CMC Regulatory Affairs Director - Global Submissions

Teva Pharmaceuticals; West Chester (Chester County); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Health Insurance

401(k) with employer match

Paid time off & holidays

Life and Disability Insurance

Stock Purchase Plan

Job summary

Teva Pharmaceuticals in the United States seeks a Director, Regulatory Affairs CMC to lead regulatory strategies for development and post-marketing activities. The role focuses on compiling, organizing, and assessing regulatory submissions, coordinating with global teams, and ensuring CMC sections meet health authority expectations.

The ideal candidate brings extensive CMC regulatory experience, strong writing and project management skills, and the ability to lead cross-functional teams across

Qualifications

• Bachelor’s degree in scientific discipline.
• 8+ years of pharmaceutical industry experience.
• 5+ years of Regulatory Affairs experience.

Responsibilities

• Provide accurate and timely CMC regulatory guidance to teams engaged in the development of new products by assessing and interpreting FDA/ICH/EMEA regulatory guidances and directives, and evaluating and communicating their applicability to the development teams.
• Develop and communicate effective CMC regulatory strategies for development and post marketing submission activities. Determine and communicate appropriate risk analyses and timeline development.
• Coordinate, author and review the CMC sections of IND, NDA and CTA filings. Compile and review CMC regulatory documents, including but not limited to Development Reports, Validation Protocols and Reports, NDA supplements, IND and NDA Annual Reports, and Responses to FDA information requests. Assist in the submission of regulatory correspondence to the FDA.
• Support the global registration initiative for marketed products by liaising with Regulatory counterparts in Europe, Israel, Canada and Rest of World assisting with preparation of complete registration dossiers to be submitted to foreign Health Authorities.
• Lead the review of internal CMC controlled documentation including but not limited to standard operating procedures, test methods, specifications and protocols
• Perform change management to establish the regulatory impact of changes and ensure compliance of registered commitments.
• Assist in planning and conducting meetings with regulatory agencies for routine meetings and interactions.

Skills

Regulatory affairs expertise

Cross-functional collaboration

Regulatory writing

FDA/ICH knowledge

Education

Bachelor’s degree in scientific discipline

Job description

Teva Pharmaceuticals in the United States seeks a Director, Regulatory Affairs CMC to lead regulatory strategies for development and post-marketing activities. The role focuses on compiling, organizing, and assessing regulatory submissions, coordinating with global teams, and ensuring CMC sections meet health authority expectations.

The ideal candidate brings extensive CMC regulatory experience, strong writing and project management skills, and the ability to lead cross-functional teams across