Global Regulatory Compliance Lead for IP Submissions

SUN PHARMA; Princeton (NJ); On-site; USD 137,000 - 168,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Life insurance

Disability insurance

401(k) plan

Flexible spending accounts

Paid time off

Job summary

SUN PHARMA in Princeton, NJ is seeking a Senior Regulatory Compliance Manager to provide independent QA assessment of global regulatory compliance activities supporting clinical development and labeling for IP assets. You will ensure submissions, quality systems, and vendor deliverables meet global requirements and drive inspection readiness.

Responsibilities include leading quality reviews of labeling, partnering with Regulatory Affairs, Clinical Development, and QA teams, and advising on

Qualifications

• Bachelor's degree in Life Sciences or related field; advanced degree preferred.
• Minimum 10 years in Development QA, Regulatory Compliance or related GxP areas.

Responsibilities

• Lead independent quality reviews of regulatory labeling in global submissions strategies for all assigned Innovative Medicines assets.
• Collaborate with Global Regulatory Affairs, Clinical Development, and QA to ensure compliance with global regulations and internal standards.
• Represent Development Quality Assurance on labeling governance committees to influence submission success.
• Maintain expertise in GCP, GMP, GDP, ICH guidelines and lead risk assessments in line with ICH Q9.
• Provide quality oversight during health authority interactions and inspections.
• Review INDs, CTAs, amendments, and regulatory documents, ensuring quality and translations meet requirements.
• Perform ALCOA+ checks of submissions and labeling documentation.
• Approve change controls, IP labels proofs, IMPD, and study manuals; ensure regulatory alignment.
• Support vendor qualification, QTA maintenance, and audits; oversee supplier/packaging activities.
• Assess impact of new regulations on the QMS; author and approve SOPs and training.

Skills

Regulatory compliance

Quality assurance

GxP knowledge

Global submissions

Risk assessment

Education

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

Advanced degree preferred

Job description

SUN PHARMA in Princeton, NJ is seeking a Senior Regulatory Compliance Manager to provide independent QA assessment of global regulatory compliance activities supporting clinical development and labeling for IP assets. You will ensure submissions, quality systems, and vendor deliverables meet global requirements and drive inspection readiness.

Responsibilities include leading quality reviews of labeling, partnering with Regulatory Affairs, Clinical Development, and QA teams, and advising on