BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Associate Director, Regulatory Affairs to work for a leading San Diego biotechnology company.
Associate Director, Regulatory Affairs
Working in a team environment, the Regulatory Associate Director will be responsible for development of 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 products.
Represent the Regulatory Affairs department on multidisciplinary product development teams
Develop and implement regulatory strategy for one or more programs
Research regulatory precedent related to product class and therapeutic area(s) and assess implications for product development/registration
Contribute to global product development plans (PDP) and target product profiles (TPP)
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 team and lead the conduct of milestone development meetings with regulatory health authority
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 and review 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 life science discipline; advanced degree preferred; Regulatory Affairs Certification a plus
Minimum 5 - 7 years experience in pharmaceutical Regulatory Affairs with focus in development of drugs/biologics
Direct experience in preparation, submission and lifecycle management of investigational/marketing applications in eCTD format
Experience negotiating and directly interfacing with US and international 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
BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. The goal of BioPhase is to...