor deliverables meet global requirements.

Ideal candidates have 10+ years in Development QA or regulatory compliance, strong knowledge of GxP, and experience with international submissions.