Sr. Regulatory Strategy Manager
Neurocrine Biosciences
- San Diego, CA
- Permanent
- Full-time
- Provide project leadership to develop, review and/or file INDs, CTAs, briefing documents and maintenance of development and approved applications including authoring DSURs, annual reports, amendments as needed
- Provide regulatory representation and expertise on cross-functional product development teams as needed. Collaboratively develop global regulatory strategies to support CMC, nonclinical, and clinical activities across various development programs
- Maintain an awareness, through regulatory intelligence, of global regulatory strategies for products in the same class/indication and determine applicability to Company programs
- Develop and manage project timelines for regulatory submissions
- Lead, coordinate, author, critically review and provide strategic input on regulatory filing documents
- Lead the regulatory review of clinical study documentation, including review of clinical protocols, informed consent documents, and clinical study recruitment materials
- Conduct regulatory research and analysis, develop and communicate recommendations regarding new/emerging regulations to management and project teams
- Develop and implement standard operating procedures and department working practices
- Ensures the company is adhering to all applicable government regulations
- Interface directly with US and international regulatory authorities on specific projects when required
- Lead or partner with team members to complete assigned activities with the project team
- Mentor or train less experienced colleagues to provide an example of innovation and excellence
- Contribute to the development of strategic Regulatory plans and processes
- Other duties as assigned