Regulatory Submissions Lead, CMC & DMF

U023 (FCRS = US023) Sandoz Inc; Princeton (NJ); Hybrid; USD 94,000 - 174,000; Full time

Benefits offered by this job

Health insurance

401(k) eligibility

Paid time off

Job summary

Sandoz Inc. in Princeton, NJ seeks a Regulatory Specialist in Regulatory Affairs CMC to prepare and maintain regulatory submissions, including ANDAs and DMFs, across product lifecycles.

The role collaborates with cross-functional teams to ensure FDA compliance and timely filings. The position offers a hybrid work arrangement with the US headquarters and requires processing Type II/Type V DMFs, labeling reviews, and routine regulatory assessments.

Qualifications

• Bachelor’s degree in a scientific field is required.
• 3–5 years in Pharmaceutical Regulatory Affairs.
• Ability to manage multiple projects and regulatory deadlines.
• Strong communication and cross-functional collaboration.
• Experience with FDA regulations and DMF/ANDA submissions is essential.

Responsibilities

• Prepare, submit, and maintain regulatory submissions including ANDAs, amendments, supplements, annual reports, and responses to FDA deficiencies.
• Prepare, submit, and maintain Type II and Type V DMFs, amendments, annual reports, letters of authorization and responses to FDA deficiencies.
• Interacts with FDA regarding submissions and regulatory inquiries; perform regulatory assessments of change controls.
• Maintain regulatory records, databases, and document management systems per company procedures.
• Review labeling change control requests and approve revised labeling documents.

Skills

Regulatory submissions

Organization & execution

Agency & stakeholder communication

Analytical thinking

CMC technical knowledge

Education

Bachelor's degree in a scientific field

Advanced degree (MS, Pharm D) in a scientific discipline

Job description

Sandoz Inc. in Princeton, NJ seeks a Regulatory Specialist in Regulatory Affairs CMC to prepare and maintain regulatory submissions, including ANDAs and DMFs, across product lifecycles.

The role collaborates with cross-functional teams to ensure FDA compliance and timely filings. The position offers a hybrid work arrangement with the US headquarters and requires processing Type II/Type V DMFs, labeling reviews, and routine regulatory assessments.