Regulatory & Business Continuity Specialist

Sun Pharmaceutical Industries, Inc.; Princeton (NJ); Hybride; USD 103 000 - 125 000; Plein temps

Résumé du poste

Sun Pharmaceutical Industries, Inc (USA) in Princeton, NJ is seeking a Senior Associate Regulatory and Business Continuity to ensure regulatory compliance and provide FDA-aligned assessments. You will work closely with the Regulatory & Business Continuity Sr.

Manager to support timely completion of activities and effective stakeholder communications, with duties spanning submissions, GAP analysis, and regulatory oversight.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry or life science required.
• Advanced degree in Regulatory Affairs or pharmaceutical science preferred.
• Strong verbal and written communication and interpersonal skills.
• Ability to work in a fast paced, changing environment.

Responsabilités

• Prepare submissions (ANDAs, amendments, supplements, annual reports) to support commercial business and FDA compliance.
• Coordinate with stakeholders for deficiency responses for submissions.
• Review CMC submissions to meet FDA requirements for acceptability and approvability.
• Prepare, review and submit eCTD submissions and SPLs.
• Assess submissions for gaps and summarize deficiency reports for FDA submission readiness.
• Work cross-functionally with sites/CMOs, PM, and R&D.
• Maintain regulatory databases for completeness and accuracy.

Connaissances

Strong verbal and written comms

Multi-project management

Formation

Bachelor’s degree in Pharmacy/ Chemistry/ Life science

Advanced degree in Regulatory Affairs or pharmaceutical science

Outils

TrackWise

Microsoft Office

Adobe Acrobat Pro

Description du poste

Sun Pharmaceutical Industries, Inc (USA) in Princeton, NJ is seeking a Senior Associate Regulatory and Business Continuity to ensure regulatory compliance and provide FDA-aligned assessments. You will work closely with the Regulatory & Business Continuity Sr.

Manager to support timely completion of activities and effective stakeholder communications, with duties spanning submissions, GAP analysis, and regulatory oversight.