Global Regulatory QA Lead – Labelling & Submissions

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

Ventajas ofrecidas por este puesto de trabajo

Medical, dental and vision coverage

Life insurance

Disability insurance

401(k) savings plan

Flexible spending accounts

Paid time off

Descripción de la vacante

Sun Pharmaceutical Industries seeks a Senior Regulatory Compliance Manager to lead QA reviews of regulatory labeling and ensure global submission readiness across Innovative Medicines programs. This role collaborates with Regulatory, Clinical Development, and external partners to uphold GxP standards and regulatory expectations.

The ideal candidate brings 10+ years in development QA, strong labeling governance experience, and deep knowledge of ICH/Q9/Q10 frameworks, supporting inspections and

Formación

• Minimum 10 years in Development Quality Assurance or related GxP-regulated functions.
• Experience supporting global regulatory submissions for innovative medicines.

Responsabilidades

• Lead independent quality reviews of regulatory labelling in global submissions strategies for all assigned Innovative Medicines Assets.
• Partner with Global Regulatory Affairs, Clinical Development, Clinical Operations, Pharmacovigilance, Supply Chain, and external service providers to ensure compliance with global regulations, GCP, GMP, GDP, and internal standards.
• Represent Development Quality Assurance on cross-functional labeling governance committees and influence strategic quality decisions for submission success.
• Maintain expertise in GCP, GMP, GDP, ICH E6(R3), ICH Q9, and ICH Q10; lead risk assessments and provide guidance aligned with ICH Q9.
• Provide quality oversight during health authority interactions, inspections, and regulatory activities.
• Review INDs, CTAs, amendments, annual reports, investigator brochures, DSURs, IMPD, marketing applications, and health authority responses.
• Perform ALCOA+ checks of global submissions and labeling documentation.
• Review/approve change control, IP labels proofs, IMPD, and IP study manuals with translations and regulatory certificates per FDA/EMA/HC/EU requirements.
• Support vendor qualification, QTA governance, SCARS, and for-cause audits of suppliers.
• Assess impact of emerging regulations on the Quality Management System.
• Author/review revised or new SOPs, work instructions, and templates; lead training on SOPs.
• Support inspection readiness and health authority inspections.
• Drive continuous improvement through KPI tracking and management reviews.

Conocimientos

QA leadership

GxP compliance

Regulatory labeling

Cross-functional collaboration

Risk assessment

Educación

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

Advanced degree preferred

Herramientas

QMS software

ALCOA+ practices

Descripción del empleo

Sun Pharmaceutical Industries seeks a Senior Regulatory Compliance Manager to lead QA reviews of regulatory labeling and ensure global submission readiness across Innovative Medicines programs. This role collaborates with Regulatory, Clinical Development, and external partners to uphold GxP standards and regulatory expectations.

The ideal candidate brings 10+ years in development QA, strong labeling governance experience, and deep knowledge of ICH/Q9/Q10 frameworks, supporting inspections and