Associate Director, Regulatory Affairs
Job Category:Regulatory Affairs
Who We Are
Dart NeuroScience LLC (DNS) is a privately held company with offices in San Diego, CA.
DNS is a company discovering new technologies and developing new therapies to help maintain cognitive vitality throughout life. DNS's mission is to become the leading specialized pharmaceutical company for memory disorders by focusing on the discovery and development of innovative drugs with new mechanisms of action. These discoveries are firmly based in a careful examination of the genes involved in the reorganization of synaptic connections in the brain, a cellular/molecular process which underlies both implicit (motor skills) and explicit (facts and events) forms of memory.
Our unique company culture engages employees by promoting thought-provoking investigation and targeted research opportunities. Our collegial environment also recognizes the value of stimulating cross-functional communication and collaboration as catalysts in generating the creative spark that inspires novel approaches and produces ground-breaking results. We want to attract, retain, and reward the top talent in our field. If you are looking for a productive, meaningful career path in the area of neuroscience, we would like to hear from you!
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 DNS products.
Essential Duties and Responsibilities (Other duties may be assigned as needed)
- 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 DNS product development/registration
- Contribute to content and lead preparation of 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
- Serve as primary liaison for communication with regulatory health authority on assigned programs
- Prepare team for 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 a life sciences discipline; advanced degree preferred; Regulatory Affairs Certification a plus
- Minimum 7 years pharmaceutical Regulatory Affairs experience with focus in development of drugs/biologics
- Direct experience in preparation, submission and lifecycle management of investigational/marketing applications in eCTD format, including as primary Regulatory author
- 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, 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
DNS offers competitive salaries and a great benefits package including paid holidays, incentive bonuses, healthcare, vision, dental, long-term disability, life insurance, flexible spending, and a 401(k) retirement savings plan. Click here to learn more.
Dart NeuroScience is an Equal Opportunity Employer/Minorities/Women/Disability/Veterans.