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.
-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.
-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.
For more information, please contact Kasey Dillon via phone: 646.569.9081 or by email: firstname.lastname@example.org for a confidential discussion.