San Diego, CA
Senior Manager, Regulatory Affairs Strategy
General Job Description:
Who We Are:
At Neurocrine Biosciences - voted one of San Diego's top places to work in 2018 - we pride ourselves on having a strong, distinctive and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve patient suffering and enhance lives.
What We Do:
Neurocrine Biosciences is a biopharmaceutical company focused on developing treatments for neurological and endocrine related disorders.
About the Role:
Responsible for supporting regulatory strategy execution for development programs. Works closely with the Director of Regulatory Affairs to prepare regulatory submissions (authoring, timeline planning, etc.) and to maintain department regulatory processes.
YOUR CONTRIBUTIONS (include, but are not limited 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.
Provide regulatory assistance and 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 maintain 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.
Complete assigned activities with the project team.
Perform other duties as required.
Bachelor’s degree in Life/Health Sciences and 5 years industry experience, of which a minimum of 3 years must be Regulatory Affairs experience in drug development at a research-based pharmaceutical company, including two years in a leadership capacity. An advanced degree in a life science is preferred.
Ability to work independently with minimal direction, including functional representation within project teams and committees in order to attain group goals.
- Proven track record and experience with regulatory submissions with a thorough understanding of FDA regulations and ICH guidelines.
Demonstrated understanding of laws, regulations, standards, and guidance governing drug development. Ex-US regulatory knowledge a plus.
Excellent verbal and written communication skills.
Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.
Application Information & Contact (How to Apply)
Please apply by visiting the Neurocrine career page.
Learn more about Neurocrine here