Director, Regulatory Affairs

Job Reference: #31685 Add to saved jobs

  • Salary $190000
  • Location New Jersey, United States
  • Permanent
  • Sector Pharmaceuticals

Job Summary

My client are a high-tech global biopharma focused on the production of insulin products. Due to their continued growth, they are seeking an Director Regulatory Affairs to outline regulatory strategy and coordinate regulatory interactions.


Job Overview

-Actively contribute to the development and implementation of global regulatory strategies for assigned projects.

-Serve as the primary point of contact with health authorities, especially FDA and EMA.

-Act as a regulatory liaison to interact with the external partners, and internal-functional departments; participate in or lead project teams.

-Be responsible for managing the preparation, compilation, and submission of regulatory applications, such as INDs / CTAs, BLAs / MAAs, and supplemental filings.

-Collaborate with CRO’s and cross-functional partners throughout the drug development process to ensure compliance with regulatory requirements.


Skills Required

-Minimum Bachelor’s degree in a scientific or related disciplines, 7+ years of pharmaceutical industrial experience, minimum 5 years in Regulatory Affairs. Global experience a plus.

-Working knowledge of global regulations and guidance as they relate to the global regulatory strategy.

-Working experience of eCTD submission.

-Excellent organizational, oral and written communication skills. Fluent in Chinese preferred, but not required.


Contact Details

For more information, please contact Kasey Dillon via phone: 646.569.9081 or by email: kasey@peoplewithchemistry.com for a confidential discussion.


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