Associate Director, Regulatory Affairs

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Reports To: Vice President, Regulatory Affairs 
Location: Remote or San Diego, CA 

Position Summary 

Working in a team environment, the Associate Director, Regulatory Affairs 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 Longboard Pharmaceutical products. 

Responsibilities 

  • Strategic Planning o 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 LP product development/registration 
  • Contribute to global product development plans and target product profiles 
  • Lead preparation of pediatric investigation plans and rare disease designation applications 
  • Operations o 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, safety and annual reports 
  • Interface with external Regulatory Operations group in the compilation of regulatory submissions in electronic common technical document 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 
  • Compliance o 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 

Minimum Requirements 

  • Bachelor’s degree in life sciences required; advanced degree preferred 
  • Regulatory Affairs Certification (RAC) 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, 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 and rare disease development a plus 
  • Strong written and verbal communication, and ability to communicate regulatory strategy to key stakeholders at all levels of the organization 
  • High level of 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 
  • Ability to travel up to 20% (US and International)