Manager/Senior Manager, Regulatory Affairs - San Diego, CA | Biospace
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Manager/Senior Manager, Regulatory Affairs

Dart NeuroScience LLC

San Diego, CA
Posted Date:
Position Type:
Full time
Job Code:
15-028 #765912
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Regulatory, Regulatory Affairs,

Job Description

Working in a team environment, the Regulatory Affairs Manager/Senior 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

Other duties may be assigned as needed


•   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