Neurocrine
Regulatory Strategy Manager - Immunology
US CA San Diego
Sponsorship not specified$133k-$182kDetected 20 days ago
Project ManagementClinical TrialsFDA RegulatoryResearchLeadershipCommunicationCollaborationProblem SolvingRegulatory Affairs
About the role
- Responsible for supporting regulatory strategy execution for development programs.
- DSUR/Annual Reports, clinical protocols, clinical study reports, application amendments and postapproval activities.
- Provide regulatory representation on cross-functional teams as directed.
Responsibilities
- Act as the regulatory lead for clinical trials at various stages of development, providing strategic regulatory guidance and ensuring alignment with project objectives
- 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
- Works closely with the Director of Regulatory Affairs to prepare regulatory submissions (strategy, authoring, timeline planning, etc.) and to maintain department regulatory processes.
- Collaboratively develop regulatory strategies to support CMC, nonclinical, and clinical activities across various development programs.
Requirements
- Experience with FDA regulations and ICH guidelines for regulatory submissions.
- PharmD or PhD AND 2+ years of related experience
- Has knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines
- Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
- Ability to work independently with minimal direction, including functional representation within project teams in order to attain group goals
Nice to have
- Demonstrated understanding of laws, regulations, standards, and guidance governing drug development (e.g., US regulatory knowledge) a plus
Compensation
- Develop, review and/or file INDs, CTAs, briefing documents and maintenance of development and approved applications including authoring DSURs, annual reports, amendments as needed
Company info
- Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. ( *in collaboration with AbbVie )
- About the Role:
- Responsible for supporting regulatory strategy execution for development programs. Works closely with the Director of Regulatory Affairs to prepare regulatory submissions (strategy, authoring, timeline planning, etc.) and to maintain department regulatory processes. Coordinates, prepares, and contributes to the development of document packages for regulatory submissions including IND/CTA, NDA/BLA. DSUR/Annual Reports, clinical protocols, clinical study reports, application amendments and postapproval activities. Ensures submission compliance with local and regional regulatory requirements, company policies, and internal quality and compliance standards. Provide regulatory representation on cross-functional teams as directed. Collaboratively develop regulatory strategies to support CMC, nonclinical, and clinical activities across various development programs. Provide regulatory review of clinical study documentation, including review of clinical protocols, informed consent documents, clinical study recruitment materials. Perform regulatory research and communicate new/emerging regulations to management and project teams. _
- Your Contributions (include, but are not limited to):
- Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs.
- We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders.
- The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas.
- For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions.
- We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science.
- For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. ( *in collaboration with AbbVie )
- to relieve suffering for people with great needs.
- Ensures submission compliance with local and regional regulatory requirements, company policies, and internal quality and compliance standards.
- Ensures the company is adhering to all applicable government regulations
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