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

Dart NeuroScience LLC

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Location:
San Diego, CA
Posted Date:
5/25/2017
Position Type:
Full time
Job Code:
17-037 #804429
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Regulatory, Regulatory Affairs,

Job Description

Working in a team environment, the Regulatory Affairs 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
Contribute to product development plans (PDP) and 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 reportsInterface 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

Compliance

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
Author and review standard operating procedures (SOPs); ensure SOPs are in compliance with current regulatory requirements
Monitor company progress toward fulfillment of regulatory commitments

Requirements

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