Manager, Regulatory Affairs

Hiring Company: Dart NeuroScience

Job Code: 17-063 #814414

Location: San Diego, CA

Job Type: Full Time

Description: Job Summary:

Working in a team environment, the Regulatory Affairs Manager will be responsible for executing regulatory strategy as well as hands-on management of all technical and operational aspects related to the regulatory lifecycle (e.g., from preclinical candidate designation through registration) of assigned DNS products.

Strategic Planning

• Represent the Regulatory Affairs department on multidisciplinary product development teams
• Participate in the development and implementation of regulatory strategy for one or more programs
• Research regulatory precedent related to product class and therapeutic area(s) and assess implications for DNS product development/registration
• Provide input to product development plans (PDP); lead preparation of target product profile (TPP)

Regulatory Operations

• Manage all operational aspects of regulatory submissions, including maintaining timelines; organizing submission content; and coordinating the internal/external authoring and review of components of original investigational drug applications, amendments, and IND safety and annual reports
• Interface with external Regulatory Operations group in the compilation of regulatory submissions in electronic common technical document (eCTD) format
• Prepare and/or implement standard regulatory submission content templates
• Prepare briefing documents for milestone regulatory meetings


• Review and communicate current and emerging regulatory requirements for quality, preclinical, and clinical programs to ensure compliance of all development activities with applicable US and international regulations and guidelines
• Participate in the development of standard operating procedures (SOPs); ensure SOPs are in compliance with current regulatory requirements
• Monitor company progress toward fulfillment of regulatory commitments


• Bachelor degree in a life sciences discipline; advanced degree preferred
• Minimum of 5 years pharmaceutical Regulatory Affairs experience with focus in development of drugs/biologics
• Hands-on experience in authoring, preparation, submission and lifecycle management of investigational/marketing applications in eCTD format
• In depth knowledge of GXP/ICH guidelines and regulations
• Experience in CNS-related therapeutic area a plus
• Strong written and verbal communication, analytical, organizational and interpersonal skills
• Ability to work in a dynamic environment with a high degree of flexibility
• Proven ability to interact effectively across multiple functional groups and projects

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